Trial Outcomes & Findings for HIV Vaccine Trial in Thai Adults (NCT NCT00223080)
NCT ID: NCT00223080
Last Updated: 2019-04-24
Results Overview
HIV-1 infection rate. Detection of HIV-1 infection was defined according to the HIV diagnostic algorithm utilizing serologic and nucleic acid technologies. Incidence of HIV infection was compared in the vaccine and placebo-recipient groups.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
16402 participants
Primary outcome timeframe
42 Months
Results posted on
2019-04-24
Participant Flow
16,402 subjects were randomized, 16,395 were infection free and assigned treatment groups
16,402 individuals were randomly assigned to the 2 treatment arms. 7 individuals were identified as having human immunodeficiency virus (HIV) infection that was present pre-vaccination detected by polymerase chain reaction (PCR) amplification. These individuals were removed from the modified intent to treat (MITT) population.
Participant milestones
| Measure |
Vaccine
ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24.
ALVAC-HIV vCP1521 + AIDSVAX: Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL
|
Placebo
ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4.
ALVAC Placebo + AIDSVAX Placebo: ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection
|
|---|---|---|
|
Overall Study
STARTED
|
8197
|
8198
|
|
Overall Study
COMPLETED
|
7401
|
7401
|
|
Overall Study
NOT COMPLETED
|
796
|
797
|
Reasons for withdrawal
| Measure |
Vaccine
ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24.
ALVAC-HIV vCP1521 + AIDSVAX: Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL
|
Placebo
ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4.
ALVAC Placebo + AIDSVAX Placebo: ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
253
|
232
|
|
Overall Study
Required contraindicated med
|
0
|
1
|
|
Overall Study
Non-compliant
|
7
|
7
|
|
Overall Study
Moved from study area
|
37
|
47
|
|
Overall Study
Lost to Follow-up
|
259
|
284
|
|
Overall Study
Death
|
85
|
74
|
|
Overall Study
Other
|
14
|
11
|
|
Overall Study
Reason not provided
|
141
|
140
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
HIV Vaccine Trial in Thai Adults
Baseline characteristics by cohort
| Measure |
Vaccine
n=8197 Participants
ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24.
ALVAC-HIV vCP1521 + AIDSVAX: Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL
|
Placebo
n=8198 Participants
ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4.
ALVAC Placebo + AIDSVAX Placebo: ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection
|
Total
n=16395 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 - 20
|
2297 Participants
n=5 Participants
|
2246 Participants
n=7 Participants
|
4543 Participants
n=5 Participants
|
|
Age, Customized
21 - 25
|
3633 Participants
n=5 Participants
|
3708 Participants
n=7 Participants
|
7341 Participants
n=5 Participants
|
|
Age, Customized
26 - 30
|
2267 Participants
n=5 Participants
|
2244 Participants
n=7 Participants
|
4511 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3164 Participants
n=5 Participants
|
3167 Participants
n=7 Participants
|
6331 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5033 Participants
n=5 Participants
|
5031 Participants
n=7 Participants
|
10064 Participants
n=5 Participants
|
|
Province
Chon Buri
|
4107 participants
n=5 Participants
|
4107 participants
n=7 Participants
|
8214 participants
n=5 Participants
|
|
Province
Rayong
|
4090 participants
n=5 Participants
|
4091 participants
n=7 Participants
|
8181 participants
n=5 Participants
|
|
Marital status
Single
|
3353 participants
n=5 Participants
|
3338 participants
n=7 Participants
|
6691 participants
n=5 Participants
|
|
Marital status
Married
|
4110 participants
n=5 Participants
|
4169 participants
n=7 Participants
|
8279 participants
n=5 Participants
|
|
Marital status
Divorced
|
602 participants
n=5 Participants
|
541 participants
n=7 Participants
|
1143 participants
n=5 Participants
|
|
Marital status
Widowed
|
50 participants
n=5 Participants
|
64 participants
n=7 Participants
|
114 participants
n=5 Participants
|
|
Marital status
Separated
|
82 participants
n=5 Participants
|
86 participants
n=7 Participants
|
168 participants
n=5 Participants
|
|
Number of sex partners
0
|
1864 participants
n=5 Participants
|
1801 participants
n=7 Participants
|
3665 participants
n=5 Participants
|
|
Number of sex partners
1
|
5428 participants
n=5 Participants
|
5495 participants
n=7 Participants
|
10923 participants
n=5 Participants
|
|
Number of sex partners
> 1
|
619 participants
n=5 Participants
|
620 participants
n=7 Participants
|
1239 participants
n=5 Participants
|
|
Number of sex partners
Did not answer
|
280 participants
n=5 Participants
|
273 participants
n=7 Participants
|
553 participants
n=5 Participants
|
|
Number of sex partners
Missing data
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Risk group
Low
|
3865 participants
n=5 Participants
|
3924 participants
n=7 Participants
|
7789 participants
n=5 Participants
|
|
Risk group
Medium
|
2369 participants
n=5 Participants
|
2292 participants
n=7 Participants
|
4661 participants
n=5 Participants
|
|
Risk group
High
|
1963 participants
n=5 Participants
|
1982 participants
n=7 Participants
|
3945 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 42 MonthsPopulation: Modified Intent-to-Treat (MITT) Population: those participants who were infection free at entry into the study
HIV-1 infection rate. Detection of HIV-1 infection was defined according to the HIV diagnostic algorithm utilizing serologic and nucleic acid technologies. Incidence of HIV infection was compared in the vaccine and placebo-recipient groups.
