Trial Outcomes & Findings for Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children (NCT NCT02747927)
NCT ID: NCT02747927
Last Updated: 2025-11-19
Results Overview
The VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific reverse transcriptase polymerase chain reaction (RT-PCR). The primary endpoint of VE was assessed using the number of virologically-confirmed dengue fever cases that occurred during Part 1.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
20099 participants
Primary outcome timeframe
30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 1 (Month 15) when at least 120 cases of dengue fever were confirmed and minimum duration of participant follow-up was 12 months post-second vaccination
Results posted on
2025-11-19
Participant Flow
Participants took part in the study at various investigative sites globally from 26 April 2016 to 28 June 2024.
Healthy children and adolescents were randomized in a 2:1 ratio to receive either tetravalent dengue vaccine (TDV) or placebo followed by a booster vaccination.
Participant milestones
| Measure |
Placebo
Participants received placebo-matching TDV, 0.5 milliliter (mL), subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
Part 1: Vaccine Efficacy (Months 0-15)
STARTED
|
6698
|
13401
|
|
Part 1: Vaccine Efficacy (Months 0-15)
Safety Set
|
6687
|
13380
|
|
Part 1: Vaccine Efficacy (Months 0-15)
Treatment Misallocations
|
1
|
3
|
|
Part 1: Vaccine Efficacy (Months 0-15)
COMPLETED
|
6520
|
13035
|
|
Part 1: Vaccine Efficacy (Months 0-15)
NOT COMPLETED
|
178
|
366
|
|
Part 2: Additional VE (Months 16-21)
STARTED
|
6520
|
13035
|
|
Part 2: Additional VE (Months 16-21)
COMPLETED
|
6488
|
12963
|
|
Part 2: Additional VE (Months 16-21)
NOT COMPLETED
|
32
|
72
|
|
Part 3: Long Term Safety & VE (3 Years)
STARTED
|
6488
|
12963
|
|
Part 3: Long Term Safety & VE (3 Years)
COMPLETED
|
6080
|
12179
|
|
Part 3: Long Term Safety & VE (3 Years)
NOT COMPLETED
|
408
|
784
|
|
Part 4: Booster VE & Safety (13 Months)
STARTED
|
2986
|
5991
|
|
Part 4: Booster VE & Safety (13 Months)
Safety Set - Booster
|
2985
|
5990
|
|
Part 4: Booster VE & Safety (13 Months)
Treatment-Misallocations
|
1
|
1
|
|
Part 4: Booster VE & Safety (13 Months)
COMPLETED
|
2940
|
5890
|
|
Part 4: Booster VE & Safety (13 Months)
NOT COMPLETED
|
46
|
101
|
|
Part 5: Booster VE & Safety (1 Year)
STARTED
|
2940
|
5890
|
|
Part 5: Booster VE & Safety (1 Year)
COMPLETED
|
2842
|
5672
|
|
Part 5: Booster VE & Safety (1 Year)
NOT COMPLETED
|
98
|
218
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo-matching TDV, 0.5 milliliter (mL), subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
Part 1: Vaccine Efficacy (Months 0-15)
Adverse Event
|
5
|
14
|
|
Part 1: Vaccine Efficacy (Months 0-15)
Lost to Follow-up
|
13
|
26
|
|
Part 1: Vaccine Efficacy (Months 0-15)
Pregnancy
|
19
|
42
|
|
Part 1: Vaccine Efficacy (Months 0-15)
Protocol Violation
|
2
|
5
|
|
Part 1: Vaccine Efficacy (Months 0-15)
Withdrawal by Participant and/or Participants Parent/Guardian
|
131
|
260
|
|
Part 1: Vaccine Efficacy (Months 0-15)
Without Adult Consent in Place
|
1
|
4
|
|
Part 1: Vaccine Efficacy (Months 0-15)
Reason not Specified
|
7
|
15
|
|
Part 2: Additional VE (Months 16-21)
Adverse Event
|
0
|
1
|
|
Part 2: Additional VE (Months 16-21)
Lost to Follow-up
|
4
|
8
|
|
Part 2: Additional VE (Months 16-21)
Pregnancy
|
11
|
17
|
|
Part 2: Additional VE (Months 16-21)
Withdrawal by Participant&/ortheir Parent/Guardian
|
13
|
33
|
|
Part 2: Additional VE (Months 16-21)
Without Adult Consent in Place
|
1
|
7
|
|
Part 2: Additional VE (Months 16-21)
Reason Not Specified
|
3
|
6
|
|
Part 3: Long Term Safety & VE (3 Years)
Adverse Event
|
6
|
10
|
|
Part 3: Long Term Safety & VE (3 Years)
Lost to Follow-up
|
67
|
149
|
|
Part 3: Long Term Safety & VE (3 Years)
Pregnancy
|
120
|
228
|
|
Part 3: Long Term Safety & VE (3 Years)
Protocol Violation
|
1
|
2
|
|
Part 3: Long Term Safety & VE (3 Years)
Withdrawal by Participant and/or Participants Parent/Guardian
|
119
|
227
|
|
Part 3: Long Term Safety & VE (3 Years)
Without Adult Consent in Place
|
82
|
150
|
|
Part 3: Long Term Safety & VE (3 Years)
Reason Not Specified
|
13
|
18
|
|
Part 4: Booster VE & Safety (13 Months)
Adverse Event
|
1
|
3
|
|
Part 4: Booster VE & Safety (13 Months)
Lost to Follow-up
|
4
|
13
|
|
Part 4: Booster VE & Safety (13 Months)
Pregnancy
|
8
|
15
|
|
Part 4: Booster VE & Safety (13 Months)
Withdrawal by Participant and/or Participants Parent/Guardian
|
29
|
60
|
|
Part 4: Booster VE & Safety (13 Months)
Without Adult Consent in Place
|
0
|
1
|
|
Part 4: Booster VE & Safety (13 Months)
Reason Not Specified
|
4
|
9
|
|
Part 5: Booster VE & Safety (1 Year)
Adverse Event
|
0
|
3
|
|
Part 5: Booster VE & Safety (1 Year)
Lost to Follow-up
|
8
|
30
|
|
Part 5: Booster VE & Safety (1 Year)
Pregnancy
|
18
|
27
|
|
Part 5: Booster VE & Safety (1 Year)
Withdrawal by Subject
|
18
|
40
|
|
Part 5: Booster VE & Safety (1 Year)
Without Adult Consent in Place
|
14
|
29
|
|
Part 5: Booster VE & Safety (1 Year)
Reason Not Specified
|
40
|
89
|
Baseline Characteristics
Number analyzed is number of participants with data available for height at Baseline.
Baseline characteristics by cohort
| Measure |
Placebo
n=6317 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=12704 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
Total
n=19021 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.6 years
STANDARD_DEVIATION 3.34 • n=6317 Participants
|
9.6 years
STANDARD_DEVIATION 3.35 • n=12704 Participants
|
9.6 years
STANDARD_DEVIATION 3.35 • n=19021 Participants
|
|
Sex: Female, Male
Female
|
3098 Participants
n=6317 Participants
|
6314 Participants
n=12704 Participants
|
9412 Participants
n=19021 Participants
|
|
Sex: Female, Male
Male
|
3219 Participants
n=6317 Participants
|
6390 Participants
n=12704 Participants
|
9609 Participants
n=19021 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2379 Participants
n=6317 Participants
|
4821 Participants
n=12704 Participants
|
7200 Participants
n=19021 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2934 Participants
n=6317 Participants
|
5888 Participants
n=12704 Participants
|
8822 Participants
n=19021 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
708 Participants
n=6317 Participants
|
1353 Participants
n=12704 Participants
|
2061 Participants
n=19021 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=6317 Participants
|
2 Participants
n=12704 Participants
|
3 Participants
n=19021 Participants
|
|
Race/Ethnicity, Customized
White
|
131 Participants
n=6317 Participants
|
284 Participants
n=12704 Participants
|
415 Participants
n=19021 Participants
|
|
Race/Ethnicity, Customized
More than one race or Unknown
|
164 Participants
n=6317 Participants
|
356 Participants
n=12704 Participants
|
520 Participants
n=19021 Participants
|
|
Region of Enrollment
Brazil
|
504 Participants
n=6317 Participants
|
1091 Participants
n=12704 Participants
|
1595 Participants
n=19021 Participants
|
|
Region of Enrollment
Colombia
|
1155 Participants
n=6317 Participants
|
2268 Participants
n=12704 Participants
|
3423 Participants
n=19021 Participants
|
|
Region of Enrollment
Dominican Republic
|
533 Participants
n=6317 Participants
|
1007 Participants
n=12704 Participants
|
1540 Participants
n=19021 Participants
|
|
Region of Enrollment
Nicaragua
|
239 Participants
n=6317 Participants
|
512 Participants
n=12704 Participants
|
751 Participants
n=19021 Participants
|
|
Region of Enrollment
Panama
|
944 Participants
n=6317 Participants
|
1930 Participants
n=12704 Participants
|
2874 Participants
n=19021 Participants
|
|
Region of Enrollment
Philippines
|
1306 Participants
n=6317 Participants
|
2554 Participants
n=12704 Participants
|
3860 Participants
n=19021 Participants
|
|
Region of Enrollment
Sri Lanka
|
683 Participants
n=6317 Participants
|
1368 Participants
n=12704 Participants
|
2051 Participants
n=19021 Participants
|
|
Region of Enrollment
Thailand
|
953 Participants
n=6317 Participants
|
1974 Participants
n=12704 Participants
|
2927 Participants
n=19021 Participants
|
|
Height
|
134.87 cm
STANDARD_DEVIATION 18.976 • n=6313 Participants • Number analyzed is number of participants with data available for height at Baseline.
|
134.84 cm
STANDARD_DEVIATION 19.151 • n=12696 Participants • Number analyzed is number of participants with data available for height at Baseline.
|
134.85 cm
STANDARD_DEVIATION 19.092 • n=19009 Participants • Number analyzed is number of participants with data available for height at Baseline.
|
|
Weight
|
33.77 kg
STANDARD_DEVIATION 14.506 • n=6317 Participants • Number analyzed is number of participants with data available for weight at Baseline.
|
33.98 kg
STANDARD_DEVIATION 14.951 • n=12697 Participants • Number analyzed is number of participants with data available for weight at Baseline.
|
33.91 kg
STANDARD_DEVIATION 14.805 • n=19014 Participants • Number analyzed is number of participants with data available for weight at Baseline.
|
|
Body Mass Index (BMI)
|
17.67 kg/m^2
STANDARD_DEVIATION 3.645 • n=6313 Participants • Number analyzed is number of participants with data available for BMI at Baseline.
|
17.76 kg/m^2
STANDARD_DEVIATION 3.831 • n=12689 Participants • Number analyzed is number of participants with data available for BMI at Baseline.
|
17.73 kg/m^2
STANDARD_DEVIATION 3.770 • n=19002 Participants • Number analyzed is number of participants with data available for BMI at Baseline.
|
PRIMARY outcome
Timeframe: 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 1 (Month 15) when at least 120 cases of dengue fever were confirmed and minimum duration of participant follow-up was 12 months post-second vaccinationPopulation: PPS included all participants in the FAS who had no major protocol violations. FAS included all randomized participants who received at least 1 dose of the trial vaccines. Overall number of participants analyzed is the number of participants with data available for analyses.
The VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific reverse transcriptase polymerase chain reaction (RT-PCR). The primary endpoint of VE was assessed using the number of virologically-confirmed dengue fever cases that occurred during Part 1.
