Trial Outcomes & Findings for A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone or Co-administered With an Adjuvanted Vaccine Against Influenza in Adults Aged 65 Years and Above (NCT NCT05568797)
NCT ID: NCT05568797
Last Updated: 2024-09-24
Results Overview
HI antibodies assessed were antibodies against the Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata flu strains.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1045 participants
Primary outcome timeframe
At 1 month after the FLU vaccine dose (Day 31 for both groups)
Results posted on
2024-09-24
Participant Flow
All 1045 enrolled participants were randomized to Co-Ad and Control Groups and received at least 1 dose of study intervention and were included in the exposed set.
This study assessed the immunogenicity, safety and reactogenicity of the RSVPre3 OA vaccine when co-administered with an adjuvanted quadrivalent influenza (FLU-aQIV \[FLU\]) vaccine, in adults aged 65 years old or above.
Participant milestones
| Measure |
Co-Ad Group
Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study.
|
|---|---|---|
|
Overall Study
STARTED
|
523
|
522
|
|
Overall Study
COMPLETED
|
518
|
499
|
|
Overall Study
NOT COMPLETED
|
5
|
23
|
Reasons for withdrawal
| Measure |
Co-Ad Group
Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
8
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
10
|
|
Overall Study
Other
|
2
|
2
|
Baseline Characteristics
A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone or Co-administered With an Adjuvanted Vaccine Against Influenza in Adults Aged 65 Years and Above
Baseline characteristics by cohort
| Measure |
Co-Ad Group
n=523 Participants
Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=522 Participants
Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study.
|
Total
n=1045 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.1 YEARS
STANDARD_DEVIATION 5.4 • n=5 Participants
|
72.2 YEARS
STANDARD_DEVIATION 5.2 • n=7 Participants
|
72.2 YEARS
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
255 Participants
n=5 Participants
|
275 Participants
n=7 Participants
|
530 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
268 Participants
n=5 Participants
|
247 Participants
n=7 Participants
|
515 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
522 Participants
n=5 Participants
|
516 Participants
n=7 Participants
|
1038 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other - Unspecified
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 1 month after the FLU vaccine dose (Day 31 for both groups)Population: Analysis was performed on Per Protocol Set for FLU analysis which included eligible participants who: received at least one control group intervention or all Co-Ad group interventions, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, with immunogenicity data available for the specified analysis at the specified time point post-FLU vaccine dose, who lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.
HI antibodies assessed were antibodies against the Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata flu strains.
Outcome measures
| Measure |
Co-Ad Group
n=429 Participants
Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=400 Participants
Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study.
|
|---|---|---|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 FLU Vaccine Strains Expressed as Group Geometric Mean Titers (GMTs) at 1 Month After FLU Vaccine Dose
Flu B/Austria/1359417/2021 Victoria
|
613.9 Titers
Interval 575.1 to 655.2
|
597.5 Titers
Interval 558.7 to 639.1
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 FLU Vaccine Strains Expressed as Group Geometric Mean Titers (GMTs) at 1 Month After FLU Vaccine Dose
Flu A/Darwin/6/2021 H3N2
|
43.8 Titers
Interval 38.9 to 49.4
|
57.7 Titers
Interval 51.0 to 65.3
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 FLU Vaccine Strains Expressed as Group Geometric Mean Titers (GMTs) at 1 Month After FLU Vaccine Dose
Flu A/Victoria/2570/2019 H1N1
|
143.0 Titers
Interval 128.6 to 159.0
|
148.5 Titers
Interval 133.2 to 165.6
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against 4 FLU Vaccine Strains Expressed as Group Geometric Mean Titers (GMTs) at 1 Month After FLU Vaccine Dose
Flu B/Phuket/3073/2013 Yamagata
|
406.2 Titers
Interval 380.0 to 434.2
|
421.0 Titers
Interval 393.0 to 451.0
|
PRIMARY outcome
Timeframe: At 1 month after the RSVPreF3 OA dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group)Population: Analysis was performed on Per Protocol Set for RSV OA analysis which included eligible participants who: received at least one control group intervention or all Co-Ad group interventions, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, with immunogenicity data available for the specified analysis at the specified time point post-RSVPreF3 OA vaccine dose, who lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.
RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dilution 60 (ED60).
Outcome measures
| Measure |
Co-Ad Group
n=471 Participants
Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=373 Participants
Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study.
|
|---|---|---|
|
RSV-A Neutralizing Antibody Titers Expressed as GMTs
|
6673.4 Titers
Interval 6057.2 to 7352.4
|
6591.8 Titers
Interval 5917.8 to 7342.6
|
PRIMARY outcome
Timeframe: At 1 month after the RSVPreF3 OA dose (Day 31 for the CoAd Group and Day 61 for the Control Group)Population: Analysis was performed on Per Protocol Set for RSV OA analysis which included eligible participants who: received at least one control group intervention or all Co-Ad group interventions, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, with immunogenicity data available for the specified analysis at the specified time point post-RSVPreF3 OA vaccine dose, who lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.
RSV B neutralizing antibodies are given as GMTs and expressed as Estimated Dilution 60 (ED60).
Outcome measures
| Measure |
Co-Ad Group
n=469 Participants
Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=373 Participants
Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study.
|
|---|---|---|
|
RSV-B Neutralizing Antibody Titers Expressed as GMTs
|
7880.1 Titers
Interval 7195.4 to 8629.8
|
9134.1 Titers
Interval 8255.9 to 10105.7
|
SECONDARY outcome
Timeframe: At 1 month after the FLU vaccine dose (Day 31 for both groups)Population: Analysis was performed on Per Protocol Set for FLU analysis which included eligible participants who: received at least one control group intervention or all Co-Ad group interventions, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, with immunogenicity data available for the specified analysis at the specified time point post-FLU vaccine dose, who lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.
SCR for HI antibody is defined as the percentage of participants who have either a HI predose titer less than (\<) 1:10 and a post-dose titer greater than or equal to (\>=) 1:40, or a pre-dose titer \>= 1:10 and at least a 4-fold increase in post-dose titer. The assessed Flu strains were: Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata.
Outcome measures
| Measure |
Co-Ad Group
n=429 Participants
Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=400 Participants
Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study.
|
|---|---|---|
|
HI Seroconversion Rate (SCR) for 4 FLU Vaccine Strains
Flu A/Darwin/6/2021 H3N2
|
51.7 Percentage of participants
Interval 46.9 to 56.6
|
62.0 Percentage of participants
Interval 57.0 to 66.8
|
|
HI Seroconversion Rate (SCR) for 4 FLU Vaccine Strains
Flu A/Victoria/2570/2019 H1N1
|
44.0 Percentage of participants
Interval 39.2 to 48.9
|
45.7 Percentage of participants
Interval 40.7 to 50.8
|
|
HI Seroconversion Rate (SCR) for 4 FLU Vaccine Strains
Flu B/Austria/1359417/2021 Victoria
|
17.2 Percentage of participants
Interval 13.8 to 21.2
|
17.5 Percentage of participants
Interval 13.9 to 21.6
|
|
HI Seroconversion Rate (SCR) for 4 FLU Vaccine Strains
Flu B/Phuket/3073/2013 Yamagata
|
18.5 Percentage of participants
Interval 14.9 to 22.5
|
19.3 Percentage of participants
Interval 15.5 to 23.5
|
SECONDARY outcome
Timeframe: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) compared to pre-vaccination (Day 1 for Co-Ad group and Day 31 for Control group)Population: Analysis was performed on Per Protocol Set for RSV OA analysis which included eligible participants who: received at least one control group intervention or all Co-Ad group interventions, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, with immunogenicity data available for the specified analysis at the specified time point post-RSVPreF3 OA vaccine dose, who lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.
MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer.
Outcome measures
| Measure |
Co-Ad Group
n=471 Participants
Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=373 Participants
Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study.
|
|---|---|---|
|
RSV-A Neutralization Antibody Titers Expressed as Mean Geometric Increase (MGI)
|
8.50 Ratio
Interval 7.79 to 9.27
|
7.58 Ratio
Interval 6.82 to 8.42
|
SECONDARY outcome
Timeframe: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) compared to pre-vaccination (Day 1 for Co-Ad group and Day 31 for Control group)Population: Analysis was performed on Per Protocol Set for RSV OA analysis which included eligible participants who: received at least one control group intervention or all Co-Ad group interventions, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, with immunogenicity data available for the specified analysis at the specified time point post-RSVPreF3 OA vaccine dose, who lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.
MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer.
Outcome measures
| Measure |
Co-Ad Group
n=469 Participants
Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=373 Participants
Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study.
|
|---|---|---|
|
RSV-B Neutralization Antibody Titers Expressed as MGI
|
7.11 Ratio
Interval 6.55 to 7.72
|
7.46 Ratio
Interval 6.74 to 8.25
|
SECONDARY outcome
Timeframe: At Day 1 (Baseline) and Day 31Population: Analysis was performed on Per Protocol Set for FLU analysis which included eligible participants who: received at least one control group intervention or all Co-Ad group interventions, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, with immunogenicity data available for the specified analysis at the specified time point post-FLU vaccine dose, who lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.
HI antibodies assessed were antibodies against the Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata flu strains. HI antibodies were expressed as GMT, in titers.
Outcome measures
| Measure |
Co-Ad Group
n=469 Participants
Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=449 Participants
Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study.
|
|---|---|---|
|
Titers for HI Antibodies Against 4 FLU Vaccine Strains
Flu A/Darwin/6/2021 H3N2, Day 1
|
9.1 Titers
Interval 8.4 to 9.8
|
8.7 Titers
Interval 8.1 to 9.4
|
|
Titers for HI Antibodies Against 4 FLU Vaccine Strains
Flu A/Darwin/6/2021 H3N2 , Day 31
|
45.3 Titers
Interval 40.6 to 50.5
|
58.3 Titers
Interval 51.6 to 65.8
|
|
Titers for HI Antibodies Against 4 FLU Vaccine Strains
Flu A/Victoria/2570/2019 H1N1, Day 1
|
40.0 Titers
Interval 35.4 to 45.1
|
43.2 Titers
Interval 38.4 to 48.5
|
|
Titers for HI Antibodies Against 4 FLU Vaccine Strains
Flu A/Victoria/2570/2019 H1N1, Day 31
|
151.0 Titers
Interval 136.4 to 167.2
|
163.8 Titers
Interval 147.5 to 181.9
|
|
Titers for HI Antibodies Against 4 FLU Vaccine Strains
Flu B/Austria/1359417/2021 Victoria, Day 1
|
323.6 Titers
Interval 300.4 to 348.5
|
327.2 Titers
Interval 303.6 to 352.7
|
|
Titers for HI Antibodies Against 4 FLU Vaccine Strains
Flu B/Austria/1359417/2021 Victoria, Day 31
|
614.9 Titers
Interval 575.5 to 657.0
|
608.1 Titers
Interval 566.8 to 652.5
|
|
Titers for HI Antibodies Against 4 FLU Vaccine Strains
Flu B/Phuket/3073/2013 Yamagata, Day 1
|
213.1 Titers
Interval 198.5 to 228.7
|
193.2 Titers
Interval 179.9 to 207.5
|
|
Titers for HI Antibodies Against 4 FLU Vaccine Strains
Flu B/Phuket/3073/2013 Yamagata, Day 31
|
423.0 Titers
Interval 394.6 to 453.5
|
417.5 Titers
Interval 387.9 to 449.4
|
SECONDARY outcome
Timeframe: At Day 1 (Baseline) and Day 31Population: Analysis was performed on Per Protocol Set for FLU analysis which included eligible participants who: received at least one control group intervention or all Co-Ad group interventions, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, with immunogenicity data available for the specified analysis at the specified time point post-FLU vaccine dose, who lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.
SPR for HI antibody was defined as the percentage of participants with a serum HI titer \>= 1:40. The assessed Flu strains were: Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata.
Outcome measures
| Measure |
Co-Ad Group
n=469 Participants
Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=449 Participants
Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study.
|
|---|---|---|
|
HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains
Flu A/Darwin/6/2021 H3N2, Day 1
|
10.4 Percentage of participants
Interval 7.8 to 13.6
|
10.7 Percentage of participants
Interval 8.0 to 13.9
|
|
HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains
Flu A/Darwin/6/2021 H3N2, Day 31
|
63.6 Percentage of participants
Interval 58.9 to 68.1
|
71.0 Percentage of participants
Interval 66.3 to 75.4
|
|
HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains
Flu A/Victoria/2570/2019 H1N1, Day 1
|
60.0 Percentage of participants
Interval 55.4 to 64.5
|
64.3 Percentage of participants
Interval 59.7 to 68.8
|
|
HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains
Flu A/Victoria/2570/2019 H1N1, Day 31
|
92.0 Percentage of participants
Interval 89.1 to 94.4
|
95.2 Percentage of participants
Interval 92.7 to 97.1
|
|
HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains
Flu B/Austria/1359417/2021 Victoria, Day 1
|
99.6 Percentage of participants
Interval 98.5 to 99.9
|
100 Percentage of participants
Interval 99.2 to 100.0
|
|
HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains
Flu B/Austria/1359417/2021 Victoria, Day 31
|
100 Percentage of participants
Interval 99.2 to 100.0
|
100 Percentage of participants
Interval 99.1 to 100.0
|
|
HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains
Flu B/Phuket/3073/2013 Yamagata, Day 1
|
99.8 Percentage of participants
Interval 98.8 to 100.0
|
98.9 Percentage of participants
Interval 97.4 to 99.6
|
|
HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains
Flu B/Phuket/3073/2013 Yamagata, Day 31
|
100 Percentage of participants
Interval 99.2 to 100.0
|
100 Percentage of participants
Interval 99.1 to 100.0
|
SECONDARY outcome
Timeframe: At 1 month after the FLU dose (Day 31 for both groups) compared to pre-vaccination (Day 1 for both groups)Population: Analysis was performed on Per Protocol Set for FLU analysis which included eligible participants who: received at least one control group intervention or all Co-Ad group interventions, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, with immunogenicity data available for the specified analysis at the specified time point post-FLU vaccine dose, who lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.
MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer. The assessed Flu strains were: Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata.
Outcome measures
| Measure |
Co-Ad Group
n=429 Participants
Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=400 Participants
Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study.
|
|---|---|---|
|
HI Antibody Titers for 4 FLU Vaccine Strains Expressed as MGI
Flu A/Darwin/6/2021 H3N2 HI
|
5.10 Ratio
Interval 4.6 to 5.66
|
6.87 Ratio
Interval 6.12 to 7.71
|
|
HI Antibody Titers for 4 FLU Vaccine Strains Expressed as MGI
Flu A/Victoria/2570/2019 H1N1 HI
|
3.85 Ratio
Interval 3.4 to 4.35
|
3.79 Ratio
Interval 3.34 to 4.31
|
|
HI Antibody Titers for 4 FLU Vaccine Strains Expressed as MGI
Flu B/Phuket/3073/2013 Yamagata HI
|
1.94 Ratio
Interval 1.82 to 2.07
|
2.11 Ratio
Interval 1.97 to 2.27
|
|
HI Antibody Titers for 4 FLU Vaccine Strains Expressed as MGI
Flu B/Austria/1359417/2021 Victoria HI
|
1.89 Ratio
Interval 1.77 to 2.03
|
1.84 Ratio
Interval 1.71 to 1.98
|
SECONDARY outcome
Timeframe: Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 for CoAd Group and at Day 1 and Day 31 for Control group)Population: Analysis was performed on Exposed set which included participants who received a study intervention and with the electronic diary completed post-each vaccination and for whom solicited administration event data was available for specific visit. The Control group received FLU vaccination at Day 1 and RSVPreF3 OA vaccination at Day 31; Co-Ad group received co-administered vaccine (RSVPreF3 OA + FLU) on Day 1. Analysis per group is based on the study intervention administered on specific visit.
The solicited administration site events after vaccination include erythema, pain and swelling.
Outcome measures
| Measure |
Co-Ad Group
n=516 Participants
Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=513 Participants
Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study.
|
|---|---|---|
|
Percentage of Participants Reporting Each Solicited Administration Site Event After Each Vaccine Dose Administration
Erythema, FLU dose given at Day 1
|
6.6 Percentage of participants
Interval 4.6 to 9.1
|
5.3 Percentage of participants
Interval 3.5 to 7.6
|
|
Percentage of Participants Reporting Each Solicited Administration Site Event After Each Vaccine Dose Administration
Erythema, RSV dose given at Day 1
|
14.1 Percentage of participants
Interval 11.3 to 17.5
|
—
|
|
Percentage of Participants Reporting Each Solicited Administration Site Event After Each Vaccine Dose Administration
Erythema, RSV dose given at Day 31
|
—
|
12.4 Percentage of participants
Interval 9.5 to 15.8
|
|
Percentage of Participants Reporting Each Solicited Administration Site Event After Each Vaccine Dose Administration
Pain, FLU dose given at Day 1
|
51.7 Percentage of participants
Interval 47.3 to 56.1
|
44.8 Percentage of participants
Interval 40.5 to 49.3
|
|
Percentage of Participants Reporting Each Solicited Administration Site Event After Each Vaccine Dose Administration
Pain, RSV dose given at Day 1
|
66.1 Percentage of participants
Interval 61.8 to 70.2
|
—
|
|
Percentage of Participants Reporting Each Solicited Administration Site Event After Each Vaccine Dose Administration
Pain, RSV dose given at Day 31
|
—
|
58.8 Percentage of participants
Interval 54.1 to 63.3
|
|
Percentage of Participants Reporting Each Solicited Administration Site Event After Each Vaccine Dose Administration
Swelling, FLU dose given at Day 1
|
5.2 Percentage of participants
Interval 3.5 to 7.5
|
6.0 Percentage of participants
Interval 4.1 to 8.5
|
|
Percentage of Participants Reporting Each Solicited Administration Site Event After Each Vaccine Dose Administration
Swelling, RSV dose given at Day 1
|
10.5 Percentage of participants
Interval 8.0 to 13.4
|
—
|
|
Percentage of Participants Reporting Each Solicited Administration Site Event After Each Vaccine Dose Administration
Swelling, RSV dose given at Day 31
|
—
|
8.4 Percentage of participants
Interval 6.0 to 11.4
|
SECONDARY outcome
Timeframe: Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 and Day 31 for C-oAd Group and at Day 1 and Day 31 for Control group)Population: Analysis was performed on Exposed set which included participants who received a study intervention and with the electronic diary completed post-each vaccination and for whom solicited administration event data was available for specific visit. The Control group received FLU vaccination at Day 1 and RSVPreF3 OA vaccination at Day 31; Co-Ad group received co-administered vaccine (RSVPreF3 OA + FLU) on Day 1. Analysis per group is based on the study intervention administered on specific visit.
The solicited systemic events after vaccination include fever, headache, fatigue, myalgia and arthralgia.
Outcome measures
| Measure |
Co-Ad Group
n=516 Participants
Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=513 Participants
Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study.
|
|---|---|---|
|
Percentage of Participants Reporting Each Solicited Systemic Event After Each Dose Administration
Arthralgia, Dosing at Day 1
|
25.8 Percentage of participants
Interval 22.1 to 29.8
|
15.6 Percentage of participants
Interval 12.6 to 19.0
|
|
Percentage of Participants Reporting Each Solicited Systemic Event After Each Dose Administration
Arthralgia, Dosing at Day 31
|
—
|
17.1 Percentage of participants
Interval 13.7 to 20.9
|
|
Percentage of Participants Reporting Each Solicited Systemic Event After Each Dose Administration
Fatigue, Dosing at Day 1
|
45.7 Percentage of participants
Interval 41.4 to 50.1
|
28.5 Percentage of participants
Interval 24.6 to 32.6
|
|
Percentage of Participants Reporting Each Solicited Systemic Event After Each Dose Administration
Fatigue, Dosing at Day 31
|
—
|
30.4 Percentage of participants
Interval 26.2 to 34.9
|
|
Percentage of Participants Reporting Each Solicited Systemic Event After Each Dose Administration
Fever, Dosing at Day 1
|
2.1 Percentage of participants
Interval 1.1 to 3.8
|
0.6 Percentage of participants
Interval 0.1 to 1.7
|
|
Percentage of Participants Reporting Each Solicited Systemic Event After Each Dose Administration
Fever, Dosing at Day 31
|
—
|
1.1 Percentage of participants
Interval 0.4 to 2.6
|
|
Percentage of Participants Reporting Each Solicited Systemic Event After Each Dose Administration
Headache, Dosing at Day 1
|
32.2 Percentage of participants
Interval 28.2 to 36.4
|
19.3 Percentage of participants
Interval 16.0 to 23.0
|
|
Percentage of Participants Reporting Each Solicited Systemic Event After Each Dose Administration
Headache, Dosing at Day 31
|
—
|
23.9 Percentage of participants
Interval 20.1 to 28.2
|
|
Percentage of Participants Reporting Each Solicited Systemic Event After Each Dose Administration
Myalgia, Dosing at Day 1
|
39.0 Percentage of participants
Interval 34.7 to 43.3
|
23.0 Percentage of participants
Interval 19.4 to 26.9
|
|
Percentage of Participants Reporting Each Solicited Systemic Event After Each Dose Administration
Myalgia, Dosing at Day 31
|
—
|
31.9 Percentage of participants
Interval 27.6 to 36.5
|
SECONDARY outcome
Timeframe: Within 30 days (the day of vaccination and 29 subsequent days) after each vaccine administrationPopulation: Analysis was performed on Exposed set which included participants who received at least a study intervention and had data for the assessed timepoint and analysis.
An unsolicited AEs is an AE that is not included in a list of solicited events using a Participant Electronic Diary. Unsolicited events must be spontaneously communicated by a participant who signs the informed consent. Unsolicited AEs include both serious, non-serious AEs and potential immune-mediated diseases (pIMDs).
Outcome measures
| Measure |
Co-Ad Group
n=523 Participants
Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=522 Participants
Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study.
|
|---|---|---|
|
Percentage of Participants Reporting Unsolicited Adverse Events (AEs)
|
13.6 Percentage of participants
Interval 10.8 to 16.8
|
24.5 Percentage of participants
Interval 20.9 to 28.4
|
SECONDARY outcome
Timeframe: From Day 1 until 6 months after last vaccination (Month 6 for the Co-Ad Group, Month 7 for the Control group)Population: Analysis was performed on Exposed set which included participants who received at least a study intervention and had data for the assessed timepoint and analysis.
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant.
Outcome measures
| Measure |
Co-Ad Group
n=523 Participants
Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=522 Participants
Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study.
|
|---|---|---|
|
Percentage of Participants Reporting at Least One Serious Adverse Event (SAEs)
|
4.0 Percentage of participants
Interval 2.5 to 6.1
|
6.9 Percentage of participants
Interval 4.9 to 9.4
|
SECONDARY outcome
Timeframe: From Day 1 until 6 months after last vaccination (Month 6 for the Co-Ad Group, Month 7 for the Control group)Population: Analysis was performed on Exposed set which included participants who received at least a study intervention and had data for the assessed timepoint and analysis.
pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. The investigator must exercise his/her medical/scientific judgment to determine whether other diseases have an autoimmune origin (i.e., pathophysiology involving systemic or organ-specific pathogenic autoantibodies) and should also be recorded as a pIMD.
Outcome measures
| Measure |
Co-Ad Group
n=523 Participants
Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=522 Participants
Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study.
|
|---|---|---|
|
Percentage of Participants Reporting at Least One Potential Immune-mediated Disease (pIMDs)
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0.6 Percentage of participants
Interval 0.1 to 1.7
|
Adverse Events
Co-Ad Group
Serious events: 21 serious events
Other events: 427 other events
Deaths: 0 deaths
Control Group
Serious events: 36 serious events
Other events: 428 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Co-Ad Group
n=523 participants at risk
Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=522 participants at risk
Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study.
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
0.38%
2/523 • Number of events 3 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
COVID-19
|
0.38%
2/523 • Number of events 2 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Respiratory tract infection
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Bacterial disease carrier
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Complicated appendicitis
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Infected skin ulcer
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Retroperitoneal abscess
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Septic shock
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Superinfection
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Cardiac disorders
Atrial fibrillation
|
0.38%
2/523 • Number of events 2 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Cardiac disorders
Arrhythmia
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Cardiac disorders
Cardiac failure
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.57%
3/522 • Number of events 5 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.38%
2/522 • Number of events 2 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ocular melanoma
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal neoplasm
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.57%
3/522 • Number of events 3 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Posterior capsule rupture
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Vascular disorders
Giant cell arteritis
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Chest pain
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
Other adverse events
| Measure |
Co-Ad Group
n=523 participants at risk
Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=522 participants at risk
Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study.
|
|---|---|---|
|
General disorders
Vessel puncture site swelling
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Injection site pain
|
70.4%
368/523 • Number of events 368 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
66.9%
349/522 • Number of events 496 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Fatigue
|
45.1%
236/523 • Number of events 237 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
40.6%
212/522 • Number of events 286 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Injection site erythema
|
15.9%
83/523 • Number of events 83 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
14.6%
76/522 • Number of events 84 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Injection site swelling
|
12.8%
67/523 • Number of events 67 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
11.7%
61/522 • Number of events 69 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Pyrexia
|
2.7%
14/523 • Number of events 14 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
1.7%
9/522 • Number of events 9 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Influenza like illness
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.77%
4/522 • Number of events 5 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Administration site erythema
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Administration site pain
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Asthenia
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Chills
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Inflammation
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Injection site haematoma
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Malaise
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Oedema peripheral
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Pain
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
38.4%
201/523 • Number of events 203 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
39.5%
206/522 • Number of events 263 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.4%
133/523 • Number of events 134 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
25.5%
133/522 • Number of events 164 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.57%
3/522 • Number of events 3 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.38%
2/522 • Number of events 2 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Headache
|
31.9%
167/523 • Number of events 167 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
31.4%
164/522 • Number of events 210 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Paraesthesia
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.38%
2/522 • Number of events 2 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Dizziness postural
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Sciatica
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Syncope
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Nasopharyngitis
|
2.5%
13/523 • Number of events 13 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
2.9%
15/522 • Number of events 17 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
COVID-19
|
2.1%
11/523 • Number of events 11 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
2.7%
14/522 • Number of events 14 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Bronchitis
|
0.76%
4/523 • Number of events 4 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.96%
5/522 • Number of events 5 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
1.3%
7/522 • Number of events 7 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.57%
3/523 • Number of events 3 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.77%
4/522 • Number of events 4 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Rhinitis
|
0.38%
2/523 • Number of events 2 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.57%
3/522 • Number of events 3 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Pharyngitis
|
0.38%
2/523 • Number of events 2 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Sinusitis
|
0.38%
2/523 • Number of events 2 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Herpes zoster
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.38%
2/522 • Number of events 2 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Pneumonia
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.38%
2/522 • Number of events 2 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Abscess oral
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Diverticulitis
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Ear infection
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Herpes simplex
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Infected bite
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Localised infection
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Parotitis
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Tooth infection
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
1.1%
6/522 • Number of events 6 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.57%
3/522 • Number of events 3 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.38%
2/522 • Number of events 2 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Fall
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.57%
3/522 • Number of events 3 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.57%
3/522 • Number of events 3 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 2 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Muscle contusion
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.38%
2/522 • Number of events 2 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Odynophagia
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Vomiting
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Vascular disorders
Hypertension
|
0.38%
2/523 • Number of events 2 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.96%
5/522 • Number of events 5 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Vascular disorders
Haematoma
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Eye disorders
Blepharitis
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Eye disorders
Glaucoma
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Eye disorders
Neovascular age-related macular degeneration
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Investigations
Blood pressure increased
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Investigations
Occult blood positive
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Renal and urinary disorders
Haematuria
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/523 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/522 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Psychiatric disorders
Restlessness
|
0.19%
1/523 • Number of events 1 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/522 • Solicited AEs were collected during 7-day follow-up period after each vaccination. Unsolicited AEs were ollected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER