Trial Outcomes & Findings for Safety & Immunogenicity of 13vPnC in HIV-Infected Subjects Aged 18 or Older Who Were Previously Immunized With 23vPS (NCT NCT00963235)
NCT ID: NCT00963235
Last Updated: 2013-06-10
Results Overview
Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
331 participants
Primary outcome timeframe
1 month post-dose 2, 1 month post-dose 3
Results posted on
2013-06-10
Participant Flow
Participant milestones
| Measure |
13vPnC
Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
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Overall Study
STARTED
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331
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Overall Study
Vaccinated Dose 1
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329
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Overall Study
Vaccinated Dose 2
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300
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Overall Study
Vaccinated Dose 3
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279
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Overall Study
Completed Dose 3 1-month Blood Draw
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277
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Overall Study
COMPLETED
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271
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Overall Study
NOT COMPLETED
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60
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Reasons for withdrawal
| Measure |
13vPnC
Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
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Overall Study
Withdrawal by Subject
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22
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Overall Study
Lost to Follow-up
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14
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Overall Study
Failed to return
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9
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Overall Study
Protocol Violation
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7
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Overall Study
Adverse Event
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5
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Overall Study
Physician Decision
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2
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Overall Study
Other
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1
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Baseline Characteristics
Safety & Immunogenicity of 13vPnC in HIV-Infected Subjects Aged 18 or Older Who Were Previously Immunized With 23vPS
Baseline characteristics by cohort
| Measure |
13vPnC
n=329 Participants
Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
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Age Continuous
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47.3 years
STANDARD_DEVIATION 9.10 • n=5 Participants
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Sex: Female, Male
Female
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66 Participants
n=5 Participants
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Sex: Female, Male
Male
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263 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 1 month post-dose 2, 1 month post-dose 3Population: Evaluable immunogenicity population: eligible participants who were \>=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.
Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
Outcome measures
| Measure |
13vPnC
n=223 Participants
Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
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Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Serotype 1
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0.94 fold rise
Interval 0.88 to 1.01
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Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Serotype 3
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1.01 fold rise
Interval 0.95 to 1.08
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Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Serotype 4
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1.01 fold rise
Interval 0.94 to 1.08
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Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Serotype 5
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0.99 fold rise
Interval 0.94 to 1.05
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Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Serotype 6A
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1.19 fold rise
Interval 1.11 to 1.27
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Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Serotype 6B
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1.21 fold rise
Interval 1.13 to 1.31
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Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Serotype 7F
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1.07 fold rise
Interval 1.0 to 1.14
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Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Serotype 9V
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1.08 fold rise
Interval 1.02 to 1.15
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Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Serotype 14
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1.08 fold rise
Interval 0.99 to 1.17
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Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Serotype 18C
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1.09 fold rise
Interval 1.02 to 1.16
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Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Serotype 19A
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1.03 fold rise
Interval 0.98 to 1.09
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Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Serotype 19F
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1.17 fold rise
Interval 1.08 to 1.27
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Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Serotype 23F
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1.25 fold rise
Interval 1.15 to 1.37
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SECONDARY outcome
Timeframe: 1 month post-dose 2, 1 month post-dose 3Population: Evaluable immunogenicity population: eligible participants who were \>=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means (GMs) were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.
Outcome measures
| Measure |
13vPnC
n=223 Participants
Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 1: Dose 2
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2.31 microgram per milliliter (mcg/mL)
Interval 1.97 to 2.72
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 1: Dose 3
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2.18 microgram per milliliter (mcg/mL)
Interval 1.88 to 2.54
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 3: Dose 2
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0.54 microgram per milliliter (mcg/mL)
Interval 0.47 to 0.62
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 3: Dose 3
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0.55 microgram per milliliter (mcg/mL)
Interval 0.47 to 0.63
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 4: Dose 2
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1.62 microgram per milliliter (mcg/mL)
Interval 1.41 to 1.87
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 4: Dose 3
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1.63 microgram per milliliter (mcg/mL)
Interval 1.42 to 1.88
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 5: Dose 2
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3.26 microgram per milliliter (mcg/mL)
Interval 2.79 to 3.8
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 5: Dose 3
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3.23 microgram per milliliter (mcg/mL)
Interval 2.78 to 3.75
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 6A: Dose 2
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3.86 microgram per milliliter (mcg/mL)
Interval 3.2 to 4.66
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 6A: Dose 3
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4.60 microgram per milliliter (mcg/mL)
Interval 3.85 to 5.5
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 6B: Dose 2
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4.49 microgram per milliliter (mcg/mL)
Interval 3.7 to 5.46
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 6B: Dose 3
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5.45 microgram per milliliter (mcg/mL)
Interval 4.53 to 6.57
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 7F: Dose 2
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3.40 microgram per milliliter (mcg/mL)
Interval 2.95 to 3.92
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 7F: Dose 3
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3.62 microgram per milliliter (mcg/mL)
Interval 3.17 to 4.14
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 9V: Dose 2
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2.95 microgram per milliliter (mcg/mL)
Interval 2.56 to 3.41
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 9V: Dose 3
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3.20 microgram per milliliter (mcg/mL)
Interval 2.79 to 3.66
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 14: Dose 2
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7.57 microgram per milliliter (mcg/mL)
Interval 6.27 to 9.15
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 14: Dose 3
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8.16 microgram per milliliter (mcg/mL)
Interval 6.87 to 9.69
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 18C: Dose 2
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2.75 microgram per milliliter (mcg/mL)
Interval 2.33 to 3.24
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 18C: Dose 3
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2.99 microgram per milliliter (mcg/mL)
Interval 2.56 to 3.5
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 19A: Dose 2
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7.57 microgram per milliliter (mcg/mL)
Interval 6.54 to 8.76
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 19A: Dose 3
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7.80 microgram per milliliter (mcg/mL)
Interval 6.82 to 8.93
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 19F: Dose 2
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5.73 microgram per milliliter (mcg/mL)
Interval 4.73 to 6.95
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 19F: Dose 3
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6.70 microgram per milliliter (mcg/mL)
Interval 5.61 to 8.01
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 23F: Dose 2
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3.80 microgram per milliliter (mcg/mL)
Interval 3.17 to 4.57
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 23F: Dose 3
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4.77 microgram per milliliter (mcg/mL)
Interval 4.01 to 5.67
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SECONDARY outcome
Timeframe: 1 month post-dose 1, 1 month post-dose 2Population: Evaluable immunogenicity population: eligible participants who were \>=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 1 and post-dose 2 blood draws.