Outcome measures
| Measure |
Placebo
n=6316 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=12700 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
Vaccine Efficacy (VE) of Two Doses of Tetravalent Dengue Vaccine Candidate (TDV) in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype
|
149 number of cases
|
61 number of cases
|
SECONDARY outcome
Timeframe: From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21)Population: PPS included all participants in the FAS who had no major protocol violations. FAS included all randomized participants who received at least 1 dose of the trial vaccines. Overall number of participants analyzed is the number of participants with data available for analyses.
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases requiring hospitalization due to virologically-confirmed dengue fever that occurred during Part 1 and Part 2.
Outcome measures
| Measure |
Placebo
n=6316 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=12700 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype
|
66 number of cases
|
13 number of cases
|
SECONDARY outcome
Timeframe: From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21)Population: PPS included all participants in the FAS who had no major protocol violations. FAS included all randomized participants who received at least 1 dose of the trial vaccines. Overall number of participants analyzed is the number of participants with data available for analyses.
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases that occurred during Part 1 and Part 2.
Outcome measures
| Measure |
Placebo
n=6316 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=12700 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Each Dengue Serotype
DENV-3
|
60 number of cases
|
63 number of cases
|
|
VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Each Dengue Serotype
DENV-1
|
62 number of cases
|
38 number of cases
|
|
VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Each Dengue Serotype
DENV-2
|
80 number of cases
|
8 number of cases
|
|
VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Each Dengue Serotype
DENV-4
|
5 number of cases
|
5 number of cases
|
SECONDARY outcome
Timeframe: From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21)Population: PPS included all participants in the FAS who had no major protocol violations. FAS included all randomized participants who received at least 1 dose of the trial vaccines. Overall number of participants analyzed is the number of participants with seronegative baseline status and with data available for analyses.
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases that occurred during Part 1 and Part 2.
Outcome measures
| Measure |
Placebo
n=1726 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=3531 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seronegative at Baseline
|
56 number of cases
|
39 number of cases
|
SECONDARY outcome
Timeframe: From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21)Population: PPS included all participants in the FAS who had no major protocol violations. FAS included all randomized participants who received at least 1 dose of the trial vaccines. Overall number of participants analyzed is the number of participants with seropositive baseline status and with data available for analyses.
VE is defined as 1 - (λv/λC), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases that occurred during Part 1 and Part 2.
Outcome measures
| Measure |
Placebo
n=4589 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=9167 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seropositive at Baseline
|
150 number of cases
|
75 number of cases
|
SECONDARY outcome
Timeframe: From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21)Population: PPS included all participants in the FAS who had no major protocol violations. FAS included all randomized participants who received at least 1 dose of the trial vaccines. Overall number of participants analyzed is the number of participants with data available for analyses.
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. Severe cases were determined by Adjudication Committee. VE was assessed using the number of severe cases due to virologically-confirmed dengue fever that occurred during Part 1 and Part 2.
Outcome measures
| Measure |
Placebo
n=6316 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=12700 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
VE of Two Doses of TDV in Preventing Virologically-Confirmed Severe Dengue Fever Induced by Any Dengue Serotype
|
1 number of cases
|
2 number of cases
|
SECONDARY outcome
Timeframe: Days 1 through 7 after each vaccinationPopulation: The Safety Set (SS)- Immunogenicity Subset included all randomized participants in the safety/immunogenicity subset who received at least 1 dose of the trial vaccines (TDV or placebo). Number analyzed is the number of participants with data available for analyses for the specified category.
Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred within 7 days after each vaccination. The participant/legal guardian recorded the severity of each AE (except erythema and swelling) according to the diary card instruction as none, mild, moderate, or severe. Severity grades for erythema and swelling were derived from the recorded diameters. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation.
Outcome measures
| Measure |
Placebo
n=1329 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=2663 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After First Vaccination; Erythema; Mild
|
0 percentage of participants
|
1.0 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After First Vaccination; Swelling; Severe
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After First Vaccination; Erythema; Severe
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After First Vaccination; Swelling; Mild
|
0.6 percentage of participants
|
1.9 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After First Vaccination; Swelling; Moderate
|
0 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After Second Vaccination; Pain: Mild
|
13.3 percentage of participants
|
18.2 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After Second Vaccination; Pain: Moderate
|
1.2 percentage of participants
|
2.5 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After Second Vaccination; Pain: Severe
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After Second Vaccination; Erythema; Mild
|
0 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After Second Vaccination; Erythema; Moderate
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After Second Vaccination; Erythema; Severe
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After Second Vaccination; Swelling; Mild
|
0.6 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After Second Vaccination; Swelling; Moderate
|
0 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After Second Vaccination; Swelling; Severe
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After First Vaccination; Pain: Mild
|
16.9 percentage of participants
|
23.4 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After First Vaccination; Pain: Moderate
|
2.2 percentage of participants
|
3.9 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After First Vaccination; Pain: Severe
|
0.3 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After First Vaccination; Erythema; Moderate
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After First Vaccination; Erythema; Severe
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After First Vaccination; Swelling; Mild
|
0.4 percentage of participants
|
1.2 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After First Vaccination; Swelling; Moderate
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After First Vaccination; Swelling; Severe
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After Second Vaccination Pain; Mild
|
10.7 percentage of participants
|
19.7 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After Second Vaccination Pain; Moderate
|
1.5 percentage of participants
|
3.2 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After Second Vaccination Pain; Severe
|
0.3 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After Second Vaccination Erythema; Mild
|
0.0898 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After Second Vaccination Erythema; Moderate
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After Second Vaccination Erythema; Severe
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After Second Vaccination Swelling; Mild
|
0.0899 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After Second Vaccination Swelling; Moderate
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After Second Vaccination Swelling; Severe
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After First Vaccination; Pain: Mild
|
19.5 percentage of participants
|
21.1 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After First Vaccination; Pain: Moderate
|
1.2 percentage of participants
|
2.1 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After First Vaccination; Pain: Severe
|
0.6 percentage of participants
|
0.3 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After First Vaccination; Erythema; Mild
|
0.6 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After First Vaccination; Erythema; Moderate
|
0 percentage of participants
|
0.6 percentage of participants
|
SECONDARY outcome
Timeframe: Days 1 through 14 after each vaccination on Day 1 (Month 0) and Day 90 (Month 3)Population: The SS- Immunogenicity Subset included all randomized participants in the safety/immunogenicity subset who received at least 1 dose of the trial vaccines (TDV or placebo). Number analyzed is the number of participants with data available for analysis for the specified category.
Solicited systemic AEs in children (\< 6 years) are defined as fever, irritability/fussiness, drowsiness and loss of appetite that occurred within 14 days after each vaccination. Solicited systemic AEs in children (≥ 6 years) are defined as fever, headache, asthenia, malaise and myalgia that occurred within 14 days after each vaccination. The participant/legal guardian recorded the severity of each AE (except fever) according to the diary card instruction as none, mild, moderate, or severe. Severity grades for fever were derived from the recorded body temperature measurements and presented using the proposed temperature increments published by the Brighton Collaboration. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation.
Outcome measures
| Measure |
Placebo
n=1329 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=2663 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After First Vaccination; Irritability/Fussiness: Mild
|
8.3 percentage of participants
|
7.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After First Vaccination; Irritability/Fussiness: Moderate
|
0.6 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After First Vaccination; Irritability/Fussiness: Severe
|
0 percentage of participants
|
0.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After First Vaccination; Drowsiness; Mild
|
10.1 percentage of participants
|
8.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After First Vaccination; Drowsiness; Moderate
|
0 percentage of participants
|
2.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After First Vaccination; Drowsiness; Severe
|
0 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After First Vaccination; Loss of Appetite; Mild
|
7.1 percentage of participants
|
12.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After First Vaccination; Loss of Appetite; Moderate
|
1.8 percentage of participants
|
1.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After First Vaccination; Loss of Appetite; Severe
|
0.6 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After First Vaccination; Fever; 38.0-<38.5
|
3.3 percentage of participants
|
3.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After First Vaccination; Fever; 38.5-<39.0
|
2.0 percentage of participants
|
1.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After First Vaccination; Fever; 39.0-<39.5
|
2.0 percentage of participants
|
1.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After First Vaccination; Fever; 39.5-<40.0
|
0.7 percentage of participants
|
1.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After First Vaccination; Fever: >=40.0
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After Second Vaccination; Irritability/Fussiness: Mild
|
2.1 percentage of participants
|
5.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After Second Vaccination; Irritability/Fussiness: Moderate
|
0 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After Second Vaccination; Irritability/Fussiness: Severe
|
0 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After Second Vaccination; Drowsiness; Mild
|
4.9 percentage of participants
|
6.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After Second Vaccination; Drowsiness; Moderate
|
0 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After Second Vaccination; Drowsiness; Severe
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After Second Vaccination; Loss of Appetite; Mild
|
4.9 percentage of participants
|
6.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After Second Vaccination; Loss of Appetite; Moderate
|
0.7 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After Second Vaccination; Loss of Appetite; Severe
|
0.7 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After Second Vaccination; Fever: 38.0-<38.5
|
4.4 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After Second Vaccination; Fever: 38.5-<39.0
|
1.3 percentage of participants
|
3.5 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After Second Vaccination; Fever: 39.0-<39.5
|
1.3 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After Second Vaccination; Fever: 39.5-<40.0
|
0 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After Second Vaccination; Fever: 40.0-<40.5
|
0.6 percentage of participants
|
0.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age <6 Years; After Second Vaccination; Fever: >=40.5
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After First Vaccination; Headache: Mild
|
17.8 percentage of participants
|
17.5 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After First Vaccination; Headache: Moderate
|
3.4 percentage of participants
|
5.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After First Vaccination; Headache: Severe
|
1.7 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After First Vaccination; Asthenia: Mild
|
8.8 percentage of participants
|
8.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After First Vaccination; Asthenia: Moderate
|
2.8 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After First Vaccination; Asthenia: Severe
|
0.5 percentage of participants
|
0.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After First Vaccination; Malaise: Mild
|
11.1 percentage of participants
|
11.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After First Vaccination; Malaise: Moderate
|
2.3 percentage of participants
|
3.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After First Vaccination; Malaise: Severe
|
0.8 percentage of participants
|
1.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After First Vaccination; Muscle Pain: Mild
|
11.8 percentage of participants
|
14.1 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After First Vaccination; Muscle Pain: Moderate
|
1.9 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After First Vaccination; Muscle Pain: Severe
|
0.6 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After First Vaccination; Fever: 38.0-<38.5
|
3.0 percentage of participants
|
3.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After First Vaccination; Fever: 38.5-<39.0
|
1.8 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After First Vaccination; Fever: 39.0-<39.5
|
1.0 percentage of participants
|
0.5 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After First Vaccination; Fever: 39.5-<40.0
|
0.4 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After First Vaccination; Fever: 40.0-<40.5
|
0.0951 percentage of participants
|
0.0479 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After First Vaccination; Fever: 40.5-<41.0
|
0.0951 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After First Vaccination; Fever: >=41.0
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After Second Vaccination; Headache: Mild
|
10.2 percentage of participants
|
10.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After Second Vaccination; Headache: Moderate
|
2.9 percentage of participants
|
3.5 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After Second Vaccination; Headache: Severe
|
1.1 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After Second Vaccination; Asthenia: Mild
|
5.6 percentage of participants
|
6.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After Second Vaccination; Asthenia: Moderate
|
1.6 percentage of participants
|
1.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After Second Vaccination; Asthenia: Severe
|
0.4 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After Second Vaccination; Malaise: Mild
|
6.8 percentage of participants
|
8.1 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After Second Vaccination; Malaise: Moderate
|
1.8 percentage of participants
|
1.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After Second Vaccination; Malaise: Severe
|
0.8 percentage of participants
|
1.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After Second Vaccination; Muscle Pain: Mild
|
7.6 percentage of participants
|
10.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After Second Vaccination; Muscle Pain: Moderate
|
1.3 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After Second Vaccination; Muscle Pain: Severe
|
0.4 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After Second Vaccination; Fever: 38.0-<38.5
|
3.4 percentage of participants
|
2.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After Second Vaccination; Fever: 38.5-<39.0
|
1.2 percentage of participants
|
1.5 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After Second Vaccination; Fever: 39.0-<39.5
|
1.1 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After Second Vaccination; Fever: 39.5-<40.0
|
0.4 percentage of participants
|
0.5 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After Second Vaccination; Fever: 40.0-<40.5
|
0 percentage of participants
|
0.0467 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Children of Age >=6 Years; After Second Vaccination; Fever: >=40.5
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Days 1 through 28 after each vaccination on Day 1 (Month 0) and Day 90 (Month 3)Population: The SS-Immunogenicity Subset included all randomized participants in the safety/immunogenicity subset who received at least 1 dose of the trial vaccines (TDV or placebo). Number analyzed is the number of participants with data available for analysis for the specified category.
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study. Percentages were rounded off to the nearest single decimal place.
Outcome measures
| Measure |
Placebo
n=1329 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=2663 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Set Immunogenicity Subset
After First Vaccination
|
11.6 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Set Immunogenicity Subset
After Second Vaccination
|
9.2 percentage of participants
|
9.3 percentage of participants
|
SECONDARY outcome
Timeframe: From Day 1 until the end of Parts 1 (Month 15) and 2 (Month 21)Population: The SS included all randomized participants who received at least one dose of the investigational product (IP) (TDV or placebo). Number analyzed is the number of participants at risk at the start of the specified analysis period.
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Percentages were rounded off to the nearest single decimal place. In the category 'Part 1 and 2 combined' participants are counted only once even if they experienced events in both Part 1 and Part 2 in order to yield total of unique participants who had SAEs.
Outcome measures
| Measure |
Placebo
n=6687 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=13380 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) During Parts 1 and 2
Part 1
|
3.8 percentage of participants
|
3.1 percentage of participants
|
|
Percentage of Participants With Serious Adverse Events (SAEs) During Parts 1 and 2
Part 2
|
1.3 percentage of participants
|
1.2 percentage of participants
|
|
Percentage of Participants With Serious Adverse Events (SAEs) During Parts 1 and 2
Parts 1 and 2 Combined
|
4.9 percentage of participants
|
4.1 percentage of participants
|
SECONDARY outcome
Timeframe: First and Second half (18 months each) of Part 3 (up to 3 years, beginning at Month 22)Population: The SS included all randomized participants who received at least one dose of the IP (TDV or placebo). Overall number of participants analyzed are the number of participants with data available for analyses. Number analyzed is the number of participants at risk at the start of the specified analysis period.
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation.
Outcome measures
| Measure |
Placebo
n=6487 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=12961 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During the First and Second Half of Part 3
Fatal SAEs: First Half of Part 3
|
0.0308 percentage of participants
|
0.0386 percentage of participants
|
|
Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During the First and Second Half of Part 3
SAEs Related to Study Drug: First Half of Part 3
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During the First and Second Half of Part 3
Fatal SAEs: Second Half of Part 3
|
0.0631 percentage of participants
|
0.0474 percentage of participants
|
|
Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During the First and Second Half of Part 3
SAEs Related to Study Drug: Second Half of Part 3
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Pre-vaccination on Day 1 (Baseline), post-first vaccination on Month 1, pre-vaccination on Month 3; post-second vaccination at Months 4, 9 and 15, and then annually (up to 3 years)Population: Per-Protocol Set for Immunogenicity (PPSI): all participants in Full Analysis Set for Immunogenicity (FASI) who had no major protocol violations. The FASI were based on FAS \& included all randomized participants in subset for whom a valid pre-dosing and at least one valid post-dosing blood sample have been received for immunogenicity. Number analyzed is the number of participants with data available for analysis at the specified time point.
Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation.
Outcome measures
| Measure |
Placebo
n=1247 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=2518 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 15: DENV-4
|
66.0 percentage of participants
|
98.4 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Baseline: DENV-1
|
65.5 percentage of participants
|
64.3 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Baseline: DENV-2
|
70.3 percentage of participants
|
69.6 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Baseline: DENV-3
|
63.7 percentage of participants
|
63.5 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Baseline: DENV-4
|
63.2 percentage of participants
|
63.5 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 1: DENV-1
|
65.0 percentage of participants
|
98.0 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 1: DENV-2
|
70.0 percentage of participants
|
99.5 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 1: DENV-3
|
64.0 percentage of participants
|
98.7 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 1: DENV-4
|
62.7 percentage of participants
|
97.1 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 3: DENV-1
|
66.9 percentage of participants
|
97.1 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 3: DENV-2
|
71.2 percentage of participants
|
99.7 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 3: DENV-3
|
63.6 percentage of participants
|
98.1 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 3: DENV-4
|
63.6 percentage of participants
|
97.3 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 4: DENV-1
|
67.6 percentage of participants
|
99.8 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 4: DENV-2
|
71.8 percentage of participants
|
99.912 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 4: DENV-3
|
65.0 percentage of participants
|
99.9 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 4: DENV-4
|
65.2 percentage of participants
|
99.912 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 9: DENV-1
|
67.5 percentage of participants
|
98.3 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 9: DENV-2
|
73.5 percentage of participants
|
100.0 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 9: DENV-3
|
65.2 percentage of participants
|
98.8 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 9: DENV-4
|
65.2 percentage of participants
|
99.0 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 15: DENV-1
|
67.7 percentage of participants
|
97.6 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 15: DENV-2
|
70.4 percentage of participants
|
99.955 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 15: DENV-3
|
64.3 percentage of participants
|
97.7 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Year 1: DENV-1
|
69.6 percentage of participants
|
97.0 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Year 1: DENV-2
|
72.0 percentage of participants
|
99.9 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Year 1: DENV-3
|
67.5 percentage of participants
|
97.3 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Year 1: DENV-4
|
68.6 percentage of participants
|
98.3 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Year 2: DENV-1
|
71.5 percentage of participants
|
95.7 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Year 2: DENV-2
|
73.7 percentage of participants
|
99.948 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Year 2: DENV-3
|
68.8 percentage of participants
|
95.5 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Year 2: DENV-4
|
70.7 percentage of participants
|
98.0 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Year 3: DENV-1
|
72.5 percentage of participants
|
94.9 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Year 3: DENV-2
|
73.5 percentage of participants
|
99.9 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Year 3: DENV-3
|
70.2 percentage of participants
|
95.7 percentage of participants
|
|
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Year 3: DENV-4
|
71.1 percentage of participants
|
96.0 percentage of participants
|
SECONDARY outcome
Timeframe: Pre-vaccination on Day 1 (Baseline), post-first vaccination on Month 1, pre-vaccination on Month 3; post-second vaccination at Months 4, 9 and 15, and then annually (up to 3 years)Population: PPSI: all participants in FASI who had no major protocol violations. The FASI were based on FAS \& included all randomized participants in subset for whom a valid pre-dosing and at least one valid post-dosing blood sample have been received for immunogenicity. Number analyzed is the number of participants with data available for analysis at the specified time point.
Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for any one (monovalent), two (bivalent), three (trivalent), and four (tetravalent) dengue serotypes, as well as at least bivalent (seropositive for ≥2 dengue serotypes) and at least trivalent (seropositive for ≥3 dengue serotypes), is derived from the titers of dengue-neutralizing antibodies. Seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation.
Outcome measures
| Measure |
Placebo
n=1247 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=2518 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 15: Trivalent
|
2.1 percentage of participants
|
2.2 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Baseline: Monovalent
|
5.5 percentage of participants
|
6.6 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Baseline: Bivalent
|
3.8 percentage of participants
|
2.4 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Baseline: Trivalent
|
2.7 percentage of participants
|
2.9 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Baseline: Tetravalent
|
60.4 percentage of participants
|
60.2 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Baseline: At Least Bivalent
|
66.9 percentage of participants
|
65.5 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 3: Bivalent
|
3.1 percentage of participants
|
1.1 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Baseline: At Least Trivalent
|
63.1 percentage of participants
|
63.1 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 1: Monovalent
|
7.4 percentage of participants
|
0.3 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 1: Bivalent
|
2.8 percentage of participants
|
0.6 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 1: Trivalent
|
3.2 percentage of participants
|
3.7 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 1: Tetravalent
|
59.8 percentage of participants
|
95.2 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 1: At Least Bivalent
|
65.8 percentage of participants
|
99.4 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 1: At Least Trivalent
|
63.0 percentage of participants
|
98.9 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 3: Monovalent
|
6.8 percentage of participants
|
0.4 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 3: Trivalent
|
3.1 percentage of participants
|
3.7 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 3: Tetravalent
|
60.8 percentage of participants
|
94.6 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 3: At Least Bivalent
|
67.0 percentage of participants
|
99.4 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 3: At Least Trivalent
|
63.8 percentage of participants
|
98.3 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 4: Monovalent
|
6.6 percentage of participants
|
0 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 4: Bivalent
|
2.6 percentage of participants
|
0.088 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 4: Trivalent
|
2.5 percentage of participants
|
0.1 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 4: Tetravalent
|
62.6 percentage of participants
|
99.7 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 4: At Least Bivalent
|
67.6 percentage of participants
|
99.956 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 4: At Least Trivalent
|
65.1 percentage of participants
|
99.9 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 9: Monovalent
|
7.7 percentage of participants
|
0.091 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 9: Bivalent
|
3.4 percentage of participants
|
0.8 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 9: Trivalent
|
2.0 percentage of participants
|
2.1 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 9: Tetravalent
|
62.7 percentage of participants
|
97.0 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 9: At Least Bivalent
|
68.1 percentage of participants
|
99.909 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 9: At Least Trivalent
|
64.7 percentage of participants
|
99.1 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 15: Monovalent
|
3.9 percentage of participants
|
0.5 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 15: Bivalent
|
3.6 percentage of participants
|
1.4 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 15: Tetravalent
|
62.8 percentage of participants
|
96.0 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 15: At Least Bivalent
|
68.4 percentage of participants
|
99.5 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Month 15: At Least Trivalent
|
64.8 percentage of participants
|
98.1 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Year 1: Monovalent
|
3.5 percentage of participants
|
0.7 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Year 1: Bivalent
|
1.9 percentage of participants
|
1.5 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Year 1: Trivalent
|
2.2 percentage of participants
|
2.2 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Year 1: Tetravalent
|
65.9 percentage of participants
|
95.5 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Year 1: At Least Bivalent
|
70.1 percentage of participants
|
99.3 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Year 1: At Least Trivalent
|
68.2 percentage of participants
|
97.7 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Year 2: Monovalent
|
2.9 percentage of participants
|
1.1 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Year 2: Bivalent
|
2.5 percentage of participants
|
1.9 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Year 2: Trivalent
|
1.8 percentage of participants
|
3.7 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Year 2: Tetravalent
|
67.9 percentage of participants
|
93.3 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Year 2: At Least Bivalent
|
72.1 percentage of participants
|
98.9 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Year 2: At Least Trivalent
|
69.6 percentage of participants
|
97.0 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Year 3:Monovalent
|
2.6 percentage of participants
|
1.6 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Year 3: Bivalent
|
1.9 percentage of participants
|
2.4 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Year 3:Trivalent
|
2.5 percentage of participants
|
3.7 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Year 3:Tetravalent
|
68.3 percentage of participants
|
92.3 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Year 3:At Least Bivalent
|
72.7 percentage of participants
|
98.3 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Year 3:At Least Trivalent
|
70.9 percentage of participants
|
95.9 percentage of participants
|
SECONDARY outcome
Timeframe: Pre-vaccination on Day 1 (Baseline), post-first vaccination on Month 1, pre-vaccination on Month 3; post-second vaccination at Months 4, 9 and 15, and then annually (up to 3 years)Population: PPSI: all participants in FASI who had no major protocol violations. The FASI were based on FAS \& included all randomized participants in subset for whom a valid pre-dosing and at least one valid post-dosing blood sample have been received for immunogenicity. Number analyzed is the number of participants with data available for analysis at the specified time point.
GMTs of neutralizing antibodies were measured via microneutralization test 50% (MNT50). The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Outcome measures
| Measure |
Placebo
n=1247 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=2518 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
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|---|---|---|
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Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 9: DENV-1
|
130.5 titres
Interval 110.3 to 154.4
|
666.6 titres
Interval 611.8 to 726.2
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 9: DENV-2
|
225.7 titres
Interval 190.5 to 267.3
|
2521.0 titres
Interval 2392.4 to 2656.5
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 9: DENV-3
|
105.3 titres
Interval 89.9 to 123.3
|
513.0 titres
Interval 474.2 to 555.1
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 9: DENV-4
|
84.4 titres
Interval 72.9 to 97.8
|
390.0 titres
Interval 363.6 to 418.4
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 15: DENV-1
|
139.2 titres
Interval 117.6 to 164.7
|
584.1 titres
Interval 534.9 to 637.8
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 15: DENV-2
|
211.8 titres
Interval 178.5 to 251.3
|
1977.3 titres
Interval 1871.7 to 2088.8
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 15: DENV-3
|
97.3 titres
Interval 83.3 to 113.5
|
383.9 titres
Interval 354.0 to 416.3
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 15: DENV-4
|
99.9 titres
Interval 86.0 to 116.0
|
408.0 titres
Interval 379.6 to 438.6
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Year 1: DENV-1
|
161.3 titres
Interval 134.6 to 193.3
|
567.8 titres
Interval 516.0 to 624.7
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Year 1: DENV-2
|
183.1 titres
Interval 154.0 to 217.7
|
1123.9 titres
Interval 1054.1 to 1198.3
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Year 1: DENV-3
|
111.0 titres
Interval 94.1 to 130.9
|
377.7 titres
Interval 346.2 to 412.2
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Year 1: DENV-4
|
98.6 titres
Interval 84.6 to 115.0
|
345.0 titres
Interval 319.6 to 372.5
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Year 2: DENV-1
|
205.1 titres
Interval 170.9 to 246.1
|
513.2 titres
Interval 465.9 to 565.3
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Year 2: DENV-2
|
208.1 titres
Interval 175.3 to 246.9
|
896.4 titres
Interval 839.2 to 957.5
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Year 2: DENV-3
|
127.5 titres
Interval 108.2 to 150.2
|
323.2 titres
Interval 295.7 to 353.2
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Year 2: DENV-4
|
110.4 titres
Interval 94.8 to 128.4
|
283.8 titres
Interval 262.9 to 306.4
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Year 3: DENV-1
|
213.3 titres
Interval 179.4 to 253.6
|
483.1 titres
Interval 440.7 to 529.7
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Year 3: DENV-2
|
193.6 titres
Interval 164.6 to 227.6
|
727.5 titres
Interval 682.4 to 775.5
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Year 3: DENV-3
|
139.8 titres
Interval 119.3 to 163.7
|
327.9 titres
Interval 301.4 to 356.8
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Year 3: DENV-4
|
107.6 titres
Interval 93.1 to 124.4
|
244.4 titres
Interval 226.7 to 263.6
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 3: DENV-1
|
126.3 titres
Interval 107.9 to 148.0
|
828.7 titres
Interval 760.6 to 902.8
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 3: DENV-2
|
201.0 titres
Interval 171.3 to 236.0
|
3598.5 titres
Interval 3425.0 to 3780.8
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 3: DENV-3
|
103.9 titres
Interval 89.5 to 120.7
|
714.2 titres
Interval 661.1 to 771.6
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 3: DENV-4
|
77.8 titres
Interval 67.8 to 89.3
|
463.9 titres
Interval 431.3 to 498.9
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 4: DENV-1
|
139.0 titres
Interval 117.6 to 164.3
|
1059.2 titres
Interval 981.6 to 1143.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 4: DENV-2
|
215.3 titres
Interval 181.7 to 255.0
|
3646.7 titres
Interval 3480.0 to 3821.3
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 4: DENV-3
|
114.5 titres
Interval 97.7 to 134.3
|
986.7 titres
Interval 924.5 to 1053.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 4: DENV-4
|
86.2 titres
Interval 74.5 to 99.8
|
630.0 titres
Interval 593.2 to 668.9
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 1: DENV-4
|
77.6 titres
Interval 67.2 to 89.7
|
653.4 titres
Interval 607.0 to 703.4
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Baseline: DENV-1
|
128.6 titres
Interval 109.3 to 151.4
|
120.3 titres
Interval 107.3 to 134.8
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Baseline: DENV-2
|
197.4 titres
Interval 167.8 to 232.2
|
186.0 titres
Interval 165.9 to 208.4
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Baseline: DENV-3
|
109.4 titres
Interval 93.8 to 127.6
|
108.7 titres
Interval 97.6 to 121.1
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Baseline: DENV-4
|
80.8 titres
Interval 70.2 to 93.1
|
76.2 titres
Interval 69.2 to 83.9
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 1: DENV-1
|
127.5 titres
Interval 107.7 to 150.9
|
1031.5 titres
Interval 944.4 to 1126.6
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 1: DENV-2
|
197.2 titres
Interval 166.7 to 233.4
|
6575.7 titres
Interval 6237.2 to 6932.5
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Month 1: DENV-3
|
108.6 titres
Interval 92.8 to 127.1
|
1133.8 titres
Interval 1050.4 to 1223.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: First half of Part 3 (18 months beginning at Month 22)Population: PPS included all participants in the FAS who had no major protocol violations. FAS included all randomized participants who received at least 1 dose of the trial vaccines. Overall number of participants analyzed is the number of participants with data available for analyses.
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases due to virologically-confirmed dengue fever that occurred during the first half of Part 3.
Outcome measures
| Measure |
Placebo
n=6236 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=12510 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype
|
228 number of cases
|
252 number of cases
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Second half of Part 3 (18 months beginning at Month 40)Population: PPS included all participants in the FAS who had no major protocol violations. FAS included all randomized participants who received at least 1 dose of the trial vaccines. Overall number of participants analyzed is the number of participants with data available for analyses.
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases due to virologically-confirmed dengue fever that occurred during the second half of Part 3.
Outcome measures
| Measure |
Placebo
n=6102 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=12224 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype
|
52 number of cases
|
49 number of cases
|
OTHER_PRE_SPECIFIED outcome
Timeframe: First half of Part 3 (18 months beginning at Month 22)Population: PPS included all participants in the FAS who had no major protocol violations. FAS included all randomized participants who received at least 1 dose of the trial vaccines. Overall number of participants analyzed is the number of participants with data available for analyses.
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases requiring hospitalization due to virologically-confirmed dengue fever that occurred during the first half of Part 3.
Outcome measures
| Measure |
Placebo
n=6236 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=12510 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype
|
43 number of cases
|
24 number of cases
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Second half of Part 3 (18 months beginning at Month 40)Population: PPS included all participants in the FAS who had no major protocol violations. FAS included all randomized participants who received at least 1 dose of the trial vaccines. Overall number of participants analyzed is the number of participants with data available for analyses.
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases requiring hospitalization due to virologically-confirmed dengue fever that occurred during the second half of Part 3.
Outcome measures
| Measure |
Placebo
n=6102 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=12224 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype
|
15 number of cases
|
2 number of cases
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From 30 days post-booster vaccination (Day 30 booster [b] (Month 1b)) until the end of Part 4 (Month 13b)Population: The Per-Protocol Set-Booster (PPS-B) included all participants in the FAS-B who had no major protocol violations. The Full Analysis Set-Booster (FAS-B) included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
The VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases.
Outcome measures
| Measure |
Placebo
n=2981 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=5966 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
VE of a TDV Booster Dose in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30 Booster [b] (Month 1b)) Until the End of Part 4
|
93 number of cases
|
39 number of cases
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 4 (Month 13b)Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases.
Outcome measures
| Measure |
Placebo
n=2981 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=5966 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4
DENV-1
|
32 number of cases
|
15 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4
DENV-2
|
31 number of cases
|
9 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4
DENV-3
|
4 number of cases
|
3 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4
DENV-4
|
26 number of cases
|
12 number of cases
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 4 (Month 13b)Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo). Overall number of participants analyzed is the number of participants with seronegative baseline status and with data available for analyses.
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. Participants are counted only once for the "Any Dengue Serotype" category but counted separately for each dengue serotype they belong to.
Outcome measures
| Measure |
Placebo
n=986 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=1928 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4
Any Dengue Serotype
|
26 number of cases
|
11 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4
DENV-1
|
14 number of cases
|
4 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4
DENV-2
|
5 number of cases
|
1 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4
DENV-3
|
2 number of cases
|
2 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4
DENV-4
|
5 number of cases
|
4 number of cases
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 4 (Month 13b)Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo). Overall number of participants analyzed is the number of participants with seropositive baseline status and with data available for analyses.
VE is defined as 1 - (λv/λC), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. Participants are counted only once for the "Any Dengue Serotype" category but counted separately for each dengue serotype they belong to.
Outcome measures
| Measure |
Placebo
n=1995 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=4036 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4
Any Dengue Serotype
|
67 number of cases
|
28 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4
DENV-1
|
18 number of cases
|
11 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4
DENV-2
|
26 number of cases
|
8 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4
DENV-3
|
2 number of cases
|
1 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4
DENV-4
|
21 number of cases
|
8 number of cases
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 4 (Month 13b)Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases requiring hospitalization due to virologically-confirmed dengue fever.
Outcome measures
| Measure |
Placebo
n=2981 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=5966 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
VE of a TDV Booster Dose in Preventing Hospitalization Due to Virologically Confirmed Dengue Fever Induced by Any Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4
|
24 number of cases
|
3 number of cases
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 4 (Month 13b)Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. Severe cases were determined by Adjudication Committee. VE was assessed using the number of severe cases due to virologically-confirmed dengue fever.
Outcome measures
| Measure |
Placebo
n=2981 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=5966 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Severe Dengue Fever Induced by Any Dengue Serotype From 30 Days Post-Booster Vaccination (Day 30b [Month 1b]) Until the End of Part 4
|
1 number of cases
|
0 number of cases
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Month 14b until the end of Part 5 (Month 25b)Population: The Per-Protocol Set-Booster (PPS-B) included all participants in the FAS-B who had no major protocol violations. The Full Analysis Set-Booster (FAS-B) included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
The VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. Participants are counted only once for the any dengue serotype.
Outcome measures
| Measure |
Placebo
n=2935 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=5865 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
VE of a TDV Booster Dose in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype During Part 5
|
66 number of cases
|
45 number of cases
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Month 14b until the end of Part 5 (Month 25b)Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. Participants are counted separately for each dengue serotype.
Outcome measures
| Measure |
Placebo
n=2935 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=5865 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype During Part 5
DENV-1
|
19 number of cases
|
17 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype During Part 5
DENV-2
|
18 number of cases
|
5 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype During Part 5
DENV-3
|
20 number of cases
|
20 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype During Part 5
DENV-4
|
10 number of cases
|
3 number of cases
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Month 14b until the end of Part 5 (Month 25b)Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo). Overall number of participants analyzed is the number of participants with seronegative baseline status and with data available for analyses.
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. Participants are counted only once for the "Any Dengue Serotype" category but counted separately for each dengue serotype they belong to.
Outcome measures
| Measure |
Placebo
n=974 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=1908 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline During Part 5
Any Dengue Serotype
|
20 number of cases
|
12 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline During Part 5
DENV-1
|
7 number of cases
|
6 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline During Part 5
DENV-2
|
5 number of cases
|
1 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline During Part 5
DENV-3
|
4 number of cases
|
5 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline During Part 5
DENV-4
|
4 number of cases
|
0 number of cases
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Month 14b until the end of Part 5 (Month 25b)Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo). Overall number of participants analyzed is the number of participants with seropositive baseline status and with data available for analyses.
VE is defined as 1 - (λv/λC), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. Participants are counted only once for the "Any Dengue Serotype" category but counted separately for each dengue serotype they belong to.
Outcome measures
| Measure |
Placebo
n=1961 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=3955 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline During Part 5
Any Dengue Serotype
|
46 number of cases
|
33 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline During Part 5
DENV-3
|
16 number of cases
|
15 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline During Part 5
DENV-1
|
12 number of cases
|
11 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline During Part 5
DENV-2
|
13 number of cases
|
4 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline During Part 5
DENV-4
|
6 number of cases
|
3 number of cases
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Month 14b until the end of Part 5 (Month 25b)Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases requiring hospitalization due to virologically-confirmed dengue fever.
Outcome measures
| Measure |
Placebo
n=2935 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=5865 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
VE of a TDV Booster Dose in Preventing Hospitalization Due to Virologically Confirmed Dengue Fever Induced by Any Dengue Serotype During Part 5
|
13 number of cases
|
4 number of cases
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Month 14b until the end of Part 5 (Month 25b)Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. Severe cases were determined by Adjudication Committee. VE was assessed using the number of severe cases due to virologically-confirmed dengue fever.
Outcome measures
| Measure |
Placebo
n=2935 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=5865 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Severe Dengue Fever Induced by Any Dengue Serotype During Part 5
|
0 number of cases
|
0 number of cases
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From 30 days post-booster vaccination (Day 30b [Month 1b) until the end of Part 5 (Month 25b)Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
The VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases.
Outcome measures
| Measure |
Placebo
n=2981 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=5966 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
VE of a TDV Booster Dose in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype for Parts 4 And 5 Combined
|
159 number of cases
|
84 number of cases
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 5 (Month 25b)Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases.
Outcome measures
| Measure |
Placebo
n=2981 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=5966 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype for Parts 4 And 5 Combined
DENV-3
|
25 number of cases
|
23 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype for Parts 4 And 5 Combined
DENV-2
|
49 number of cases
|
14 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype for Parts 4 And 5 Combined
DENV-1
|
51 number of cases
|
32 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Each Dengue Serotype for Parts 4 And 5 Combined
DENV-4
|
36 number of cases
|
15 number of cases
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 5 (Month 25b)Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo). Overall number of participants analyzed is the number of participants with seronegative baseline status and with data available for analyses.
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. Participants are counted only once for the "Any Dengue Serotype" category but counted separately for each dengue serotype they belong to.
Outcome measures
| Measure |
Placebo
n=986 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=1928 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline for Parts 4 And 5 Combined
DENV-4
|
9 number of cases
|
4 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline for Parts 4 And 5 Combined
Any Dengue Serotype
|
46 number of cases
|
23 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline for Parts 4 And 5 Combined
DENV-1
|
21 number of cases
|
10 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline for Parts 4 And 5 Combined
DENV-2
|
10 number of cases
|
2 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any And Each Dengue Serotype in Dengue Seronegative Participants at Baseline for Parts 4 And 5 Combined
DENV-3
|
6 number of cases
|
7 number of cases
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 5 (Month 25b)Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo). Overall number of participants analyzed is the number of participants with seropositive baseline status and with data available for analyses.
VE is defined as 1 - (λv/λC), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases. Participants are counted only once for the "Any Dengue Serotype" category but counted separately for each dengue serotype they belong to.
Outcome measures
| Measure |
Placebo
n=1995 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=4036 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline for Parts 4 And 5 Combined
DENV-1
|
30 number of cases
|
22 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline for Parts 4 And 5 Combined
Any Dengue Serotype
|
113 number of cases
|
61 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline for Parts 4 And 5 Combined
DENV-2
|
39 number of cases
|
12 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline for Parts 4 And 5 Combined
DENV-3
|
19 number of cases
|
16 number of cases
|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Dengue Fever Induced by Any and Each Dengue Serotype in Dengue Seropositive Participants at Baseline for Parts 4 And 5 Combined
DENV-4
|
27 number of cases
|
11 number of cases
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 5 (Month 25b)Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases requiring hospitalization due to virologically-confirmed dengue fever.
Outcome measures
| Measure |
Placebo
n=2981 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=5966 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
VE of a TDV Booster Dose in Preventing Hospitalization Due to Virologically Confirmed Dengue Fever Induced by Any Dengue Serotype for Parts 4 And 5 Combined
|
37 number of cases
|
7 number of cases
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From 30 days post-booster vaccination (Day 30b [Month 1b]) until the end of Part 5 (Month 25b)Population: The PPS-B included all participants in the FAS-B who had no major protocol violations. The FAS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo).
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. Severe cases were determined by Adjudication Committee. VE was assessed using the number of severe cases due to virologically-confirmed dengue fever.
Outcome measures
| Measure |
Placebo
n=2981 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=5966 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
VE of a TDV Booster Dose in Preventing Virologically Confirmed Severe Dengue Fever Induced by Any Dengue Serotype for Parts 4 And 5 Combined
|
1 number of cases
|
0 number of cases
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1b through 7b after booster vaccination in Part 4Population: Safety Set-Booster-Immunogenicity Subset included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo) in the safety subset. Number analyzed is the number of participants with data available for analyses for the specified category.
Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred within 7 days after each vaccination. The participant/legal guardian recorded the severity of each AE (except erythema and swelling) according to the diary card instruction as none, mild, moderate, or severe. Severity grades for erythema and swelling were derived from the recorded diameters. Percentages were rounded off to the nearest single decimal place.
Outcome measures
| Measure |
Placebo
n=600 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=1200 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Swelling: Mild
|
0.5 percentage of participants
|
1.0 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Swelling: Severe
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Pain: Mild
|
12.1 percentage of participants
|
20.1 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Pain: Moderate
|
3.9 percentage of participants
|
4.6 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Pain: Severe
|
0.7 percentage of participants
|
1.2 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Erythema: Mild
|
0.2 percentage of participants
|
1.6 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Erythema: Moderate
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Erythema: Severe
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Swelling: Moderate
|
0 percentage of participants
|
0 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1b through 14b after booster vaccination in Part 4Population: Safety Set-Booster-Immunogenicity Subset included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo) in the safety subset. Number analyzed is the number of participants with data available for analyses for the specified category.
Solicited systemic AEs are defined as fever, headache, asthenia, malaise and myalgia that occurred within 14 days after each vaccination. The participant/legal guardian recorded the severity of each AE (except fever) according to the diary card instruction as none, mild, moderate, or severe. Severity grades for fever were derived from the recorded body temperature measurements and presented using the proposed temperature increments published by the Brighton Collaboration. Percentages were rounded off to the nearest single decimal place except the data point where rounding-up may lead to data misinterpretation.
Outcome measures
| Measure |
Placebo
n=600 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=1200 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Headache: Mild
|
8.6 percentage of participants
|
12.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Headache: Moderate
|
4.7 percentage of participants
|
3.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Headache: Severe
|
0.5 percentage of participants
|
1.1 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Asthenia: Mild
|
7.1 percentage of participants
|
7.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Asthenia: Moderate
|
1.9 percentage of participants
|
2.4 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Asthenia: Severe
|
0.3 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Malaise: Mild
|
7.6 percentage of participants
|
8.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Malaise: Moderate
|
2.0 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Malaise: Severe
|
0.5 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Myalgia: Mild
|
9.9 percentage of participants
|
11.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Myalgia: Moderate
|
1.5 percentage of participants
|
3.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Myalgia: Severe
|
1.0 percentage of participants
|
0.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Fever: 38.0-<38.5
|
1.0 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Fever: 38.5-<39.0
|
0.5 percentage of participants
|
1.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Fever: 39.0-<39.5
|
0.2 percentage of participants
|
0.2 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Fever: 39.5-<40.0
|
0 percentage of participants
|
0.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Fever: 40.0-<40.5
|
0.2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Fever: 40.5-<41.0
|
0 percentage of participants
|
0.0873 percentage of participants
|
|
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set-Booster-Immunogenicity Subset During Part 4
Fever: >=41.0
|
0 percentage of participants
|
0 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1b through 28b after booster vaccination in Part 4Population: Safety Set-Booster-Immunogenicity Subset included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo) in the safety subset.
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study. Percentages were rounded off to the nearest single decimal place.
Outcome measures
| Measure |
Placebo
n=600 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=1200 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Set-Booster-Immunogenicity Subset During Part 4
|
1.8 percentage of participants
|
1.8 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Day 1b until the end of Part 4 (Month 13b) and Part 5 (Month 25b)Population: Safety Set-Booster (SS-B) included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo). Number analyzed is the number of participants at risk at the start of the specified analysis period.
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Percentages were rounded off to the nearest single decimal place. In the category 'Part 4 and 5 combined' participants are counted only once even if they experienced events in both Part 4 and Part 5 in order to yield total of unique participants who had SAEs.
Outcome measures
| Measure |
Placebo
n=2985 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=5990 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) During Parts 4 and 5
Part 4
|
4.2 percentage of participants
|
2.7 percentage of participants
|
|
Percentage of Participants With Serious Adverse Events (SAEs) During Parts 4 and 5
Part 5
|
2.5 percentage of participants
|
1.9 percentage of participants
|
|
Percentage of Participants With Serious Adverse Events (SAEs) During Parts 4 and 5
Parts 4 and 5 Combined
|
6.4 percentage of participants
|
4.4 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Day 1b until the end of Part 4 (Month 13b) and Part 5 (Month 25b)Population: SS-B included all participants 4 to 11 years of age at the time of randomization in the trial (Day 1 \[Month 0\]) who were included in the PPS and who received the booster dose of trial vaccine (TDV or placebo). Number analyzed is the number of participants at risk at the start of the specified analysis period.
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation. In the category 'Part 4 and 5 combined' participants are counted only once even if they experienced events in both Part 4 and Part 5 in order to yield total of unique participants who had SAEs.
Outcome measures
| Measure |
Placebo
n=2985 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=5990 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During Parts 4 and 5
Parts 4&5 Combined: Fatal SAEs
|
0.0335 percentage of participants
|
0.1 percentage of participants
|
|
Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During Parts 4 and 5
Parts 4&5 Combined: SAEs Related to Study Drug
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During Parts 4 and 5
Part 4: Fatal SAEs
|
0.0335 percentage of participants
|
0.0501 percentage of participants
|
|
Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During Parts 4 and 5
Part 4: SAEs Related to Study Drug
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During Parts 4 and 5
Part 5: Fatal SAEs
|
0 percentage of participants
|
0.0509 percentage of participants
|
|
Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During Parts 4 and 5
Part 5: SAEs Related to Study Drug
|
0 percentage of participants
|
0 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-booster Vaccination on Day 1b (Month 0b) and post-booster vaccination on Day 30b (Month 1b), Day 180b (Month 6b), Day 395b (Month 13b) and Day 760b (Month 25b) in Parts 4 and 5Population: Per-Protocol Set for Immunogenicity-Booster (PPSI-B):all participants in Full Analysis Set for Immunogenicity-Booster (FASI-B) who had no major protocol violations. FASI-B: all participants from FAS-B who were included in booster immunogenicity subset \& for whom there is valid pre-booster measurement \& at least 1 valid post-booster measurement for immunogenicity assessments. Number analyzed: participants with data available for analyses for the specified category.
Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation.
Outcome measures
| Measure |
Placebo
n=597 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=1186 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5
Day 1b: DENV-1
|
70.2 percentage of participants
|
94.4 percentage of participants
|
|
Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5
Month 1b: DENV-2
|
74.5 percentage of participants
|
99.907 percentage of participants
|
|
Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5
Day 1b: DENV-2
|
72.5 percentage of participants
|
99.2 percentage of participants
|
|
Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5
Day 1b: DENV-3
|
69.0 percentage of participants
|
97.0 percentage of participants
|
|
Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5
Day 1b: DENV-4
|
67.0 percentage of participants
|
93.4 percentage of participants
|
|
Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5
Month 1b: DENV-1
|
71.6 percentage of participants
|
99.907 percentage of participants
|
|
Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5
Month 1b: DENV-3
|
72.9 percentage of participants
|
100.0 percentage of participants
|
|
Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5
Month 1b: DENV-4
|
69.2 percentage of participants
|
99.7 percentage of participants
|
|
Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5
Month 6b: DENV-1
|
72.8 percentage of participants
|
99.7 percentage of participants
|
|
Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5
Month 6b: DENV-2
|
75.8 percentage of participants
|
99.8 percentage of participants
|
|
Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5
Month 6b: DENV-3
|
73.0 percentage of participants
|
99.6 percentage of participants
|
|
Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5
Month 6b: DENV-4
|
70.3 percentage of participants
|
99.7 percentage of participants
|
|
Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5
Month 13b: DENV-1
|
74.5 percentage of participants
|
99.911 percentage of participants
|
|
Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5
Month 13b: DENV-2
|
77.4 percentage of participants
|
99.5 percentage of participants
|
|
Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5
Month 13b: DENV-3
|
74.9 percentage of participants
|
100.0 percentage of participants
|
|
Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5
Month 13b: DENV-4
|
72.4 percentage of participants
|
99.8 percentage of participants
|
|
Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5
Month 25b: DENV-1
|
77.2 percentage of participants
|
99.6 percentage of participants
|
|
Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5
Month 25b: DENV-2
|
78.6 percentage of participants
|
99.8 percentage of participants
|
|
Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5
Month 25b: DENV-3
|
77.7 percentage of participants
|
99.909 percentage of participants
|
|
Seropositivity Rate for Each of The 4 Dengue Serotypes During Parts 4 and 5
Month 25b: DENV-4
|
76.3 percentage of participants
|
99.8 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-booster vaccination on Day 1b (Month 0b) and post-booster vaccination on Day 30b (Month 1b), Day 180b (Month 6b), Day 395b (Month 13b) and Day 760b (Month 25b) in Parts 4 and 5Population: PPSI-B: all participants in FASI-B who had no major protocol violations. FASI-B: all participants from FAS-B who were included in booster immunogenicity subset \& for whom there is valid pre-booster measurement \& at least 1 valid post-booster measurement for immunogenicity assessments. Number analyzed: number of participants with data available for analyses for specified category.
Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for any one (monovalent), two (bivalent), three (trivalent), and four (tetravalent) dengue serotypes, as well as at least bivalent (seropositive for ≥2 dengue serotypes) and at least trivalent (seropositive for ≥3 dengue serotypes), is derived from the titers of dengue-neutralizing antibodies. Seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation.
Outcome measures
| Measure |
Placebo
n=597 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=1186 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Day 1b: Monovalent
|
5.7 percentage of participants
|
1.3 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Day 1b: Bivalent
|
2.0 percentage of participants
|
3.7 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Month 13b: Trivalent
|
2.7 percentage of participants
|
0.8 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Day 1b: Trivalent
|
2.3 percentage of participants
|
4.6 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Day 1b: Tetravalent
|
65.5 percentage of participants
|
90.4 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Day 1b: At Least Bivalent
|
69.8 percentage of participants
|
98.7 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Day 1b: At Least Trivalent
|
67.8 percentage of participants
|
95.0 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Month 1b: Monovalent
|
6.6 percentage of participants
|
0 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Month 1b: Bivalent
|
2.0 percentage of participants
|
0 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Month 1b: Trivalent
|
3.7 percentage of participants
|
0.5 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Month 1b: Tetravalent
|
66.6 percentage of participants
|
99.5 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Month 1b:At Least Bivalent
|
72.3 percentage of participants
|
100.0 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Month 1b:At Least Trivalent
|
70.3 percentage of participants
|
100.0 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Month 6b:Monovalent
|
6.8 percentage of participants
|
0.0887 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Month 6b: Bivalent
|
2.5 percentage of participants
|
0.0887 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Month 6b: Trivalent
|
3.2 percentage of participants
|
0.6 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Month 6b: Tetravalent
|
67.6 percentage of participants
|
99.2 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Month 6b:At Least Bivalent
|
73.3 percentage of participants
|
99.911 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Month 6b:At Least Trivalent
|
70.8 percentage of participants
|
99.8 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Month 13b: Monovalent
|
6.6 percentage of participants
|
0 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Month 13b: Bivalent
|
2.1 percentage of participants
|
0 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Month 13b: Tetravalent
|
70.1 percentage of participants
|
99.2 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Month 13b: At Least Bivalent
|
74.9 percentage of participants
|
100.0 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Month 13b: At Least Trivalent
|
72.7 percentage of participants
|
100.0 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Month 25b: Monovalent
|
3.4 percentage of participants
|
0 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Month 25b: Bivalent
|
1.8 percentage of participants
|
0.0907 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Month 25b: Trivalent
|
1.6 percentage of participants
|
0.4 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Month 25b: Tetravalent
|
74.5 percentage of participants
|
99.5 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Month 25b: At Least Bivalent
|
77.9 percentage of participants
|
99.909 percentage of participants
|
|
Seropositivity Rate for Multiple Dengue Serotypes During Parts 4 and 5
Month 25b: At Least Trivalent
|
76.1 percentage of participants
|
99.8 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-booster Vaccination on Day 1b (Month 0b) and post-booster vaccination on Day 30b (Month 1b), Day 180b (Month 6b), Day 395b (Month 13b) and Day 760b (Month 25b) in Parts 4 and 5Population: PPSI-B: all participants in FASI-B who had no major protocol violations. FASI-B: all participants from FAS-B who were included in booster immunogenicity subset \& for whom there is valid pre-booster measurement \& at least 1 valid post-booster measurement for immunogenicity assessments. Number analyzed: number of participants with data available for analyses for specified category.
GMTs of neutralizing antibodies were measured via MNT50. The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Outcome measures
| Measure |
Placebo
n=597 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=1186 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5
Day 1b: DENV-3
|
129.4 titres
Interval 105.0 to 159.4
|
305.2 titres
Interval 274.6 to 339.3
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5
Month 13b: DENV-1
|
259.3 titres
Interval 204.8 to 328.4
|
949.1 titres
Interval 862.2 to 1044.7
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5
Month 13b: DENV-2
|
248.9 titres
Interval 199.4 to 310.6
|
1003.2 titres
Interval 920.1 to 1093.9
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5
Month 13b: DENV-3
|
199.1 titres
Interval 159.9 to 248.0
|
804.1 titres
Interval 739.2 to 874.8
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5
Month 13b: DENV-4
|
115.0 titres
Interval 94.4 to 140.0
|
433.1 titres
Interval 401.2 to 467.6
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5
Month 25b: DENV-1
|
293.8 titres
Interval 233.1 to 370.3
|
865.6 titres
Interval 782.7 to 957.2
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5
Month 25b: DENV-2
|
278.5 titres
Interval 224.3 to 345.8
|
951.6 titres
Interval 873.0 to 1037.2
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5
Month 25b: DENV-3
|
229.7 titres
Interval 185.5 to 284.3
|
688.3 titres
Interval 632.2 to 749.3
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5
Month 25b: DENV-4
|
129.2 titres
Interval 106.8 to 156.3
|
387.9 titres
Interval 358.6 to 419.6
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5
Month 6b: DENV-3
|
156.0 titres
Interval 126.1 to 192.9
|
851.0 titres
Interval 788.9 to 917.9
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5
Month 6b: DENV-4
|
86.4 titres
Interval 71.9 to 103.9
|
457.6 titres
Interval 427.4 to 490.0
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5
Month 6b: DENV-2
|
208.0 titres
Interval 167.6 to 258.0
|
1167.2 titres
Interval 1080.8 to 1260.5
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5
Day 1b: DENV-1
|
172.7 titres
Interval 137.8 to 216.5
|
374.7 titres
Interval 332.7 to 422.1
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5
Day 1b: DENV-2
|
164.5 titres
Interval 133.2 to 203.2
|
609.4 titres
Interval 558.6 to 664.7
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5
Day 1b: DENV-4
|
81.5 titres
Interval 67.8 to 98.1
|
172.9 titres
Interval 156.1 to 191.4
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5
Month 1b: DENV-1
|
179.8 titres
Interval 142.4 to 227.0
|
1493.8 titres
Interval 1383.2 to 1613.3
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5
Month 1b: DENV-2
|
174.8 titres
Interval 140.5 to 217.6
|
1611.5 titres
Interval 1492.1 to 1740.4
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5
Month 1b: DENV-3
|
159.9 titres
Interval 128.4 to 199.0
|
1546.6 titres
Interval 1450.0 to 1649.6
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5
Month 1b: DENV-4
|
87.3 titres
Interval 72.0 to 105.9
|
793.8 titres
Interval 742.5 to 848.7
|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes During Parts 4 And 5
Month 6b: DENV-1
|
191.5 titres
Interval 152.2 to 241.0
|
1000.9 titres
Interval 916.8 to 1092.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-booster Vaccination on Day 1b (Month 0b) versus post-booster vaccination on Day 30b (Month 1b) in Part 4Population: PPSI-B: all participants in FASI-B who had no major protocol violations. FASI-B: all participants from FAS-B who were included in booster immunogenicity subset \& for whom there is valid pre-booster measurement \& at least 1 valid post-booster measurement for immunogenicity assessments. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analyses for specified category.
The GMR is the geometric mean of the ratio of the two visits being compared.
Outcome measures
| Measure |
Placebo
n=396 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=1067 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each Dengue Serotype
DENV-1
|
0.9 unitless ratio
Interval 0.8 to 1.0
|
3.1 unitless ratio
Interval 2.8 to 3.4
|
|
Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each Dengue Serotype
DENV-2
|
0.9 unitless ratio
Interval 0.9 to 1.0
|
2.4 unitless ratio
Interval 2.3 to 2.6
|
|
Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each Dengue Serotype
DENV-3
|
1.1 unitless ratio
Interval 1.0 to 1.2
|
4.3 unitless ratio
Interval 3.9 to 4.7
|
|
Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each Dengue Serotype
DENV-4
|
0.9 unitless ratio
Interval 0.9 to 1.0
|
3.5 unitless ratio
Interval 3.2 to 3.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-booster Vaccination on Day 1b (Month 0b) versus post-booster vaccination on Day 180b (Month 6b) in Part 4Population: PPSI-B: all participants in FASI-B who had no major protocol violations. FASI-B: all participants from FAS-B who were included in booster immunogenicity subset \& for whom there is valid pre-booster measurement \& at least 1 valid post-booster measurement for immunogenicity assessments. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analyses for specified category.
The GMR is the geometric mean of the ratio of the two visits being compared.
Outcome measures
| Measure |
Placebo
n=408 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=1120 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
GMR of Neutralizing Antibodies for Each Dengue Serotype
DENV-1
|
1.0 unitless ratio
Interval 0.9 to 1.1
|
2.2 unitless ratio
Interval 2.0 to 2.4
|
|
GMR of Neutralizing Antibodies for Each Dengue Serotype
DENV-2
|
1.1 unitless ratio
Interval 1.0 to 1.3
|
1.8 unitless ratio
Interval 1.7 to 2.0
|
|
GMR of Neutralizing Antibodies for Each Dengue Serotype
DENV-3
|
1.0 unitless ratio
Interval 0.9 to 1.1
|
2.5 unitless ratio
Interval 2.3 to 2.7
|
|
GMR of Neutralizing Antibodies for Each Dengue Serotype
DENV-4
|
0.9 unitless ratio
Interval 0.8 to 1.0
|
2.1 unitless ratio
Interval 2.0 to 2.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-booster Vaccination on Day 1b (Month 0b) versus post-booster vaccination on Day 395b (Month 13b) in Part 4Population: PPSI-B: all participants in FASI-B who had no major protocol violations. FASI-B: all participants from FAS-B who were included in booster immunogenicity subset \& for whom there is valid pre-booster measurement \& at least 1 valid post-booster measurement for immunogenicity assessments. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analyses for specified category.
The geometric mean ratio is the geometric mean of the ratio of the two visits being compared.
Outcome measures
| Measure |
Placebo
n=408 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=1114 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
GMR of Neutralizing Antibodies for Each Dengue Serotype
DENV-1
|
1.3 unitless ratio
Interval 1.1 to 1.5
|
2.1 unitless ratio
Interval 1.9 to 2.3
|
|
GMR of Neutralizing Antibodies for Each Dengue Serotype
DENV-2
|
1.3 unitless ratio
Interval 1.1 to 1.5
|
1.6 unitless ratio
Interval 1.5 to 1.7
|
|
GMR of Neutralizing Antibodies for Each Dengue Serotype
DENV-3
|
1.3 unitless ratio
Interval 1.1 to 1.5
|
2.4 unitless ratio
Interval 2.2 to 2.6
|
|
GMR of Neutralizing Antibodies for Each Dengue Serotype
DENV-4
|
1.3 unitless ratio
Interval 1.1 to 1.4
|
2.0 unitless ratio
Interval 1.9 to 2.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-booster Vaccination on Day 1b (Month 0b) versus post-booster vaccination on Day 720b (Month 25b) in Part 5Population: PPSI-B: all participants in FASI-B who had no major protocol violations. FASI-B: all participants from FAS-B who were included in booster immunogenicity subset \& for whom there is valid pre-booster measurement \& at least 1 valid post-booster measurement for immunogenicity assessments. Overall number of participants analyzed: number of participants with data available for analyses. Number analyzed: number of participants with data available for analyses for specified category.
The geometric mean ratio is the geometric mean of the ratio of the two visits being compared.
Outcome measures
| Measure |
Placebo
n=398 Participants
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV 0.5 mL
n=1095 Participants
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
|---|---|---|
|
GMR of Neutralizing Antibodies for Each Dengue Serotype
DENV-3
|
1.4 unitless ratio
Interval 1.2 to 1.6
|
2.1 unitless ratio
Interval 1.9 to 2.3
|
|
GMR of Neutralizing Antibodies for Each Dengue Serotype
DENV-1
|
1.3 unitless ratio
Interval 1.2 to 1.5
|
2.0 unitless ratio
Interval 1.9 to 2.2
|
|
GMR of Neutralizing Antibodies for Each Dengue Serotype
DENV-2
|
1.3 unitless ratio
Interval 1.1 to 1.5
|
1.6 unitless ratio
Interval 1.5 to 1.7
|
|
GMR of Neutralizing Antibodies for Each Dengue Serotype
DENV-4
|
1.3 unitless ratio
Interval 1.1 to 1.5
|
1.9 unitless ratio
Interval 1.8 to 2.1
|
Adverse Events
Placebo
Serious events: 256 serious events
Other events: 527 other events
Deaths: 8 deaths
TDV (Part 1)
Serious events: 414 serious events
Other events: 1260 other events
Deaths: 22 deaths
Placebo (Part 2)
Serious events: 82 serious events
Other events: 0 other events
Deaths: 7 deaths
TDV (Part 2)
Serious events: 152 serious events
Other events: 0 other events
Deaths: 18 deaths
Placebo (Part 3)
Serious events: 397 serious events
Other events: 0 other events
Deaths: 7 deaths
TDV (Part 3)
Serious events: 666 serious events
Other events: 0 other events
Deaths: 17 deaths
Placebo (Part 4)
Serious events: 126 serious events
Other events: 149 other events
Deaths: 1 deaths
TDV (Part 4)
Serious events: 161 serious events
Other events: 409 other events
Deaths: 6 deaths
Placebo (Part 5)
Serious events: 73 serious events
Other events: 0 other events
Deaths: 0 deaths
TDV (Part 5)
Serious events: 109 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Placebo
n=6687 participants at risk
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV (Part 1)
n=13380 participants at risk
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study.
|
Placebo (Part 2)
n=6519 participants at risk
Participants went through extended follow-up period for six months up to Month 21 in Part 2 of the study.
|
TDV (Part 2)
n=13033 participants at risk
Participants went through extended follow-up period for six months up to Month 21 in Part 2 of the study.
|
Placebo (Part 3)
n=6487 participants at risk
Participants went through long-term follow-up (3 years) to evaluate the safety.
|
TDV (Part 3)
n=12961 participants at risk
Participants eligible for Booster Phase received placebo matching TDV, SC injection, based on the randomization on Day 1 (Month 0) in Part 4 of the study.
|
Placebo (Part 4)
n=2985 participants at risk
Participants eligible for Booster Phase received placebo matching TDV, SC injection, based on the randomization on Day 1 (Month 0)in Part 4 of the study.
|
TDV (Part 4)
n=5990 participants at risk
Participants eligible for Booster Phase received TDV, SC injection, based on the randomization on Day 1 (Month 0) in Part 4 of the study.
|
Placebo (Part 5)
n=2939 participants at risk
Participants went through extended follow-up period for 1 year up to Month 25b in Part 5 of the study.
|
TDV (Part 5)
n=5889 participants at risk
Participants went through extended follow-up period for 1 year up to Month 25b in Part 5 of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
4/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
3/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
4/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.07%
2/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Metabolism and nutrition disorders
Abnormal weight gain
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion complete
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion incomplete
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Surgical and medical procedures
Abortion induced
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Abortion infected
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.11%
7/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
6/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.10%
3/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous incomplete
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion threatened
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Abscess jaw
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Abscess limb
|
0.03%
2/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.04%
5/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
7/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Abscess neck
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Abscess of external ear
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Abscess soft tissue
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Acarodermatitis
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Accident at work
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Accidental exposure to product by child
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Acid peptic disease
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Acute disseminated encephalomyelitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Acute sinusitis
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Alveolar rhabdomyosarcoma
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Eye disorders
Amaurosis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Amniotic cavity infection
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Amoebiasis
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Amoebic dysentery
|
0.03%
2/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
6/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Blood and lymphatic system disorders
Anaemia of pregnancy
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Immune system disorders
Anaphylactic reaction
|
0.03%
2/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Anembryonic gestation
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.06%
4/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.06%
8/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
3/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.08%
10/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.07%
2/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Psychiatric disorders
Antisocial behaviour
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Appendiceal abscess
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Appendicitis
|
0.21%
14/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.22%
30/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.09%
6/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.11%
14/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.42%
27/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.46%
60/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.17%
5/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.12%
7/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.14%
4/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.20%
12/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.09%
6/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
7/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
3/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Aqueductal stenosis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Arboviral infection
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Ascariasis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.03%
2/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
7/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
7/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.04%
5/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
3/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.04%
3/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Bacterial sepsis
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Bartholin's abscess
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Psychiatric disorders
Behaviour disorder
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Vascular disorders
Behcet's syndrome
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign hydatidiform mole
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Psychiatric disorders
Bipolar I disorder
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Blindness traumatic
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Brain hypoxia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Breast cellulitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Bronchitis
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
4/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Bullous impetigo
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Burkholderia pseudomallei infection
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Burn infection
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.37%
24/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.53%
69/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
1.3%
39/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
1.1%
65/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
3/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
7/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Eye disorders
Cataract
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Cellulitis
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.07%
10/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.11%
7/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.12%
15/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.07%
2/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
3/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Cellulitis orbital
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Cephalo-pelvic disproportion
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Congenital, familial and genetic disorders
Cerebral arteriovenous malformation haemorrhagic
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Cerebral venous thrombosis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Congenital, familial and genetic disorders
Cerebrovascular arteriovenous malformation
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Chemical burn of oral cavity
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
General disorders
Chest pain
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Chikungunya virus infection
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Hepatobiliary disorders
Cholangitis sclerosing
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Cholera
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
4/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Complicated appendicitis
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.04%
6/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.11%
7/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.09%
12/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.13%
4/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.07%
2/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Constipation
|
0.03%
2/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
3/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.04%
5/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Eye disorders
Corneal opacity
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Craniofacial fracture
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Congenital, familial and genetic disorders
Cryptorchism
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Endocrine disorders
Cushing's syndrome
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cutaneous T-cell lymphoma
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Cystitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Blood and lymphatic system disorders
Deficiency anaemia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
3/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Dengue fever
|
0.78%
52/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.10%
13/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.15%
10/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.07%
9/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
1.3%
83/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.43%
56/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
1.1%
32/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.12%
7/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.58%
17/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.15%
9/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Dengue haemorrhagic fever
|
0.28%
19/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
4/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.09%
6/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.18%
12/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.07%
9/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.13%
4/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.10%
3/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
7/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.07%
2/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Dermatitis infected
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Desmoplastic small round cell tumour
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Product Issues
Device extrusion
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Product Issues
Device malfunction
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Device related infection
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Diplegia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Psychiatric disorders
Disruptive mood dysregulation disorder
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Disseminated tuberculosis
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
General disorders
Drowning
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Immune system disorders
Drug hypersensitivity
|
0.03%
2/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Dysentery
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Eclampsia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Electric injury
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Electric shock
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Electrical burn
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Vascular disorders
Embolism
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ependymoma malignant
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Epidural haemorrhage
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Epiphyseal injury
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Musculoskeletal and connective tissue disorders
Epiphysiolysis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Erysipelas
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Skin and subcutaneous tissue disorders
Erythema annulare
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Erythema infectiosum
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Musculoskeletal and connective tissue disorders
Exostosis of jaw
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Exposure to communicable disease
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Extradural abscess
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Musculoskeletal and connective tissue disorders
Extremity contracture
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Eye infection gonococcal
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Eyelid injury
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
4/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.10%
3/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
False labour
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Investigations
False positive investigation result
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Congenital, familial and genetic disorders
Familial periodic paralysis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Febrile convulsion
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
4/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Focal peritonitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Immune system disorders
Food allergy
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Food poisoning
|
0.04%
3/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
3/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.07%
2/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.03%
2/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.06%
8/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.07%
9/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.13%
4/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
3/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.07%
2/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Foreign body in gastrointestinal tract
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Gangrene
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Gastritis
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.04%
6/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
3/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
3/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
6/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Gastritis viral
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Gastroenteritis
|
0.12%
8/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.22%
29/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
7/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.17%
11/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.14%
18/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.07%
2/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.07%
4/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Gastroenteritis shigella
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Gastrointestinal bacterial infection
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Giardiasis
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Renal and urinary disorders
Glomerulonephritis acute
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Renal and urinary disorders
Glomerulonephritis chronic
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Renal and urinary disorders
Glomerulonephritis proliferative
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Renal and urinary disorders
Glomerulonephritis rapidly progressive
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Endocrine disorders
Goitre
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Musculoskeletal and connective tissue disorders
Greater trochanteric pain syndrome
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Groin abscess
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
3/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
3/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.04%
5/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
General disorders
Hanging
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.04%
3/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
4/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Headache
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Skin and subcutaneous tissue disorders
Henoch-Schonlein purpura
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Hepatic rupture
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Hepatitis A
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Hepatitis viral
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Herpes simplex encephalitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
High risk pregnancy
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Social circumstances
High risk sexual behaviour
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.04%
3/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.07%
10/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
7/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Hyperemesis gravidarum
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Immune system disorders
Hypersensitivity
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Renal and urinary disorders
Hypertensive nephropathy
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Endocrine disorders
Hyperthyroidism
|
0.03%
2/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Hypoaesthesia
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Idiopathic generalised epilepsy
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Renal and urinary disorders
IgA nephropathy
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Ilium fracture
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Impetigo
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Infected bite
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Infective exacerbation of asthma
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Infective myositis
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Inflammatory myofibroblastic tumour
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Influenza
|
0.10%
7/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.10%
14/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.08%
5/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
6/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.14%
9/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.09%
12/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
3/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
General disorders
Influenza like illness
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Psychiatric disorders
Intentional self-injury
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Joint abscess
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.07%
2/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Musculoskeletal and connective tissue disorders
Juvenile idiopathic arthritis
|
0.03%
2/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Vascular disorders
Kawasaki's disease
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Musculoskeletal and connective tissue disorders
Knee deformity
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Labour complication
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Leptospirosis
|
0.03%
2/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
4/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Liver contusion
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Localised infection
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
4/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.04%
3/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.07%
10/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
3/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Ludwig angina
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Renal and urinary disorders
Lupus nephritis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Respiratory, thoracic and mediastinal disorders
Lupus pleurisy
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Lymph gland infection
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Lymph node tuberculosis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Lymphadenitis bacterial
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Lymphoid hyperplasia of intestine
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Malaria
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Psychiatric disorders
Mania
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Measles
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Medulloblastoma
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Meningitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Meningitis aseptic
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Meningitis tuberculous
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Mesenteric cyst
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Blood and lymphatic system disorders
Mesenteric lymphadenitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.04%
5/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
4/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.07%
2/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Hepatobiliary disorders
Metabolic dysfunction-associated steatohepatitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Metabolism and nutrition disorders
Metabolic syndrome
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Migraine
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Psychiatric disorders
Mixed anxiety and depressive disorder
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
4/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Muscle abscess
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Congenital, familial and genetic disorders
Muscular dystrophy
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Eye disorders
Myopia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Nasopharyngitis
|
0.04%
3/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Renal and urinary disorders
Nephritic syndrome
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Obstetric infection
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Open globe injury
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Psychiatric disorders
Oppositional defiant disorder
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Oral herpes
|
0.03%
2/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Eye disorders
Orbital myositis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Orchitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
General disorders
Organ failure
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Osteochondroma
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Osteomyelitis chronic
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Otitis media
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Otitis media acute
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell endodermal sinus tumour stage IV
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Reproductive system and breast disorders
Ovulation pain
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Pancreatic injury
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Pancreatic pseudocyst
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Paranasal sinus abscess
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Parasite allergy
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Parasitic gastroenteritis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Parotitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Penetrating abdominal trauma
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Reproductive system and breast disorders
Penile adhesion
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Perineal injury
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Periorbital abscess
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
3/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Pharyngitis bacterial
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.03%
2/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Social circumstances
Physical assault
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Pilonidal disease
|
0.03%
2/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Placental insufficiency
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Pneumonia
|
0.12%
8/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.07%
10/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.11%
7/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
6/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.12%
8/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.15%
20/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
3/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Pneumonia bacterial
|
0.03%
2/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Vascular disorders
Polyarteritis nodosa
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Polyhydramnios
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Hepatobiliary disorders
Portal hypertension
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Renal and urinary disorders
Post infection glomerulonephritis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Renal and urinary disorders
Post streptococcal glomerulonephritis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.04%
5/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Post-traumatic headache
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Postoperative adhesion
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Postoperative wound infection
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
4/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum haemorrhage
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Postpartum sepsis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.06%
4/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.07%
9/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Premature delivery
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
3/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.06%
8/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.07%
2/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
3/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Premature rupture of membranes
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Premature separation of placenta
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Preterm premature rupture of membranes
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Psychiatric disorders
Psychiatric symptom
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Psychogenic seizure
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Puerperal infection
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
4/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Pustule
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Renal and urinary disorders
Pyelocaliectasis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Pyelonephritis
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.06%
4/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.07%
2/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Pyoderma
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
General disorders
Pyrexia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.04%
5/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Quadriparesis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.10%
7/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.09%
12/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
3/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Eye disorders
Refraction disorder
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Musculoskeletal and connective tissue disorders
Rheumatic fever
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Cardiac disorders
Rheumatic heart disease
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Rickettsiosis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.06%
8/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.07%
9/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.10%
3/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
3/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.10%
3/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.10%
6/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Ruptured ectopic pregnancy
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
SARS-CoV-2 sepsis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Salpingitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Scarlet fever
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Schwannoma
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Seizure
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Psychiatric disorders
Self-destructive behaviour
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.06%
4/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Septic phlebitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Septic shock
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
General disorders
Serositis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Serotonin syndrome
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Social circumstances
Sexual abuse
|
0.04%
3/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
4/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Vascular disorders
Shock
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Shunt malfunction
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Simple partial seizures
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus polyp
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.03%
2/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Snake bite
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Spinal cord injury thoracic
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Sports injury
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Staphylococcal abscess
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Status migrainosus
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Subcutaneous abscess
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
4/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Vascular disorders
Subgaleal haematoma
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Social circumstances
Substance use
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Psychiatric disorders
Substance use disorder
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Psychiatric disorders
Suicidal behaviour
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Psychiatric disorders
Suicide attempt
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.08%
5/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.04%
5/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.07%
2/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Superinfection
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Syncope
|
0.03%
2/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Syphilis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Systemic viral infection
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Testicular injury
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Reproductive system and breast disorders
Testicular torsion
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Congenital, familial and genetic disorders
Thalassaemia alpha
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Threatened labour
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Blood and lymphatic system disorders
Thrombocytopenic purpura
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.03%
2/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.04%
5/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.07%
4/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Tinea capitis
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Tonsillitis
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
3/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Tonsillitis bacterial
|
0.03%
2/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
4/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Tooth abscess
|
0.03%
2/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.04%
5/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.07%
2/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Traumatic delivery
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Traumatic lung injury
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Immune system disorders
Type I hypersensitivity
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Typhoid fever
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ulcerated haemangioma
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Umbilical cord prolapse
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Pregnancy, puerperium and perinatal conditions
Unstable foetal lie
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
2/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.07%
5/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.06%
4/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.07%
9/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Renal and urinary disorders
Urethral caruncle
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Urethritis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Renal and urinary disorders
Urinary bladder rupture
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Urinary tract infection
|
0.07%
5/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.07%
9/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
2/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
4/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.23%
15/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.15%
20/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
3/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.07%
2/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
3/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
4/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
2/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Vaginal infection
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Varicella
|
0.03%
2/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Venom poisoning
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Social circumstances
Victim of crime
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Social circumstances
Victim of sexual abuse
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Viral infection
|
0.28%
19/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.17%
23/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.06%
4/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.26%
17/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.12%
16/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.10%
3/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.17%
5/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.05%
3/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Viral myocarditis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Viral rash
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
4/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Reproductive system and breast disorders
Vulval haematoma
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Vulvovaginal injury
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.01%
1/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Infections and infestations
Wound infection
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.01%
1/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
3/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.03%
1/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.02%
1/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
Other adverse events
| Measure |
Placebo
n=6687 participants at risk
Participants received placebo-matching TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study.
|
TDV (Part 1)
n=13380 participants at risk
Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study.
|
Placebo (Part 2)
n=6519 participants at risk
Participants went through extended follow-up period for six months up to Month 21 in Part 2 of the study.
|
TDV (Part 2)
n=13033 participants at risk
Participants went through extended follow-up period for six months up to Month 21 in Part 2 of the study.
|
Placebo (Part 3)
n=6487 participants at risk
Participants went through long-term follow-up (3 years) to evaluate the safety.
|
TDV (Part 3)
n=12961 participants at risk
Participants eligible for Booster Phase received placebo matching TDV, SC injection, based on the randomization on Day 1 (Month 0) in Part 4 of the study.
|
Placebo (Part 4)
n=2985 participants at risk
Participants eligible for Booster Phase received placebo matching TDV, SC injection, based on the randomization on Day 1 (Month 0)in Part 4 of the study.
|
TDV (Part 4)
n=5990 participants at risk
Participants eligible for Booster Phase received TDV, SC injection, based on the randomization on Day 1 (Month 0) in Part 4 of the study.
|
Placebo (Part 5)
n=2939 participants at risk
Participants went through extended follow-up period for 1 year up to Month 25b in Part 5 of the study.
|
TDV (Part 5)
n=5889 participants at risk
Participants went through extended follow-up period for 1 year up to Month 25b in Part 5 of the study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
5.0%
337/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
5.5%
736/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
2.7%
82/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
3.4%
206/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
|
General disorders
Pain
|
5.4%
363/6687 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
7.6%
1011/13380 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6519 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/13033 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/6487 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/12961 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
3.8%
113/2985 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
5.7%
340/5990 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/2939 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
|
0.00%
0/5889 • Part 1+ Part 2 combined: Deaths and SAEs from Day1 until end of Part 2(approx.21 months); Other AEs up to 28 days post first/second vaccination- i.e. only Part1; Part3: Deaths and SAEs during Part3(approx.3 years); no Other AEs collected during Part 3; Part 4+ Part 5 combined: Deaths and SAEs from booster vaccination (Day 1b) until end of Part 5 [approx. 25 months]; Other AEs up to 28 days post booster vaccination- i.e. only Part 4).
As pre-specified in protocol, AEs are reported separately for Placebo and TDV arms of each Part. For Part 1-3: Safety Set. For Part 4-5: Safety Set-Booster.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
- Publication restrictions are in place
Restriction type: OTHER