Outcome measures
| Measure |
Vaccine
n=8197 Participants
ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24.
ALVAC-HIV vCP1521 + AIDSVAX: Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL
|
Placebo
n=8198 Participants
ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4.
ALVAC Placebo + AIDSVAX Placebo: ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection
|
|---|---|---|
|
Kaplan-Meier Estimate of HIV-1 Infection Rate in Intent to Treat Population
12 months
|
0.15 Percetage of subjects
Interval 0.07 to 0.24
|
0.38 Percetage of subjects
Interval 0.24 to 0.52
|
|
Kaplan-Meier Estimate of HIV-1 Infection Rate in Intent to Treat Population
24 months
|
0.41 Percetage of subjects
Interval 0.27 to 0.55
|
0.64 Percetage of subjects
Interval 0.46 to 0.82
|
|
Kaplan-Meier Estimate of HIV-1 Infection Rate in Intent to Treat Population
36 months
|
0.58 Percetage of subjects
Interval 0.41 to 0.75
|
0.84 Percetage of subjects
Interval 0.63 to 1.04
|
|
Kaplan-Meier Estimate of HIV-1 Infection Rate in Intent to Treat Population
42 months
|
0.68 Percetage of subjects
Interval 0.49 to 0.87
|
0.96 Percetage of subjects
Interval 0.74 to 1.18
|
PRIMARY outcome
Timeframe: 42 MonthsPopulation: Per-protocol population: The per-protocol analysis is restricted to the individuals who were infection-free at the completion of vaccination and who received a timely set of 4 vaccinations.
Cumulative Number of HIV Infections. Detection of HIV-1 infection was defined according to the HIV diagnostic algorithm utilizing serologic and nucleic acid technologies. Incidence of HIV infection was compared in the vaccine and placebo-recipient groups.
Outcome measures
| Measure |
Vaccine
n=6176 Participants
ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24.
ALVAC-HIV vCP1521 + AIDSVAX: Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL
|
Placebo
n=6366 Participants
ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4.
ALVAC Placebo + AIDSVAX Placebo: ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection
|
|---|---|---|
|
Vaccine Efficacy as Determined by Acquisition of Infection in the Per-protocol Population
12 months
|
0.08 Percentage of subjects
Interval 0.01 to 0.15
|
0.25 Percentage of subjects
Interval 0.13 to 0.38
|
|
Vaccine Efficacy as Determined by Acquisition of Infection in the Per-protocol Population
24 months
|
0.36 Percentage of subjects
Interval 0.21 to 0.51
|
0.49 Percentage of subjects
Interval 0.32 to 0.66
|
|
Vaccine Efficacy as Determined by Acquisition of Infection in the Per-protocol Population
36 months
|
0.52 Percentage of subjects
Interval 0.34 to 0.71
|
0.70 Percentage of subjects
Interval 0.49 to 0.91
|
|
Vaccine Efficacy as Determined by Acquisition of Infection in the Per-protocol Population
42 months
|
0.59 Percentage of subjects
Interval 0.4 to 0.78
|
0.80 Percentage of subjects
Interval 0.58 to 1.02
|
PRIMARY outcome
Timeframe: 42 monthsPopulation: Modified Intent-to-Treat (MITT) Population: those participants who were infection free at entry into the study
Log10 HIV-1 viral loads for diagnostic specimens for subjects with post-HIV infection. The trial quantitated HIV plasma viral load at the time of diagnosis and through the remainder of the follow-up period. Peri infection results were compared in vaccine and placebo recipients who became HIV-infected during the trial.
Outcome measures
| Measure |
Vaccine
n=51 Participants
ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24.
ALVAC-HIV vCP1521 + AIDSVAX: Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL
|
Placebo
n=73 Participants
ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4.
ALVAC Placebo + AIDSVAX Placebo: ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection
|
|---|---|---|
|
Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the MITT Population
First positive serology
|
4.379 log [HIV-1 viral load (unitless)]
Standard Error 0.127
|
4.187 log [HIV-1 viral load (unitless)]
Standard Error 0.101
|
|
Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the MITT Population
3-weeks post identificaiton
|
4.229 log [HIV-1 viral load (unitless)]
Standard Error 0.130
|
4.235 log [HIV-1 viral load (unitless)]
Standard Error 0.095
|
|
Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the MITT Population
~6-weeks post identification
|
4.274 log [HIV-1 viral load (unitless)]
Standard Error 0.125
|
4.167 log [HIV-1 viral load (unitless)]
Standard Error 0.104
|
PRIMARY outcome
Timeframe: 42 monthsPopulation: Per-protocol population: The per-protocol analysis is restricted to the individuals who were infection-free at the completion of vaccination and who received a timely set of 4 vaccinations.
Log10 HIV-1 viral loads for diagnostic specimens for subjects with post-HIV infection. The trial quantitated HIV plasma viral load at the time of diagnosis and through the remainder of the follow-up period. Peri infection results were compared in vaccine and placebo recipients who became HIV-infected during the trial.
Outcome measures
| Measure |
Vaccine
n=36 Participants
ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24.
ALVAC-HIV vCP1521 + AIDSVAX: Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL
|
Placebo
n=50 Participants
ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4.
ALVAC Placebo + AIDSVAX Placebo: ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection
|
|---|---|---|
|
Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the Per Protocol Population
First positive serology
|
4.307 log [HIV-1 viral load (unitless)]
Standard Error 0.154
|
4.153 log [HIV-1 viral load (unitless)]
Standard Error 0.136
|
|
Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the Per Protocol Population
3-weeks post identificaiton
|
4.128 log [HIV-1 viral load (unitless)]
Standard Error 0.161
|
4.276 log [HIV-1 viral load (unitless)]
Standard Error 0.118
|
|
Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the Per Protocol Population
~6-weeks post identification
|
4.280 log [HIV-1 viral load (unitless)]
Standard Error 0.152
|
4.143 log [HIV-1 viral load (unitless)]
Standard Error 0.143
|
SECONDARY outcome
Timeframe: 42 weeksPopulation: Prior to the analysis, the SAP identified the MITT as those participants who were infection free at entry into the study. Although individuals were screened for HIV antibody prior to entry, individuals identified by laboratory examination of PCR assessments of blinded pre-randomization specimens that were performed subsequent to entry were excluded
Two CD4 cell counts were obtained (at the verification blood draw and the notification blood draw) and through the remainder of the follow-up period. Results were compared in vaccine and placebo recipients who became HIV-infected during the trial.
Outcome measures
| Measure |
Vaccine
n=51 Participants
ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24.
ALVAC-HIV vCP1521 + AIDSVAX: Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL
|
Placebo
n=73 Participants
ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4.
ALVAC Placebo + AIDSVAX Placebo: ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection
|
|---|---|---|
|
Changes in CD4 T Cell Count in Volunteers Who Developed HIV Infection During the Trial for MITT Population
1st verification
|
565.4 cells / µL
Standard Error 43.5
|
566.7 cells / µL
Standard Error 26.5
|
|
Changes in CD4 T Cell Count in Volunteers Who Developed HIV Infection During the Trial for MITT Population
Notification
|
539.6 cells / µL
Standard Error 37.1
|
570.6 cells / µL
Standard Error 29.2
|
SECONDARY outcome
Timeframe: Dose Interval 1: week 0, Dose Interval 2: Week 4, Dose Interval 3: Week 12, and Dose Interval 4: Week 24; every 6 months during 3 year f/u periodPopulation: intent-to-treat population
The intent-to-treat population is used for analysis of AEs and treatment emergent events are reported. Participant AE rates for all AEs, SAEs and treatment-related AEs are summarized
Outcome measures
| Measure |
Vaccine
n=8197 Participants
ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24.
ALVAC-HIV vCP1521 + AIDSVAX: Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL
|
Placebo
n=8198 Participants
ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4.
ALVAC Placebo + AIDSVAX Placebo: ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection
|
|---|---|---|
|
Safety Assessment (SAE's and AEs)
30-day post dose interval 1
|
1277 adverse events
|
1336 adverse events
|
|
Safety Assessment (SAE's and AEs)
30-day post dose interval 2
|
816 adverse events
|
860 adverse events
|
|
Safety Assessment (SAE's and AEs)
30-day post dose interval 3
|
614 adverse events
|
597 adverse events
|
|
Safety Assessment (SAE's and AEs)
30-day post dose interval 4
|
599 adverse events
|
630 adverse events
|
|
Safety Assessment (SAE's and AEs)
All treatment emergent
|
5627 adverse events
|
5685 adverse events
|
SECONDARY outcome
Timeframe: Week 182Population: Prior to the analysis, the SAP identified the MITT as those participants who were infection free at entry into the study. Although individuals were screened for HIV antibody prior to entry, individuals identified by laboratory examination of PCR assessments of blinded pre-randomization specimens that were performed subsequent to entry were excluded
Self Report of Risk Behavior Status by Treatment and Time. Specifically, this is the responses to the question "Do you think that your everyday behavior puts you at risk for HIV infection?" Modified intent to treat population (MITT)
Outcome measures
| Measure |
Vaccine
n=7399 Participants
ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24.
ALVAC-HIV vCP1521 + AIDSVAX: Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL
|
Placebo
n=7395 Participants
ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4.
ALVAC Placebo + AIDSVAX Placebo: ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection
|
|---|---|---|
|
Change in HIV Risk Behaviors Associated With Participation in the Vaccine Trial (MITT)
Yes
|
702 participants
|
763 participants
|
|
Change in HIV Risk Behaviors Associated With Participation in the Vaccine Trial (MITT)
No
|
6223 participants
|
6130 participants
|
|
Change in HIV Risk Behaviors Associated With Participation in the Vaccine Trial (MITT)
Don't know/Not sure
|
473 participants
|
502 participants
|
|
Change in HIV Risk Behaviors Associated With Participation in the Vaccine Trial (MITT)
Missing value
|
1 participants
|
0 participants
|
Adverse Events
Vaccine
Serious events: 1175 serious events
Other events: 7442 other events
Deaths: 85 deaths
Placebo
Serious events: 1219 serious events
Other events: 6141 other events
Deaths: 75 deaths
Serious adverse events
| Measure |
Vaccine
n=8197 participants at risk
ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24.
ALVAC-HIV vCP1521 + AIDSVAX: Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL
|
Placebo
n=8198 participants at risk
ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4.
ALVAC Placebo + AIDSVAX Placebo: ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiocentric lymphoma stage II
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchioloalveolar carcinoma
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Germ cell cancer
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasopharyngeal cancer
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma stage II
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Blood and lymphatic system disorders
Anaemia of pregnancy
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Blood and lymphatic system disorders
Autoimmune thrombocytopenia
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Cardiac disorders
Arrhythmia
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Cardiac disorders
Cardiac failure
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Cardiac disorders
Cardiac valve disease
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Cardiac disorders
Cardiomegaly
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Cardiac disorders
Extrasystoles
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Cardiac disorders
Mitral valve stenosis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Cardiac disorders
Myocarditis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Cardiac disorders
Wolff-Parkinson-White syndrome
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Congenital, familial and genetic disorders
Cleft lip
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Congenital, familial and genetic disorders
Cleft lip and palate
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Congenital, familial and genetic disorders
Cleft palate
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Congenital, familial and genetic disorders
Congenital anomaly
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Congenital, familial and genetic disorders
Congenital heart valve disorder
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Congenital, familial and genetic disorders
Congenital inguinal hernia
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Congenital, familial and genetic disorders
Congenital megacolon
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Congenital, familial and genetic disorders
Congenital skin disorder
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Congenital, familial and genetic disorders
Ebstein's anomaly
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Congenital, familial and genetic disorders
Familial periodic paralysis
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Congenital, familial and genetic disorders
Foetal cystic hygroma
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Congenital, familial and genetic disorders
Glucose-6-phosphate dehydrogenase deficiency
|
0.06%
5/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Congenital, familial and genetic disorders
Limb malformation
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Congenital, familial and genetic disorders
Multiple congenital abnormalities
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Congenital, familial and genetic disorders
Polydactyly
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Congenital, familial and genetic disorders
Thyroglossal cyst
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Congenital, familial and genetic disorders
Transposition of the great vessels
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Congenital, familial and genetic disorders
Trisomy 21
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Congenital, familial and genetic disorders
Urachal abnormality
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Congenital, familial and genetic disorders
Ventricular septal defect
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Ear and labyrinth disorders
Auricular perichondritis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Ear and labyrinth disorders
Vertigo
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Endocrine disorders
Goitre
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Endocrine disorders
Hyperthyroidism
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Endocrine disorders
Thyrotoxic crisis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Endocrine disorders
Thyrotoxic periodic paralysis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Eye disorders
Photokeratitis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Eye disorders
Ulcerative keratitis
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Abdominal pain
|
0.10%
8/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.09%
7/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Anal polyp
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Appendicitis perforated
|
0.10%
8/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.06%
5/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Diarrhoea
|
0.10%
8/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.15%
12/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.04%
3/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Dyspepsia
|
0.16%
13/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.18%
15/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Enteritis
|
0.05%
4/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.04%
3/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Food poisoning
|
0.05%
4/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Gastritis
|
0.12%
10/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.17%
14/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Gastritis alcoholic
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Gastritis alcoholic haemorrhagic
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Gastroduodenitis haemorrhagic
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.04%
3/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.04%
3/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Ileus
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.12%
10/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.12%
10/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.05%
4/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.07%
6/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.10%
8/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Peptic ulcer perforation
|
0.05%
4/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.06%
5/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.07%
6/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Volvulus
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Gastrointestinal disorders
Vomiting
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Chest pain
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Death
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Drowning
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.05%
4/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Electrocution
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Fatigue
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Foreign body reaction
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Lipogranuloma
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Pyrexia
|
0.09%
7/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.17%
14/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Sudden death
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Cholangitis acute
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Cholecystitis acute
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Cholecystitis chronic
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Cholelithiasis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Gallbladder polyp
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Hepatitis
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Hepatitis alcoholic
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Hepatitis fulminant
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Jaundice cholestatic
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Post cholecystectomy syndrome
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Immune system disorders
Allergy to arthropod bite
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Immune system disorders
Allergy to arthropod sting
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.05%
4/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Immune system disorders
Anaphylactic reaction
|
0.05%
4/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.05%
4/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Immune system disorders
Drug hypersensitivity
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Immune system disorders
Food allergy
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Immune system disorders
Immune reconstitution syndrome
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Abortion infected
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Abscess
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Abscess jaw
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Abscess limb
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Abscess neck
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Abscess oral
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Acute sinusitis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Acute tonsillitis
|
0.07%
6/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.12%
10/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Amoebic dysentery
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Anal abscess
|
0.04%
3/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Anogenital warts
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Appendicitis
|
0.66%
54/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.74%
61/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Bacteraemia
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Bacterial labyrinthitis
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Bartholin's abscess
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Breast abscess
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Bronchitis
|
0.09%
7/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.13%
11/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Cellulitis
|
0.05%
4/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.07%
6/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Chronic tonsillitis
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Cystitis
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.04%
3/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Dengue fever
|
0.70%
57/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.55%
45/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Dermatitis infected
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Diarrhoea infectious
|
0.05%
4/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Disseminated tuberculosis
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Endocarditis
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Endometritis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Endometritis decidual
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Gastroenteritis
|
0.23%
19/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.27%
22/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Giardiasis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Hepatitis A
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Hepatitis B
|
0.05%
4/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.04%
3/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Hepatitis viral
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Hookworm infection
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Infected bites
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Infected cyst
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Infected skin ulcer
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Infection
|
0.04%
3/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Infection in an immunocompromised host
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Influenza
|
0.04%
3/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.13%
11/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Leptospirosis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Liver abscess
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Lobar pneumonia
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Lymph node tuberculosis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Malaria
|
0.05%
4/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Measles
|
0.05%
4/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Meningitis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Meningitis aseptic
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Meningitis bacterial
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Meningitis tuberculous
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Meningitis viral
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Mumps
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Murine typhus
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Muscle abscess
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Nasopharyngitis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Orchitis
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Osteomyelitis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Osteomyelitis chronic
|
0.05%
4/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Paronychia
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.17%
14/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.15%
12/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Perineal infection
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Peritonsillar abscess
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Pharyngitis
|
0.29%
24/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.24%
20/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Pharyngotonsillitis
|
0.05%
4/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Plasmodium falciparum infection
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.04%
3/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Pneumonia
|
0.12%
10/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.11%
9/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Pneumonia measles
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Pneumonia primary atypical
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Post procedural infection
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.04%
3/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Postoperative wound infection
|
0.04%
3/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.04%
3/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.05%
4/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Pyelonephritis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Pyelonephritis acute
|
0.17%
14/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.32%
26/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Pyomyositis
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Rickettsiosis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Rubella
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Salmonellosis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Salpingitis
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Scrub typhus
|
0.05%
4/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Sepsis
|
0.06%
5/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.05%
4/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Sialoadenitis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Sinusitis
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Tonsillitis
|
0.13%
11/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.09%
7/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Tooth abscess
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Tuberculous pleurisy
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Typhoid fever
|
0.04%
3/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.04%
3/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Upper respiratory tract infection
|
0.07%
6/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.18%
15/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Urinary tract infection
|
0.17%
14/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.20%
16/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Vaginal cellulitis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Varicella
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Viral infection
|
0.12%
10/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.16%
13/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Viral skin infection
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Wound infection
|
0.06%
5/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.10%
8/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Accident
|
0.29%
24/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.27%
22/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Accident at home
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Accident at work
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.04%
3/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Cataract traumatic
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Caustic injury
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Chemical eye injury
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Chemical injury
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Chemical poisoning
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.06%
5/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Concussion
|
0.07%
6/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.07%
6/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Contusion
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Crushing injury of trunk
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Electric shock
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Eye penetration
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Face injury
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.04%
3/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.05%
4/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Fall
|
0.17%
14/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.09%
7/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.24%
20/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.26%
21/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.05%
4/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Head injury
|
0.05%
4/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.07%
6/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Induced abortion haemorrhage
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Injury
|
0.07%
6/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.18%
15/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.05%
4/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Laceration
|
0.04%
3/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.04%
3/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Medical device complication
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.11%
9/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.15%
12/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.04%
3/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Near drowning
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Open fracture
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Open wound
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Overdose
|
0.07%
6/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.09%
7/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Penetrating abdominal trauma
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Peripheral nerve injury
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Poisoning deliberate
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.06%
5/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.04%
3/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Renal injury
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
3.9%
322/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
3.9%
318/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Sciatic nerve injury
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.04%
3/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.06%
5/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Snake bite
|
0.11%
9/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.10%
8/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Sports injury
|
0.04%
3/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.05%
4/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.04%
3/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Testicular injury
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Traumatic shock
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Ulna fracture
|
0.05%
4/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Infections and infestations
Urinary bladder rupture
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Metabolism and nutrition disorders
Gestational diabetes
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.04%
3/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired in pregnancy
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.04%
3/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Musculoskeletal and connective tissue disorders
Fracture delayed union
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Musculoskeletal and connective tissue disorders
Fracture malunion
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Musculoskeletal and connective tissue disorders
Spondylolysis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of the cervix
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma metastatic
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Nervous system disorders
Alcoholic seizure
|
0.04%
3/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Nervous system disorders
Cerebral infarction
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Nervous system disorders
Convulsion
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Nervous system disorders
Demyelination
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Nervous system disorders
Dizziness
|
0.04%
3/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Nervous system disorders
Encephalitis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Nervous system disorders
Epilepsy
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Nervous system disorders
Headache
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.04%
3/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Nervous system disorders
Migraine
|
0.06%
5/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.04%
3/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Nervous system disorders
Myelitis transverse
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Nervous system disorders
Paraplegia
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Nervous system disorders
Post-traumatic epilepsy
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Nervous system disorders
Syncope
|
0.04%
3/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Nervous system disorders
Tension headache
|
0.05%
4/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Nervous system disorders
Vascular headache
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Abortion complete
|
0.12%
10/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.20%
16/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Abortion incomplete
|
0.16%
13/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.12%
10/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Abortion incomplete complicated
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.04%
3/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.89%
73/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.66%
54/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous complete
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous incomplete
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Abortion threatened
|
0.05%
4/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.05%
4/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Arrested labour
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Blighted ovum
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Breech presentation
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Cephalo-pelvic disproportion
|
0.07%
6/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.09%
7/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Complication of pregnancy
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Eclampsia
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.04%
3/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.15%
12/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
False labour
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.05%
4/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Foetal distress syndrome
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Foetal growth retardation
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Hydrops foetalis
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Hyperemesis gravidarum
|
0.12%
10/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.16%
13/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Intra-uterine death
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Labour complication
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Obstructed labour
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Oligohydramnios
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Placenta praevia
|
0.06%
5/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.06%
5/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Polyhydramnios
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Post abortion haemorrhage
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum haemorrhage
|
0.06%
5/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.09%
7/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.15%
12/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.15%
12/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy induced hypertension
|
0.07%
6/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.06%
5/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
0.06%
5/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.04%
3/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Premature rupture of membranes
|
0.06%
5/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.15%
12/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Premature separation of placenta
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Prolonged labour
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Prolonged pregnancy
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Retained placenta or membranes
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Ruptured ectopic pregnancy
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
0.04%
3/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.05%
4/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Third stage postpartum haemorrhage
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Threatened labour
|
0.07%
6/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.11%
9/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Pregnancy, puerperium and perinatal conditions
Umbilical cord prolapse
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Psychiatric disorders
Completed suicide
|
0.12%
10/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.07%
6/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Psychiatric disorders
Depression
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Psychiatric disorders
Major depression
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Psychiatric disorders
Psychotic disorder
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Psychiatric disorders
Schizophrenia
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Psychiatric disorders
Schizophrenia, paranoid type
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.04%
3/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Psychiatric disorders
Suicide attempt
|
0.29%
24/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.28%
23/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Renal and urinary disorders
Calculus ureteric
|
0.05%
4/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Renal and urinary disorders
Calculus urinary
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.04%
3/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.04%
3/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Renal and urinary disorders
Renal failure
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Renal and urinary disorders
Renal failure acute
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Renal and urinary disorders
Stag horn calculus
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.04%
3/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Reproductive system and breast disorders
Endometriosis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.02%
2/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.04%
3/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.04%
3/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Reproductive system and breast disorders
Ovarian cyst torsion
|
0.04%
3/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Reproductive system and breast disorders
Ovarian mass
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Reproductive system and breast disorders
Prostatitis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Reproductive system and breast disorders
Varicocele
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.07%
6/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.06%
5/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.04%
3/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.06%
5/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.04%
3/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.05%
4/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Skin and subcutaneous tissue disorders
Pemphigus
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Skin and subcutaneous tissue disorders
Pityriasis
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.05%
4/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.02%
2/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Social circumstances
Physical assault
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Surgical and medical procedures
Abortion induced
|
0.04%
3/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.06%
5/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Surgical and medical procedures
Caesarean section
|
0.00%
0/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.01%
1/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Surgical and medical procedures
Endometriosis ablation
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Vascular disorders
Hypovolaemic shock
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Vascular disorders
Varicose vein
|
0.01%
1/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
0.00%
0/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
Other adverse events
| Measure |
Vaccine
n=8197 participants at risk
ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24.
ALVAC-HIV vCP1521 + AIDSVAX: Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL
|
Placebo
n=8198 participants at risk
ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4.
ALVAC Placebo + AIDSVAX Placebo: ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection
|
|---|---|---|
|
General disorders
Headache
|
44.9%
3677/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
30.8%
2522/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Fatigue
|
63.2%
5182/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
41.6%
3410/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Nausea/Vomiting
|
12.6%
1030/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
9.8%
802/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Myalgia
|
51.7%
4237/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
30.4%
2494/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Arthralgia
|
26.6%
2177/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
15.2%
1246/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.2%
266/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
3.3%
273/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Oral Temperature
|
19.1%
1564/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
12.3%
1009/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Pain/Tenderness
|
43.2%
3543/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
36.5%
2991/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Swelling
|
7.8%
643/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
4.6%
379/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Arm Movement Limitation
|
32.0%
2627/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
23.7%
1943/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Induration
|
3.9%
316/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
1.3%
108/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
|
General disorders
Erythema
|
3.5%
283/8197 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
2.2%
177/8198 • For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
|
Additional Information
Dr. Supachai Rerks-Ngarm
Department of Disease Control, Ministry of Public Health
Phone: 66-2-590-3006
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place