Outcome measures
| Measure |
13vPnC
n=242 Participants
Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 1: Dose 1
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2.15 mcg/mL
Interval 1.8 to 2.57
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 1: Dose 2
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2.36 mcg/mL
Interval 2.03 to 2.75
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 3: Dose 1
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0.48 mcg/mL
Interval 0.41 to 0.56
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 3: Dose 2
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0.57 mcg/mL
Interval 0.49 to 0.65
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 4: Dose 1
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1.37 mcg/mL
Interval 1.15 to 1.64
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 4: Dose 2
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1.64 mcg/mL
Interval 1.43 to 1.89
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 5: Dose 1
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2.90 mcg/mL
Interval 2.48 to 3.4
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 5: Dose 2
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3.29 mcg/mL
Interval 2.83 to 3.81
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 6A: Dose 1
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2.80 mcg/mL
Interval 2.28 to 3.43
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 6A: Dose 2
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3.86 mcg/mL
Interval 3.23 to 4.62
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 6B: Dose 1
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2.90 mcg/mL
Interval 2.36 to 3.57
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 6B: Dose 2
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4.47 mcg/mL
Interval 3.72 to 5.38
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 7F: Dose 1
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3.45 mcg/mL
Interval 2.91 to 4.11
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 7F: Dose 2
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3.41 mcg/mL
Interval 2.99 to 3.9
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 9V: Dose 1
|
2.63 mcg/mL
Interval 2.25 to 3.07
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 9V: Dose 2
|
2.99 mcg/mL
Interval 2.62 to 3.42
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 14: Dose 1
|
6.18 mcg/mL
Interval 4.97 to 7.68
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 14: Dose 2
|
7.60 mcg/mL
Interval 6.35 to 9.09
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 18C: Dose 1
|
2.87 mcg/mL
Interval 2.37 to 3.48
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 18C: Dose 2
|
2.68 mcg/mL
Interval 2.29 to 3.13
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 19A: Dose 1
|
6.53 mcg/mL
Interval 5.54 to 7.69
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 19A: Dose 2
|
7.63 mcg/mL
Interval 6.65 to 8.74
|
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 19F: Dose 1
|
2.75 mcg/mL
Interval 2.18 to 3.49
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 19F: Dose 2
|
5.70 mcg/mL
Interval 4.75 to 6.84
|
|
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 23F: Dose 1
|
2.62 mcg/mL
Interval 2.11 to 3.25
|
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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 23F: Dose 2
|
3.82 mcg/mL
Interval 3.21 to 4.56
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SECONDARY outcome
Timeframe: 1 month post-dose 2, 1 month post-dose 3Population: Evaluable immunogenicity population: eligible participants who were \>=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.
Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.
Outcome measures
| Measure |
13vPnC
n=219 Participants
Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
|
|---|---|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 1: Dose 2
|
41 titers
Interval 32.6 to 50.9
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 1: Dose 3
|
49 titers
Interval 40.1 to 61.0
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 3: Dose 2
|
44 titers
Interval 36.9 to 52.4
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 3: Dose 3
|
56 titers
Interval 47.5 to 66.3
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 4: Dose 2
|
703 titers
Interval 567.6 to 870.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 4: Dose 3
|
724 titers
Interval 585.2 to 896.6
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 5: Dose 2
|
67 titers
Interval 51.9 to 86.1
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 5: Dose 3
|
74 titers
Interval 57.6 to 94.2
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 6A: Dose 2
|
1780 titers
Interval 1392.7 to 2274.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 6A: Dose 3
|
2139 titers
Interval 1709.0 to 2678.3
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 6B: Dose 2
|
1857 titers
Interval 1509.8 to 2284.3
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 6B: Dose 3
|
2447 titers
Interval 2011.9 to 2977.3
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 7F: Dose 2
|
942 titers
Interval 778.6 to 1139.6
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 7F: Dose 3
|
1041 titers
Interval 846.5 to 1279.4
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 9V: Dose 2
|
657 titers
Interval 482.7 to 893.4
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 9V: Dose 3
|
922 titers
Interval 696.0 to 1221.7
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 14: Dose 2
|
746 titers
Interval 614.8 to 905.8
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 14: Dose 3
|
819 titers
Interval 684.7 to 978.8
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 18C: Dose 2
|
521 titers
Interval 383.9 to 706.2
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 18C: Dose 3
|
692 titers
Interval 516.2 to 927.7
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 19A: Dose 2
|
401 titers
Interval 340.2 to 473.0
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 19A: Dose 3
|
419 titers
Interval 358.2 to 490.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 19F: Dose 2
|
269 titers
Interval 202.3 to 357.3
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 19F: Dose 3
|
245 titers
Interval 184.2 to 325.8
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 23F: Dose 2
|
293 titers
Interval 217.2 to 395.0
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC
Serotype 23F: Dose 3
|
393 titers
Interval 295.0 to 522.7
|
SECONDARY outcome
Timeframe: 1 month post-dose 1, 1 month post-dose 2Population: Evaluable immunogenicity population: eligible participants who were \>=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.
Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.
Outcome measures
| Measure |
13vPnC
n=241 Participants
Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
|
|---|---|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 1: Dose 1
|
40 titers
Interval 32.2 to 50.2
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 1: Dose 2
|
40 titers
Interval 32.6 to 49.7
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 3: Dose 1
|
29 titers
Interval 24.0 to 34.9
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 3: Dose 2
|
43 titers
Interval 36.4 to 51.4
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 4: Dose 1
|
622 titers
Interval 478.8 to 806.9
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 4: Dose 2
|
695 titers
Interval 568.1 to 850.7
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 5: Dose 1
|
66 titers
Interval 51.2 to 85.7
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 5: Dose 2
|
65 titers
Interval 50.8 to 82.1
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 6A: Dose 1
|
976 titers
Interval 710.3 to 1342.0
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 6A: Dose 2
|
1687 titers
Interval 1317.2 to 2159.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 6B: Dose 1
|
1088 titers
Interval 806.0 to 1468.4
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 6B: Dose 2
|
1789 titers
Interval 1443.4 to 2216.8
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 7F: Dose 1
|
786 titers
Interval 606.6 to 1018.0
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 7F: Dose 2
|
927 titers
Interval 763.6 to 1125.2
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 9V: Dose 1
|
423 titers
Interval 300.6 to 594.1
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 9V: Dose 2
|
695 titers
Interval 518.3 to 932.0
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 14: Dose 1
|
640 titers
Interval 509.2 to 805.7
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 14: Dose 2
|
723 titers
Interval 602.4 to 867.2
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 18C: Dose 1
|
475 titers
Interval 338.5 to 665.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 18C: Dose 2
|
562 titers
Interval 421.7 to 748.9
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 19A: Dose 1
|
299 titers
Interval 239.7 to 372.2
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 19A: Dose 2
|
391 titers
Interval 333.2 to 458.6
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 19F: Dose 1
|
132 titers
Interval 93.6 to 185.0
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 19F: Dose 2
|
247 titers
Interval 189.3 to 322.9
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 23F: Dose 1
|
92 titers
Interval 65.6 to 127.9
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC
Serotype 23F: Dose 2
|
269 titers
Interval 201.3 to 360.7
|
SECONDARY outcome
Timeframe: 1 month post-dose 2, 1 month post-dose 3Population: Evaluable immunogenicity population: eligible participants who were \>=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.
GMFRs for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
Outcome measures
| Measure |
13vPnC
n=219 Participants
Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
|
|---|---|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Serotype 1
|
1.2 fold rise
Interval 1.06 to 1.39
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Serotype 3
|
1.3 fold rise
Interval 1.13 to 1.44
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Serotype 4
|
1.0 fold rise
Interval 0.9 to 1.18
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Serotype 5
|
1.1 fold rise
Interval 0.95 to 1.28
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Serotype 6A
|
1.2 fold rise
Interval 1.04 to 1.39
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Serotype 6B
|
1.3 fold rise
Interval 1.16 to 1.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Serotype 7F
|
1.1 fold rise
Interval 0.95 to 1.28
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Serotype 9V
|
1.4 fold rise
Interval 1.09 to 1.81
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Serotype 14
|
1.1 fold rise
Interval 0.97 to 1.24
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Serotype 18C
|
1.3 fold rise
Interval 1.1 to 1.6
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Serotype 19A
|
1.0 fold rise
Interval 0.95 to 1.15
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Serotype 19F
|
0.9 fold rise
Interval 0.76 to 1.09
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC
Serotype 23F
|
1.3 fold rise
Interval 1.16 to 1.56
|
SECONDARY outcome
Timeframe: 1 month post-dose 1, 1 month post-dose 2Population: Evaluable immunogenicity population: eligible participants who were \>=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.
GMFRs for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 1 to 1 month post-dose 2 were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
Outcome measures
| Measure |
13vPnC
n=241 Participants
Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
|
|---|---|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnC
Serotype 1
|
1.0 fold rise
Interval 0.84 to 1.2
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnC
Serotype 3
|
1.5 fold rise
Interval 1.29 to 1.73
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnC
Serotype 4
|
1.1 fold rise
Interval 0.92 to 1.36
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnC
Serotype 5
|
1.0 fold rise
Interval 0.79 to 1.2
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnC
Serotype 6A
|
1.7 fold rise
Interval 1.39 to 2.15
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnC
Serotype 6B
|
1.6 fold rise
Interval 1.34 to 2.02
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnC
Serotype 7F
|
1.2 fold rise
Interval 0.96 to 1.45
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnC
Serotype 9V
|
1.6 fold rise
Interval 1.26 to 2.14
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnC
Serotype 14
|
1.1 fold rise
Interval 0.98 to 1.3
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnC
Serotype 18C
|
1.2 fold rise
Interval 0.95 to 1.47
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnC
Serotype 19A
|
1.3 fold rise
Interval 1.15 to 1.5
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnC
Serotype 19F
|
1.9 fold rise
Interval 1.48 to 2.39
|
|
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnC
Serotype 23F
|
2.9 fold rise
Interval 2.29 to 3.77
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 14 days post-dose 1Population: Safety population:participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants whose response was "Yes" for any day or "No" for all days. 'n' = participants whose response was "Yes" for any day or "No" for all days for specified local reaction. Participants may be represented in more than 1 category.
Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters \[cm\]); Moderate (5.5 to 10.0 cm); Severe (greater than \[\>\] 10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).
Outcome measures
| Measure |
13vPnC
n=261 Participants
Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
|
|---|---|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Redness: any (n = 162)
|
5.6 percentage of participants
Interval 2.6 to 10.3
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Redness: mild (n = 161)
|
4.3 percentage of participants
Interval 1.8 to 8.8
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Redness: moderate (n = 158)
|
1.3 percentage of participants
Interval 0.2 to 4.5
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Redness: severe (n = 157)
|
0.0 percentage of participants
Interval 0.0 to 2.3
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Swelling: any (n = 162)
|
6.8 percentage of participants
Interval 3.4 to 11.8
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Swelling: mild (n = 161)
|
6.2 percentage of participants
Interval 3.0 to 11.1
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Swelling: moderate (n = 158)
|
0.6 percentage of participants
Interval 0.0 to 3.5
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Swelling: severe (n = 158)
|
0.6 percentage of participants
Interval 0.0 to 3.5
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Pain: any (n = 260)
|
78.8 percentage of participants
Interval 73.4 to 83.6
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Pain: mild (n = 258)
|
76.4 percentage of participants
Interval 70.7 to 81.4
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Pain: moderate (n = 173)
|
18.5 percentage of participants
Interval 13.0 to 25.1
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1
Pain: severe (n = 158)
|
1.3 percentage of participants
Interval 0.2 to 4.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 14 days post-dose 2Population: Safety population:participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants whose response was "Yes" for any day or "No" for all days. 'n' = participants whose response was "Yes" for any day or "No" for all days for specified local reaction. Participants may be represented in more than 1 category.
Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm); Moderate (5.5 to 10.0 cm); Severe (\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).
Outcome measures
| Measure |
13vPnC
n=238 Participants
Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
|
|---|---|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Redness: any (n = 122)
|
8.2 percentage of participants
Interval 4.0 to 14.6
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Redness: mild (n = 120)
|
6.7 percentage of participants
Interval 2.9 to 12.7
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Redness: moderate (n = 117)
|
1.7 percentage of participants
Interval 0.2 to 6.0
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Redness: severe (n = 117)
|
1.7 percentage of participants
Interval 0.2 to 6.0
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Swelling: any (n = 126)
|
12.7 percentage of participants
Interval 7.4 to 19.8
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Swelling: mild (n = 125)
|
12.0 percentage of participants
Interval 6.9 to 19.0
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Swelling: moderate (n = 116)
|
0.9 percentage of participants
Interval 0.0 to 4.7
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Swelling: severe (n = 117)
|
1.7 percentage of participants
Interval 0.2 to 6.0
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Pain: any (n = 237)
|
81.4 percentage of participants
Interval 75.9 to 86.2
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Pain: mild (n = 230)
|
78.7 percentage of participants
Interval 72.8 to 83.8
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Pain: moderate (n = 150)
|
33.3 percentage of participants
Interval 25.9 to 41.5
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2
Pain: severe (n = 123)
|
8.1 percentage of participants
Interval 4.0 to 14.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 14 days post-dose 3Population: Safety population:participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants whose response was "Yes" for any day or "No" for all days. 'n' = participants whose response was "Yes" for any day or "No" for all days for specified local reaction. Participants may be represented in more than 1 category.
Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm); Moderate (5.5 to 10.0 cm); Severe (\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).
Outcome measures
| Measure |
13vPnC
n=205 Participants
Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
|
|---|---|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Redness: any (n = 105)
|
9.5 percentage of participants
Interval 4.7 to 16.8
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Redness: mild (n = 104)
|
8.7 percentage of participants
Interval 4.0 to 15.8
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Redness: moderate (n = 102)
|
3.9 percentage of participants
Interval 1.1 to 9.7
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Swelling: any (n = 107)
|
11.2 percentage of participants
Interval 5.9 to 18.8
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Swelling: mild (n = 106)
|
8.5 percentage of participants
Interval 4.0 to 15.5
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Swelling: moderate (n = 102)
|
3.9 percentage of participants
Interval 1.1 to 9.7
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Swelling: severe (n = 101)
|
1.0 percentage of participants
Interval 0.0 to 5.4
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Pain: any (n = 204)
|
81.9 percentage of participants
Interval 75.9 to 86.9
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Pain: mild (n = 197)
|
80.2 percentage of participants
Interval 73.9 to 85.5
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Pain: moderate (n = 129)
|
30.2 percentage of participants
Interval 22.5 to 38.9
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Pain: severe (n = 105)
|
5.7 percentage of participants
Interval 2.1 to 12.0
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3
Redness: severe (n = 101)
|
1.0 percentage of participants
Interval 0.0 to 5.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 14 days post-dose 1Population: Safety population:participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants whose response was "Yes" for any day or "No" for all days. 'n' = participants whose response was "Yes" for any day or "No" for all days for specified systemic event. Participants may be represented in more than 1 category.
Specific systemic events (fever greater than or equal to \[\>=\]38 degrees Celsius\[C\], fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours \[hrs\]); Moderate (\>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (\>=6 loose stools in 24 hrs). Report of fever \>40 degrees C after 13vPnC Dose 1 was confirmed as data entry error.
Outcome measures
| Measure |
13vPnC
n=276 Participants
Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
|
|---|---|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Fever >=38 degrees C (n = 162)
|
6.2 percentage of participants
Interval 3.0 to 11.1
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Fever >=38, <38.5 degrees C (n = 160)
|
3.8 percentage of participants
Interval 1.4 to 8.0
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Fever >=38.5, <39 degrees C (n = 157)
|
1.3 percentage of participants
Interval 0.2 to 4.5
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Fever >=39, =<40 degrees C (n = 159)
|
1.3 percentage of participants
Interval 0.2 to 4.5
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Fever >40 degrees C (n = 158)
|
0.6 percentage of participants
Interval 0.0 to 3.5
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Fatigue: any (n = 235)
|
60.0 percentage of participants
Interval 53.4 to 66.3
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Fatigue: mild (n = 223)
|
54.3 percentage of participants
Interval 47.5 to 60.9
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Fatigue: moderate (n = 200)
|
37.5 percentage of participants
Interval 30.8 to 44.6
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Fatigue: severe (n = 163)
|
6.1 percentage of participants
Interval 3.0 to 11.0
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Headache: any (n = 224)
|
61.6 percentage of participants
Interval 54.9 to 68.0
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Headache: mild (n = 216)
|
57.4 percentage of participants
Interval 50.5 to 64.1
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Headache: moderate (n = 183)
|
31.1 percentage of participants
Interval 24.5 to 38.4
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Headache: severe (n = 160)
|
3.1 percentage of participants
Interval 1.0 to 7.1
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Vomiting: any (n = 164)
|
11.6 percentage of participants
Interval 7.1 to 17.5
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Vomiting: mild (n = 164)
|
11.6 percentage of participants
Interval 7.1 to 17.5
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Vomiting: moderate (n = 157)
|
0.0 percentage of participants
Interval 0.0 to 2.3
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Vomiting: severe (n = 157)
|
0.0 percentage of participants
Interval 0.0 to 2.3
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Diarrhea: any (n = 193)
|
44.0 percentage of participants
Interval 36.9 to 51.3
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Diarrhea: mild (n = 191)
|
40.3 percentage of participants
Interval 33.3 to 47.6
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Diarrhea: moderate (n = 166)
|
12.7 percentage of participants
Interval 8.0 to 18.7
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Diarrhea: severe (n = 160)
|
1.9 percentage of participants
Interval 0.4 to 5.4
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
New generalized muscle pain: any (n = 234)
|
65.0 percentage of participants
Interval 58.5 to 71.1
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
New generalized muscle pain: mild (n = 230)
|
60.4 percentage of participants
Interval 53.8 to 66.8
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
New generalized muscle pain: moderate (n = 183)
|
29.5 percentage of participants
Interval 23.0 to 36.7
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
New generalized muscle pain: severe (n = 161)
|
3.7 percentage of participants
Interval 1.4 to 7.9
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
New generalized joint pain: any (n = 193)
|
35.8 percentage of participants
Interval 29.0 to 43.0
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
New generalized joint pain: mild (n = 185)
|
29.7 percentage of participants
Interval 23.2 to 36.9
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
New generalized joint pain: moderate (n = 172)
|
19.2 percentage of participants
Interval 13.6 to 25.9
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
New generalized joint pain: severe (n = 159)
|
1.3 percentage of participants
Interval 0.2 to 4.5
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Use of medication to treat pain (n = 185)
|
29.7 percentage of participants
Interval 23.2 to 36.9
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1
Use of medication to treat fever (n = 173)
|
17.3 percentage of participants
Interval 12.0 to 23.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 14 days post-dose 2Population: Safety population:participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants whose response was "Yes" for any day or "No" for all days. 'n' = participants whose response was "Yes" for any day or "No" for all days for specified systemic event. Participants may be represented in more than 1 category.
Specific systemic events (fever \>=38 degrees C, fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hrs); Moderate (\>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (\>=6 loose stools in 24 hrs).
Outcome measures
| Measure |
13vPnC
n=229 Participants
Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
|
|---|---|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Fever >=38 degrees C (n = 117)
|
5.1 percentage of participants
Interval 1.9 to 10.8
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Fever >=38, <38.5 degrees C (n = 116)
|
4.3 percentage of participants
Interval 1.4 to 9.8
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Fever >=38.5, <39 degrees C (n = 116)
|
0.9 percentage of participants
Interval 0.0 to 4.7
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Fever >=39, =<40 degrees C (n = 115)
|
0.0 percentage of participants
Interval 0.0 to 3.2
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Fever >40 degrees C (n = 115)
|
0.0 percentage of participants
Interval 0.0 to 3.2
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Fatigue: any (n = 188)
|
63.3 percentage of participants
Interval 56.0 to 70.2
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Fatigue: mild (n = 176)
|
57.4 percentage of participants
Interval 49.7 to 64.8
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Fatigue: moderate (n = 154)
|
38.3 percentage of participants
Interval 30.6 to 46.5
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Fatigue: severe (n = 121)
|
7.4 percentage of participants
Interval 3.5 to 13.7
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Headache: any (n = 173)
|
56.1 percentage of participants
Interval 48.3 to 63.6
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Headache: mild (n = 165)
|
48.5 percentage of participants
Interval 40.6 to 56.4
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Headache: moderate (n = 142)
|
31.0 percentage of participants
Interval 23.5 to 39.3
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Headache: severe (n = 117)
|
3.4 percentage of participants
Interval 0.9 to 8.5
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Vomiting: any (n = 120)
|
7.5 percentage of participants
Interval 3.5 to 13.8
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Vomiting: mild (n = 119)
|
6.7 percentage of participants
Interval 2.9 to 12.8
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Vomiting: moderate (n = 116)
|
0.9 percentage of participants
Interval 0.0 to 4.7
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Vomiting: severe (n = 115)
|
0.0 percentage of participants
Interval 0.0 to 3.2
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Diarrhea: any (n = 155)
|
44.5 percentage of participants
Interval 36.5 to 52.7
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Diarrhea: mild (n = 147)
|
39.5 percentage of participants
Interval 31.5 to 47.8
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Diarrhea: moderate (n = 130)
|
15.4 percentage of participants
Interval 9.7 to 22.8
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Diarrhea: severe (n = 119)
|
5.0 percentage of participants
Interval 1.9 to 10.7
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
New generalized muscle pain: any (n = 199)
|
71.9 percentage of participants
Interval 65.1 to 78.0
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
New generalized muscle pain: mild (n = 188)
|
66.0 percentage of participants
Interval 58.7 to 72.7
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
New generalized muscle pain: moderate (n = 153)
|
38.6 percentage of participants
Interval 30.8 to 46.8
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
New generalized muscle pain: severe (n = 125)
|
10.4 percentage of participants
Interval 5.7 to 17.1
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
New generalized joint pain: any (n = 150)
|
40.0 percentage of participants
Interval 32.1 to 48.3
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
New generalized joint pain: mild (n = 144)
|
34.7 percentage of participants
Interval 27.0 to 43.1
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
New generalized joint pain: moderate (n = 135)
|
21.5 percentage of participants
Interval 14.9 to 29.4
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
New generalized joint pain: severe (n = 119)
|
3.4 percentage of participants
Interval 0.9 to 8.4
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Use of medication to treat pain (n = 141)
|
35.5 percentage of participants
Interval 27.6 to 44.0
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2
Use of medication to treat fever (n = 127)
|
18.9 percentage of participants
Interval 12.5 to 26.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 14 days post-dose 3Population: Safety population:participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants whose response was "Yes" for any day or "No" for all days. 'n' = participants whose response was "Yes" for any day or "No" for all days for specified systemic event. Participants may be represented in more than 1 category.
Specific systemic events (fever \>=38 degrees C, fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hrs); Moderate (\>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (\>=6 loose stools in 24 hrs).
Outcome measures
| Measure |
13vPnC
n=203 Participants
Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
|
|---|---|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Fever >=38 degrees C (n = 104)
|
7.7 percentage of participants
Interval 3.4 to 14.6
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Fever >=38, <38.5 degrees C (n = 104)
|
4.8 percentage of participants
Interval 1.6 to 10.9
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Fever >=38.5, <39 degrees C (n = 101)
|
1.0 percentage of participants
Interval 0.0 to 5.4
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Fever >=39, =<40 degrees C (n = 101)
|
2.0 percentage of participants
Interval 0.2 to 7.0
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Fever >40 degrees C (n = 101)
|
0.0 percentage of participants
Interval 0.0 to 3.6
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Fatigue: any (n = 160)
|
56.3 percentage of participants
Interval 48.2 to 64.1
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Fatigue: mild (n = 149)
|
48.3 percentage of participants
Interval 40.1 to 56.6
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Fatigue: moderate (n = 132)
|
36.4 percentage of participants
Interval 28.2 to 45.2
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Fatigue: severe (n = 105)
|
5.7 percentage of participants
Interval 2.1 to 12.0
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Headache: any (n = 137)
|
46.7 percentage of participants
Interval 38.1 to 55.4
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Headache: mild (n = 130)
|
40.8 percentage of participants
Interval 32.2 to 49.7
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Headache: moderate (n = 118)
|
24.6 percentage of participants
Interval 17.1 to 33.4
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Headache: severe (n = 103)
|
4.9 percentage of participants
Interval 1.6 to 11.0
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Vomiting: any (n = 109)
|
11.0 percentage of participants
Interval 5.8 to 18.4
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Vomiting: mild (n = 107)
|
8.4 percentage of participants
Interval 3.9 to 15.4
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Vomiting: moderate (n = 104)
|
4.8 percentage of participants
Interval 1.6 to 10.9
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Vomiting: severe (n = 101)
|
0.0 percentage of participants
Interval 0.0 to 3.6
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Diarrhea: any (n = 134)
|
38.8 percentage of participants
Interval 30.5 to 47.6
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Diarrhea: mild (n = 131)
|
35.9 percentage of participants
Interval 27.7 to 44.7
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Diarrhea: moderate (n = 109)
|
11.9 percentage of participants
Interval 6.5 to 19.5
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Diarrhea: severe (n = 103)
|
1.9 percentage of participants
Interval 0.2 to 6.8
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
New generalized muscle pain: any (n = 170)
|
65.9 percentage of participants
Interval 58.2 to 73.0
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
New generalized muscle pain: mild (n = 155)
|
61.3 percentage of participants
Interval 53.1 to 69.0
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
New generalized muscle pain: moderate (n = 132)
|
31.1 percentage of participants
Interval 23.3 to 39.7
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
New generalized muscle pain: severe (n = 110)
|
10.0 percentage of participants
Interval 5.1 to 17.2
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
New generalized joint pain: any (n = 129)
|
31.8 percentage of participants
Interval 23.9 to 40.6
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
New generalized joint pain: mild (n = 119)
|
26.1 percentage of participants
Interval 18.4 to 34.9
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
New generalized joint pain: moderate (n = 120)
|
20.0 percentage of participants
Interval 13.3 to 28.3
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
New generalized joint pain: severe (n = 106)
|
5.7 percentage of participants
Interval 2.1 to 11.9
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Use of medication to treat pain (n = 122)
|
32.0 percentage of participants
Interval 23.8 to 41.0
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3
Use of medication to treat fever (n = 118)
|
25.4 percentage of participants
Interval 17.9 to 34.3
|
Adverse Events
13vPnC (After Dose 1 and Before Dose 2)
Serious events: 24 serious events
Other events: 244 other events
Deaths: 0 deaths
13vPnC (After Dose 2 and Before Dose 3)
Serious events: 14 serious events
Other events: 196 other events
Deaths: 0 deaths
13vPnC (After Dose 3 and Before Dose 3 Blood Draw)
Serious events: 4 serious events
Other events: 169 other events
Deaths: 0 deaths
13vPnC (After Dose 3 Blood Draw)
Serious events: 10 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
13vPnC (After Dose 1 and Before Dose 2)
n=329 participants at risk
Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received 1 dose of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and were assessed from 13vPnC Dose 1 to prior to administration of 13vPnC Dose 2.
|
13vPnC (After Dose 2 and Before Dose 3)
n=300 participants at risk
Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received 2 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 6 months apart and were assessed from 13vPnC Dose 2 prior to administration of 13vPnC Dose 3.
|
13vPnC (After Dose 3 and Before Dose 3 Blood Draw)
n=278 participants at risk
Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 6 months apart and were assessed from 13vPnC Dose 3 to prior to the blood draw 28 to 42 days post-13vPnC Dose 3.
|
13vPnC (After Dose 3 Blood Draw)
n=329 participants at risk
Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received at least 1 of the 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 6 months apart and were assessed from the blood draw 28 to 42 days post-13vPnC Dose 3 up to 6-month follow-up.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Cardiac disorders
Coronary artery disease
|
0.91%
3/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Cardiac disorders
Myocardial infarction
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.67%
2/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Non-cardiac chest pain
|
0.61%
2/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Oedema peripheral
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Chest discomfort
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Bronchitis viral
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Mediastinal abscess
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Mycobacterium abscessus infection
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Cytomegalovirus hepatitis
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.61%
2/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ of penis
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma of the skin
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Nervous system disorders
Complicated migraine
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Nervous system disorders
Convulsion
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Nervous system disorders
Headache
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Psychiatric disorders
Depression
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Psychiatric disorders
Substance abuse
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Psychiatric disorders
Alcohol abuse
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Renal and urinary disorders
Bladder prolapse
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Vascular disorders
Deep vein thrombosis
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Vascular disorders
Aortic aneurysm
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
Other adverse events
| Measure |
13vPnC (After Dose 1 and Before Dose 2)
n=329 participants at risk
Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received 1 dose of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and were assessed from 13vPnC Dose 1 to prior to administration of 13vPnC Dose 2.
|
13vPnC (After Dose 2 and Before Dose 3)
n=300 participants at risk
Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received 2 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 6 months apart and were assessed from 13vPnC Dose 2 prior to administration of 13vPnC Dose 3.
|
13vPnC (After Dose 3 and Before Dose 3 Blood Draw)
n=278 participants at risk
Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 6 months apart and were assessed from 13vPnC Dose 3 to prior to the blood draw 28 to 42 days post-13vPnC Dose 3.
|
13vPnC (After Dose 3 Blood Draw)
n=329 participants at risk
Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received at least 1 of the 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 6 months apart and were assessed from the blood draw 28 to 42 days post-13vPnC Dose 3 up to 6-month follow-up.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.91%
3/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Cardiac disorders
Atrial fibrillation
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Cardiac disorders
Palpitations
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.67%
2/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
1.1%
3/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Ear and labyrinth disorders
Eustachian tube disorder
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Eye disorders
Eye irritation
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Eye disorders
Vision blurred
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Eye disorders
Episcleritis
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Eye disorders
Iritis
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
5/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
1.3%
4/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Nausea
|
0.91%
3/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.72%
2/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.91%
3/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Oral pain
|
0.61%
2/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Anal fissure
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Constipation
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
1.3%
4/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Flatulence
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Tongue haemorrhage
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Toothache
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Vomiting
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.67%
2/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Anogenital dysplasia
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Pyrexia
|
1.8%
6/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.72%
2/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Fatigue
|
1.2%
4/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
2.7%
8/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Influenza like illness
|
0.61%
2/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Asthenia
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Chest pain
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Injection site pain
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Injection site paraesthesia
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Oedema
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Oedema peripheral
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Pain
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.67%
2/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Malaise
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Chills
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Immune system disorders
Seasonal allergy
|
0.61%
2/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.67%
2/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.72%
2/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Immune system disorders
Food allergy
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.2%
17/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
2.7%
8/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Folliculitis
|
1.5%
5/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Bronchitis
|
1.2%
4/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.67%
2/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
1.4%
4/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Laryngitis
|
0.91%
3/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Sinusitis
|
0.91%
3/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
1.1%
3/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Body tinea
|
0.61%
2/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Herpes zoster
|
0.61%
2/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Pharyngitis
|
0.61%
2/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.72%
2/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Syphilis
|
0.61%
2/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Bronchitis viral
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Cellulitis
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Hepatitis C
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Herpes simplex
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Influenza
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Nasopharyngitis
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Orchitis
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Paronychia
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Urethritis
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Viral diarrhoea
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
1.0%
3/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.67%
2/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.67%
2/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Balanitis candida
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Ear infection
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.61%
2/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Giardiasis
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Gonorrhoea
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Post viral fatigue syndrome
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.72%
2/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Abscess
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Keratitis herpetic
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Furuncle
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.61%
2/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Investigations
Anal pap smear abnormal
|
0.61%
2/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Investigations
Prostatic specific antigen increased
|
0.61%
2/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Investigations
Weight increased
|
0.61%
2/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Investigations
Blood pressure increased
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Investigations
CD4 lymphocytes decreased
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Investigations
Electrocardiogram PR prolongation
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Investigations
Liver function test abnormal
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Investigations
Viral load increased
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Investigations
Weight decreased
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Investigations
Alanine aminotransferase increased
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Investigations
Aspartate aminotransferase increased
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Investigations
Blood testosterone decreased
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Investigations
Transaminases increased
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Investigations
Tuberculin test positive
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.61%
2/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.61%
2/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.67%
2/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.61%
2/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.61%
2/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
4/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
1.3%
4/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.91%
3/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.2%
4/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.91%
3/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.61%
2/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
1.3%
4/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Musculoskeletal and connective tissue disorders
Muscle disorder
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Musculoskeletal and connective tissue disorders
Myalgia intercostal
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Musculoskeletal and connective tissue disorders
Femoroacetabular impingement
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral neoplasm
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervicitis human papilloma virus
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Nervous system disorders
Headache
|
2.7%
9/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Nervous system disorders
Sinus headache
|
0.61%
2/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Nervous system disorders
Dizziness
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Nervous system disorders
Dysgeusia
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Nervous system disorders
Hypoaesthesia
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.67%
2/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Nervous system disorders
Migraine
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.67%
2/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Nervous system disorders
Paraesthesia
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.61%
2/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Nervous system disorders
Syncope
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Nervous system disorders
Tremor
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.61%
2/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Psychiatric disorders
Depression
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.67%
2/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Psychiatric disorders
Anxiety
|
0.61%
2/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.67%
2/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Psychiatric disorders
Sleep disorder
|
0.61%
2/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Psychiatric disorders
Bipolar disorder
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Psychiatric disorders
Fear
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Psychiatric disorders
Insomnia
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Psychiatric disorders
Panic attack
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Psychiatric disorders
Substance abuse
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Psychiatric disorders
Tobacco abuse
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Renal and urinary disorders
Renal failure acute
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Reproductive system and breast disorders
Genital pain
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Reproductive system and breast disorders
Genital rash
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Reproductive system and breast disorders
Uterine cervical squamous metaplasia
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Reproductive system and breast disorders
Vulvar dysplasia
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.8%
6/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
1.1%
3/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.91%
3/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.67%
2/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.91%
3/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.61%
2/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
1.0%
3/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.61%
2/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
1.0%
3/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.1%
7/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
1.3%
4/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.61%
2/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Skin and subcutaneous tissue disorders
Idiopathic urticaria
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Vascular disorders
Hypertension
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.67%
2/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Fever (>=38 degrees C)
|
6.2%
10/162 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
5.1%
6/117 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
7.7%
8/104 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Vascular disorders
Flushing
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Vascular disorders
Hot flush
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.30%
1/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Skin and subcutaneous tissue disorders
Redness (Any)
|
5.6%
9/162 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
8.2%
10/122 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
9.5%
10/105 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Skin and subcutaneous tissue disorders
Redness (Mild)
|
4.3%
7/161 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
6.7%
8/120 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
8.7%
9/104 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Skin and subcutaneous tissue disorders
Redness (Moderate)
|
1.3%
2/158 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
1.7%
2/117 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
3.9%
4/102 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Skin and subcutaneous tissue disorders
Redness (Severe)
|
0.00%
0/157 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
1.7%
2/117 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.99%
1/101 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Skin and subcutaneous tissue disorders
Swelling (Any)
|
6.8%
11/162 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
12.7%
16/126 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
11.2%
12/107 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Skin and subcutaneous tissue disorders
Swelling (Mild)
|
6.2%
10/161 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
12.0%
15/125 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
8.5%
9/106 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Skin and subcutaneous tissue disorders
Swelling (Moderate)
|
0.63%
1/158 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.86%
1/116 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
3.9%
4/102 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Skin and subcutaneous tissue disorders
Swelling (Severe)
|
0.63%
1/158 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
1.7%
2/117 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.99%
1/101 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Skin and subcutaneous tissue disorders
Pain (Any)
|
78.8%
205/260 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
81.4%
193/237 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
81.9%
167/204 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Skin and subcutaneous tissue disorders
Pain (Mild)
|
76.4%
197/258 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
78.7%
181/230 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
80.2%
158/197 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Skin and subcutaneous tissue disorders
Pain (Moderate)
|
18.5%
32/173 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
33.3%
50/150 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
30.2%
39/129 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Skin and subcutaneous tissue disorders
Pain (Severe)
|
1.3%
2/158 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
8.1%
10/123 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
5.7%
6/105 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Fever (>=38 but <38.5 degrees C)
|
3.8%
6/160 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
4.3%
5/116 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
4.8%
5/104 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Fever (>=38.5 but <39 degrees C)
|
1.3%
2/157 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.86%
1/116 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.99%
1/101 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Fever (>=39 but =<40 degrees C)
|
1.3%
2/159 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/115 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
2.0%
2/101 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Fever (>40 degrees C)
|
0.63%
1/158 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/115 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/101 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Fatigue (Any)
|
60.0%
141/235 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
63.3%
119/188 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
56.2%
90/160 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Fatigue (Mild)
|
54.3%
121/223 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
57.4%
101/176 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
48.3%
72/149 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Fatigue (Moderate)
|
37.5%
75/200 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
38.3%
59/154 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
36.4%
48/132 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Fatigue (Severe)
|
6.1%
10/163 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
7.4%
9/121 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
5.7%
6/105 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Headache (Any)
|
61.6%
138/224 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
56.1%
97/173 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
46.7%
64/137 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Headache (Mild)
|
57.4%
124/216 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
48.5%
80/165 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
40.8%
53/130 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Headache (Moderate)
|
31.1%
57/183 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
31.0%
44/142 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
24.6%
29/118 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Headache (Severe)
|
3.1%
5/160 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
3.4%
4/117 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
4.9%
5/103 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Vomiting (Any)
|
11.6%
19/164 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
7.5%
9/120 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
11.0%
12/109 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Vomiting (Mild)
|
11.6%
19/164 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
6.7%
8/119 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
8.4%
9/107 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Vomiting (Moderate)
|
0.00%
0/157 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.86%
1/116 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
4.8%
5/104 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Vomiting (Severe)
|
0.00%
0/157 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/115 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/101 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Diarrhea (Any)
|
44.0%
85/193 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
44.5%
69/155 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
38.8%
52/134 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Diarrhea (Mild)
|
40.3%
77/191 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
39.5%
58/147 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
35.9%
47/131 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Diarrhea (Moderate)
|
12.7%
21/166 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
15.4%
20/130 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
11.9%
13/109 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
Diarrhea (Severe)
|
1.9%
3/160 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
5.0%
6/119 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
1.9%
2/103 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
New generalized muscle pain (Any)
|
65.0%
152/234 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
71.9%
143/199 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
65.9%
112/170 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
New generalized muscle pain (Mild)
|
60.4%
139/230 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
66.0%
124/188 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
61.3%
95/155 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
New generalized muscle pain (Moderate)
|
29.5%
54/183 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
38.6%
59/153 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
31.1%
41/132 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
New generalized muscle pain (Severe)
|
3.7%
6/161 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
10.4%
13/125 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
10.0%
11/110 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
New generalized joint pain (Any)
|
35.8%
69/193 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
40.0%
60/150 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
31.8%
41/129 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
New generalized joint pain (Mild)
|
29.7%
55/185 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
34.7%
50/144 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
26.1%
31/119 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
New generalized joint pain (Moderate)
|
19.2%
33/172 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
21.5%
29/135 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
20.0%
24/120 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
General disorders
New generalized joint pain (Severe)
|
1.3%
2/159 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
3.4%
4/119 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
5.7%
6/106 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Social circumstances
Bereavement
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.33%
1/300 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.36%
1/278 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
0.00%
0/329 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events (up to 14 days after each vaccine dose)
SAEs, AEs were grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local and systemic reactions;systematic assessment), events collected on case report form at each visit (nonsystematic assessment). 1 Participant received Dose 3 but had no safety data available;hence 278 evaluable in after Dose 3 group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER