Trial Outcomes & Findings for 13vPnC Multidose Vial Safety, Tolerability and Immunogenicity Study in Healthy Infants. (NCT NCT01964716)
NCT ID: NCT01964716
Last Updated: 2015-03-13
Results Overview
Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here "n"= participants with valid and determinate IgG concentration to the given serotype.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
500 participants
Primary outcome timeframe
1 month after the infant series
Results posted on
2015-03-13
Participant Flow
Total number of participants screened were 526, out of which 500 were enrolled in the study. The study was conducted in Gambia which started on 09 January 2014 and completed on 01 September 2014.
Participant milestones
| Measure |
13vPnC Multi-dose Vial (MDV)
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
|
13vPnC Single-Dose Syringe (SDS)
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
|
|---|---|---|
|
Overall Study
STARTED
|
250
|
250
|
|
Overall Study
Vaccinated Dose 1
|
250
|
250
|
|
Overall Study
Vaccinated Dose 2
|
249
|
248
|
|
Overall Study
Vaccinated Dose 3
|
247
|
244
|
|
Overall Study
COMPLETED
|
245
|
244
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
13vPnC Multi-dose Vial (MDV)
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
|
13vPnC Single-Dose Syringe (SDS)
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
No longer met eligibility criteria
|
1
|
1
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
13vPnC Multidose Vial Safety, Tolerability and Immunogenicity Study in Healthy Infants.
Baseline characteristics by cohort
| Measure |
13vPnC Multi-dose Vial (MDV)
n=250 Participants
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
|
13vPnC Single-Dose Syringe (SDS)
n=250 Participants
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
|
Total
n=500 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.3 days
STANDARD_DEVIATION 8.6 • n=5 Participants
|
56.9 days
STANDARD_DEVIATION 8.8 • n=7 Participants
|
57.1 days
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
129 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
259 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
121 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
241 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 month after the infant seriesPopulation: Evaluable immunogenicity population: eligible participants who received vaccine (as randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations.
Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here "n"= participants with valid and determinate IgG concentration to the given serotype.
Outcome measures
| Measure |
13vPnC Multi-dose Vial (MDV)
n=245 Participants
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
|
13vPnC Single-Dose Syringe (SDS)
n=244 Participants
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
|
Screened Only
Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization.
|
|---|---|---|---|
|
Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group
Serotype 18C (n=245,244)
|
99.2 percentage of participants
Interval 97.1 to 99.9
|
98.0 percentage of participants
Interval 95.3 to 99.3
|
—
|
|
Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group
Serotype 1 (n=245,244)
|
99.2 percentage of participants
Interval 97.1 to 99.9
|
100.0 percentage of participants
Interval 98.5 to 100.0
|
—
|
|
Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group
Serotype 3 (n=245,243)
|
98.8 percentage of participants
Interval 96.5 to 99.7
|
99.6 percentage of participants
Interval 97.7 to 100.0
|
—
|
|
Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group
Serotype 4 (n=245,244)
|
99.6 percentage of participants
Interval 97.7 to 100.0
|
99.6 percentage of participants
Interval 97.7 to 100.0
|
—
|
|
Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group
Serotype 5 (n=245,244)
|
95.9 percentage of participants
Interval 92.6 to 98.0
|
97.1 percentage of participants
Interval 94.2 to 98.8
|
—
|
|
Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group
Serotype 6A (n=243,244)
|
96.3 percentage of participants
Interval 93.1 to 98.3
|
97.5 percentage of participants
Interval 94.7 to 99.1
|
—
|
|
Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group
Serotype 6B (n=245,244)
|
95.1 percentage of participants
Interval 91.6 to 97.4
|
95.1 percentage of participants
Interval 91.6 to 97.4
|
—
|
|
Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group
Serotype 7F (n=245,244)
|
99.6 percentage of participants
Interval 97.7 to 100.0
|
100.0 percentage of participants
Interval 98.5 to 100.0
|
—
|
|
Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group
Serotype 9V (n=245,244)
|
98.0 percentage of participants
Interval 95.3 to 99.3
|
98.4 percentage of participants
Interval 95.9 to 99.6
|
—
|
|
Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group
Serotype 14 (n=245,244)
|
97.6 percentage of participants
Interval 94.7 to 99.1
|
98.4 percentage of participants
Interval 95.9 to 99.6
|
—
|
|
Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group
Serotype 19A (n=245,244)
|
99.6 percentage of participants
Interval 97.7 to 100.0
|
98.8 percentage of participants
Interval 96.4 to 99.7
|
—
|
|
Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group
Serotype 19F (n=245,244)
|
96.7 percentage of participants
Interval 93.7 to 98.6
|
97.1 percentage of participants
Interval 94.2 to 98.8
|
—
|
|
Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group
Serotype 23F (n=245,244)
|
95.9 percentage of participants
Interval 92.6 to 98.0
|
95.9 percentage of participants
Interval 92.6 to 98.0
|
—
|
PRIMARY outcome
Timeframe: 1 month after the infant seriesPopulation: Evaluable immunogenicity population: eligible participants who received vaccine (as randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations.
Antibody GMC for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations. Here "n"= participants with valid and determinate IgG concentration to the given serotype.
Outcome measures
| Measure |
13vPnC Multi-dose Vial (MDV)
n=245 Participants
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
|
13vPnC Single-Dose Syringe (SDS)
n=244 Participants
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
|
Screened Only
Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization.
|
|---|---|---|---|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group
Serotype 1 (n=245,244)
|
4.59 microgram per milliliter (mcg/mL)
Interval 4.11 to 5.12
|
4.45 microgram per milliliter (mcg/mL)
Interval 4.01 to 4.93
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group
Serotype 5 (n=245,244)
|
2.00 microgram per milliliter (mcg/mL)
Interval 1.79 to 2.22
|
1.98 microgram per milliliter (mcg/mL)
Interval 1.79 to 2.2
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group
Serotype 3 (n=245,243)
|
1.38 microgram per milliliter (mcg/mL)
Interval 1.29 to 1.49
|
1.74 microgram per milliliter (mcg/mL)
Interval 1.62 to 1.87
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group
Serotype 4 (n=245,244)
|
5.30 microgram per milliliter (mcg/mL)
Interval 4.84 to 5.81
|
5.28 microgram per milliliter (mcg/mL)
Interval 4.76 to 5.85
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group
Serotype 6A (n=243,244)
|
2.25 microgram per milliliter (mcg/mL)
Interval 2.02 to 2.5
|
2.19 microgram per milliliter (mcg/mL)
Interval 1.96 to 2.44
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group
Serotype 6B (n=245,244)
|
3.42 microgram per milliliter (mcg/mL)
Interval 2.91 to 4.02
|
3.24 microgram per milliliter (mcg/mL)
Interval 2.77 to 3.78
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group
Serotype 7F (n=245,244)
|
3.92 microgram per milliliter (mcg/mL)
Interval 3.59 to 4.27
|
4.18 microgram per milliliter (mcg/mL)
Interval 3.83 to 4.55
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group
Serotype 9V (n=245,244)
|
2.83 microgram per milliliter (mcg/mL)
Interval 2.56 to 3.13
|
2.75 microgram per milliliter (mcg/mL)
Interval 2.49 to 3.04
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group
Serotype 14 (n=245,244)
|
4.78 microgram per milliliter (mcg/mL)
Interval 4.06 to 5.63
|
4.96 microgram per milliliter (mcg/mL)
Interval 4.27 to 5.77
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group
Serotype 18C (n=245,244)
|
3.47 microgram per milliliter (mcg/mL)
Interval 3.17 to 3.79
|
2.72 microgram per milliliter (mcg/mL)
Interval 2.46 to 3.0
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group
Serotype 19A (n=245,244)
|
6.49 microgram per milliliter (mcg/mL)
Interval 5.7 to 7.38
|
6.44 microgram per milliliter (mcg/mL)
Interval 5.66 to 7.32
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group
Serotype 19F (n=245,244)
|
5.19 microgram per milliliter (mcg/mL)
Interval 4.59 to 5.86
|
5.00 microgram per milliliter (mcg/mL)
Interval 4.43 to 5.63
|
—
|
|
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group
Serotype 23F (n=245,244)
|
2.61 microgram per milliliter (mcg/mL)
Interval 2.3 to 2.97
|
2.17 microgram per milliliter (mcg/mL)
Interval 1.92 to 2.46
|
—
|
PRIMARY outcome
Timeframe: Within 5 days after Dose 1(Day 2 to Day 6) of the infant seriesPopulation: Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was "Yes" for any day or "No" for all days.
Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than \[\>\] 7.0 cm). Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC Multi-dose Vial (MDV)
n=248 Participants
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
|
13vPnC Single-Dose Syringe (SDS)
n=250 Participants
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
|
Screened Only
Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization.
|
|---|---|---|---|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group
Redness: Severe
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group
Tenderness: Mild
|
32 participants
|
37 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group
Tenderness: Moderate
|
13 participants
|
14 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group
Redness: Any
|
1 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group
Redness: Mild
|
1 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group
Redness: Moderate
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group
Swelling: Any
|
1 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group
Swelling: Mild
|
1 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group
Swelling: Moderate
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group
Swelling: Severe
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group
Tenderness: Any
|
42 participants
|
47 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group
Tenderness: Severe
|
0 participants
|
0 participants
|
—
|
PRIMARY outcome
Timeframe: Within 5 days after Dose 2 (Day 2 to Day 6) of the infant seriesPopulation: Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was "Yes" for any day or "No" for all days and 'n' = participants whose response was "Yes" for any day or "No" for all days for specified local reaction.
Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than \[\>\] 7.0 cm). Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC Multi-dose Vial (MDV)
n=248 Participants
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
|
13vPnC Single-Dose Syringe (SDS)
n=247 Participants
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
|
Screened Only
Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization.
|
|---|---|---|---|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group
Redness: Moderate (n=247, 247)
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group
Redness: Any (n=247, 247)
|
2 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group
Redness: Mild (n=247, 247)
|
2 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group
Redness: Severe (n=247, 247)
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group
Swelling: Any (n=247, 247)
|
2 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group
Swelling: Mild (n=247, 247)
|
2 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group
Swelling: Moderate (n=247, 247)
|
1 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group
Swelling: Severe (n=247, 247)
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group
Tenderness: Any (n=248, 247)
|
34 participants
|
32 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group
Tenderness: Mild (n=248, 247)
|
27 participants
|
28 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group
Tenderness: Moderate (n=247, 247)
|
7 participants
|
5 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group
Tenderness: Severe (n=247, 247)
|
0 participants
|
0 participants
|
—
|
PRIMARY outcome
Timeframe: Within 5 days after Dose 3 (Day 2 to Day 6) of the infant seriesPopulation: Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was "Yes" for any day or "No" for all days.
Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than \[\>\] 7.0 cm). Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC Multi-dose Vial (MDV)
n=246 Participants
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
|
13vPnC Single-Dose Syringe (SDS)
n=241 Participants
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
|
Screened Only
Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization.
|
|---|---|---|---|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group
Redness: Any
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group
Redness: Mild
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group
Redness: Moderate
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group
Redness: Severe
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group
Swelling: Any
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group
Swelling: Mild
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group
Swelling: Moderate
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group
Swelling: Severe
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group
Tenderness: Any
|
37 participants
|
35 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group
Tenderness: Mild
|
30 participants
|
32 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group
Tenderness: Moderate
|
9 participants
|
4 participants
|
—
|
|
Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group
Tenderness: Severe
|
0 participants
|
0 participants
|
—
|
PRIMARY outcome
Timeframe: Within 5 days after Dose 1 (Day 2 to Day 6) of infant seriesPopulation: Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was "Yes" for any day or "No" for all days. 'n' included participants whose response was "Yes" for any day or "No" for all days for specified systemic event.
Systemic events (any fever greater than or equal to \[\>=\] 38.0 degrees Celsius \[C\], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC Multi-dose Vial (MDV)
n=249 Participants
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
|
13vPnC Single-Dose Syringe (SDS)
n=250 Participants
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
|
Screened Only
Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization.
|
|---|---|---|---|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group
Increased sleep: Any (n=248, 250)
|
16 participants
|
14 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group
Increased sleep: Mild (n=248, 250)
|
11 participants
|
10 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group
Fever: >=38.0 degree C (n=248, 250)
|
9 participants
|
7 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group
Fever: >=38.0 but <=39.0 degrees C (n=248, 250)
|
9 participants
|
7 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group
Fever: >39.0 but <=40.0 degrees C (n=248, 250)
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group
Fever: >40.0 degrees C (n=248, 250)
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group
Decreased appetite: Any (n=248, 250)
|
17 participants
|
26 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group
Decreased appetite: Moderate (n=248, 250)
|
17 participants
|
26 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group
Decreased appetite: Severe (n=248, 250)
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group
Irritability: Any (n=249, 250)
|
103 participants
|
93 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group
Irritability: Mild (n=249, 250)
|
86 participants
|
77 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group
Irritability: Moderate (n=248, 250)
|
19 participants
|
17 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group
Irritability: Severe (n=248, 250)
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group
Increased sleep: Moderate (n=248, 250)
|
6 participants
|
4 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group
Increased sleep: Severe (n=248, 250)
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group
Use of antipyretic medication (n=248, 250)
|
55 participants
|
58 participants
|
—
|
PRIMARY outcome
Timeframe: Within 5 days after Dose 2 (Day 2 to Day 6) of infant seriesPopulation: Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was "Yes" for any day or "No" for all days. 'n' included participants whose response was "Yes" for any day or "No" for all days for specified systemic event.
Systemic events (any fever greater than or equal to \[\>=\] 38.0 degrees Celsius \[C\], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC Multi-dose Vial (MDV)
n=248 Participants
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
|
13vPnC Single-Dose Syringe (SDS)
n=247 Participants
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
|
Screened Only
Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization.
|
|---|---|---|---|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group
Decreased appetite: Moderate (n=247, 247)
|
28 participants
|
18 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group
Fever: >=38.0 degree C (n=247, 247)
|
7 participants
|
7 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group
Fever: >=38.0 but <=39.0 degrees C (n=247, 247)
|
7 participants
|
7 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group
Fever: >39.0 but <=40.0 degrees C (n=247, 247)
|
1 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group
Fever: >40.0 degrees C (n=247, 247)
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group
Decreased appetite: Any(n=247, 247)
|
28 participants
|
18 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group
Decreased appetite: Severe (n=247, 247)
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group
Irritability: Any (n=248, 247)
|
93 participants
|
83 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group
Irritability: Mild (n=248, 247)
|
75 participants
|
67 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group
Irritability: Moderate (n=247, 247)
|
23 participants
|
17 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group
Irritability: Severe (n=247, 247)
|
0 participants
|
3 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group
Increased sleep: Any (n=247, 247)
|
24 participants
|
14 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group
Increased sleep: Mild (n=247, 247)
|
20 participants
|
12 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group
Increased sleep: Moderate (n=247, 247)
|
4 participants
|
1 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group
Increased sleep: Severe (n=247, 247)
|
0 participants
|
1 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group
Use of antipyretic medication (n=248, 247)
|
46 participants
|
43 participants
|
—
|
PRIMARY outcome
Timeframe: Within 5 days after Dose 3 (Day 2 to Day 6) of infant seriesPopulation: Safety population included participants who received at least 1 dose of study vaccine. 'N' (number of participants analyzed) included participants whose response was "Yes" for any day or "No" for all days. 'n' included participants whose response was "Yes" for any day or "No" for all days for specified systemic event.
Systemic events (any fever greater than or equal to \[\>=\] 38.0 degrees Celsius \[C\], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC Multi-dose Vial (MDV)
n=246 Participants
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
|
13vPnC Single-Dose Syringe (SDS)
n=243 Participants
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
|
Screened Only
Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization.
|
|---|---|---|---|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group
Fever: >=38.0 degree C (n=246, 241)
|
3 participants
|
8 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group
Increased sleep: Mild (n=246, 241)
|
10 participants
|
11 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group
Increased sleep: Moderate (n=246, 241)
|
2 participants
|
1 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group
Fever: >=38.0 but <=39.0 degrees C (n=246, 241)
|
3 participants
|
7 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group
Fever: >39.0 but <=40.0 degrees C (n=246, 241)
|
0 participants
|
1 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group
Fever: >40.0 degrees C (n=246, 241)
|
0 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group
Decreased appetite: Any (n=246, 242)
|
24 participants
|
20 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group
Decreased appetite: Moderate (n=246, 242)
|
24 participants
|
19 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group
Decreased appetite: Severe (n=246, 241)
|
0 participants
|
1 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group
Irritability: Any (n=246, 243)
|
83 participants
|
92 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group
Irritability: Mild (n=246, 242)
|
71 participants
|
74 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group
Irritability: Moderate (n=246, 242)
|
15 participants
|
18 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group
Irritability: Severe (n=246, 241)
|
1 participants
|
5 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group
Increased sleep: Any (n=246, 241)
|
12 participants
|
12 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group
Increased sleep: Severe (n=246, 241)
|
1 participants
|
0 participants
|
—
|
|
Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group
Use of antipyretic medication (n=246, 241)
|
34 participants
|
36 participants
|
—
|
PRIMARY outcome
Timeframe: Dose 1 up to 28 to 42 days after dose 3Population: Safety population included all participants who received at least 1 dose of study vaccine.
An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 to 42 days after last dose that were absent before treatment or that worsened relative to pretreatment state
Outcome measures
| Measure |
13vPnC Multi-dose Vial (MDV)
n=250 Participants
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
|
13vPnC Single-Dose Syringe (SDS)
n=250 Participants
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
|
Screened Only
Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Infant Series
AEs
|
123 participants
|
127 participants
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Infant Series
SAEs
|
1 participants
|
0 participants
|
—
|
PRIMARY outcome
Timeframe: Informed consent up to Dose 1Population: Safety population: participants who received at least 1 dose of study vaccine. Here "N"= participants evaluable for this outcome measure.
An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse events were also reported in participants who provided consent but were not randomized in this study. The data of these participants has been reported under 'Screened Only' arm.
Outcome measures
| Measure |
13vPnC Multi-dose Vial (MDV)
n=250 Participants
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
|
13vPnC Single-Dose Syringe (SDS)
n=250 Participants
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
|
Screened Only
n=26 Participants
Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1
AEs
|
2 participants
|
0 participants
|
9 participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1
SAEs
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 1 month after the infant seriesPopulation: Evaluable immunogenicity population:participants who received vaccine (randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations. OPA analysis was performed in a subset of randomly selected participants from each group.
Percentage of participants achieving OPA Titer \>= lower limit of quantitation (LLOQ) along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here "n"= Number of participants with an antibody titer ≥ LLOQ for the given serotype.
Outcome measures
| Measure |
13vPnC Multi-dose Vial (MDV)
n=160 Participants
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
|
13vPnC Single-Dose Syringe (SDS)
n=160 Participants
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
|
Screened Only
Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization.
|
|---|---|---|---|
|
Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
Serotype 4 (n=159,159)
|
100.0 percentage of participants
Interval 97.7 to 100.0
|
100.0 percentage of participants
Interval 97.7 to 100.0
|
—
|
|
Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
Serotype 23F (n=159,160)
|
96.2 percentage of participants
Interval 92.0 to 98.6
|
97.5 percentage of participants
Interval 93.7 to 99.3
|
—
|
|
Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
Serotype 18C (n=159,160)
|
99.4 percentage of participants
Interval 96.5 to 100.0
|
99.4 percentage of participants
Interval 96.6 to 100.0
|
—
|
|
Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
Serotype 19A (n=160,160)
|
95.6 percentage of participants
Interval 91.2 to 98.2
|
97.5 percentage of participants
Interval 93.7 to 99.3
|
—
|
|
Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
Serotype 19F (n=158,159)
|
93.7 percentage of participants
Interval 88.7 to 96.9
|
94.3 percentage of participants
Interval 89.5 to 97.4
|
—
|
|
Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
Serotype 1 (n=159,160)
|
71.7 percentage of participants
Interval 64.0 to 78.5
|
79.4 percentage of participants
Interval 72.3 to 85.4
|
—
|
|
Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
Serotype 3 (n=160,160)
|
98.8 percentage of participants
Interval 95.6 to 99.8
|
100.0 percentage of participants
Interval 97.7 to 100.0
|
—
|
|
Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
Serotype 5 (n=160,159)
|
83.1 percentage of participants
Interval 76.4 to 88.6
|
85.5 percentage of participants
Interval 79.1 to 90.6
|
—
|
|
Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
Serotype 6A (n=160,160)
|
99.4 percentage of participants
Interval 96.6 to 100.0
|
99.4 percentage of participants
Interval 96.6 to 100.0
|
—
|
|
Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
Serotype 6B (n=156,155)
|
96.8 percentage of participants
Interval 92.7 to 99.0
|
96.8 percentage of participants
Interval 92.6 to 98.9
|
—
|
|
Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
Serotype 7F (n=159,160)
|
100.0 percentage of participants
Interval 97.7 to 100.0
|
100.0 percentage of participants
Interval 97.7 to 100.0
|
—
|
|
Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
Serotype 9V (n=158,160)
|
79.7 percentage of participants
Interval 72.6 to 85.7
|
75.0 percentage of participants
Interval 67.6 to 81.5
|
—
|
|
Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series
Serotype 14 (n=157,160)
|
81.5 percentage of participants
Interval 74.6 to 87.3
|
89.4 percentage of participants
Interval 83.5 to 93.7
|
—
|
SECONDARY outcome
Timeframe: 1 month after the infant seriesPopulation: Evaluable immunogenicity population:participants who received vaccine (randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations. OPA analysis was performed in a subset of randomly selected participants from each group.
Antibody geometric mean titers as measured by OPA assay for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMTs were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. Here "n"= participants evaluable =specified category.
Outcome measures
| Measure |
13vPnC Multi-dose Vial (MDV)
n=160 Participants
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
|
13vPnC Single-Dose Syringe (SDS)
n=160 Participants
Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
|
Screened Only
Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization.
|
|---|---|---|---|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series
Serotype 1 (n=159,160)
|
48 titer
Interval 39.0 to 58.0
|
52 titer
Interval 43.2 to 62.6
|
—
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series
Serotype 3 (n=160,160)
|
97 titer
Interval 87.3 to 108.8
|
122 titer
Interval 110.1 to 135.7
|
—
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series
Serotype 4 (n=159,159)
|
1666 titer
Interval 1412.3 to 1966.3
|
1492 titer
Interval 1285.2 to 1732.3
|
—
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series
Serotype 5 (n=160,159)
|
79 titer
Interval 67.7 to 92.4
|
80 titer
Interval 69.1 to 92.6
|
—
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series
Serotype 6A (n=160,160)
|
1690 titer
Interval 1460.5 to 1955.9
|
1968 titer
Interval 1698.5 to 2279.3
|
—
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series
Serotype 6B (n=156,155)
|
1990 titer
Interval 1611.7 to 2456.9
|
2014 titer
Interval 1639.1 to 2475.4
|
—
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series
Serotype 7F (n=159,160)
|
2891 titer
Interval 2565.4 to 3258.5
|
3450 titer
Interval 3014.7 to 3947.9
|
—
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series
Serotype 9V (n=158,160)
|
709 titer
Interval 600.5 to 836.2
|
706 titer
Interval 597.0 to 835.3
|
—
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series
Serotype 14 (n=157,160)
|
567 titer
Interval 415.4 to 773.5
|
786 titer
Interval 607.8 to 1015.3
|
—
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series
Serotype 18C (n=159,160)
|
2792 titer
Interval 2387.5 to 3264.8
|
1605 titer
Interval 1352.0 to 1904.4
|
—
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series
Serotype 19A (n=160,160)
|
305 titer
Interval 256.2 to 362.9
|
329 titer
Interval 284.8 to 379.8
|
—
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series
Serotype 19F (n=158,159)
|
430 titer
Interval 357.6 to 517.1
|
470 titer
Interval 391.4 to 565.3
|
—
|
|
Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series
Serotype 23F (n=159,160)
|
918 titer
Interval 729.0 to 1156.4
|
998 titer
Interval 810.6 to 1229.6
|
—
|
Adverse Events
13vPnC MDV: Informed Consent to Dose 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
13vPnC SDS: Informed Consent to Dose 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
13vPnC MDV: After Dose 1
Serious events: 0 serious events
Other events: 113 other events
Deaths: 0 deaths
13vPnC SDS: After Dose 1
Serious events: 0 serious events
Other events: 107 other events
Deaths: 0 deaths
13vPnC MDV: After Dose 2
Serious events: 0 serious events
Other events: 114 other events
Deaths: 0 deaths
13vPnC SDS: After Dose 2
Serious events: 0 serious events
Other events: 99 other events
Deaths: 0 deaths
13vPnC MDV: After Dose 3
Serious events: 1 serious events
Other events: 97 other events
Deaths: 0 deaths
13vPnC SDS: After Dose 3
Serious events: 0 serious events
Other events: 102 other events
Deaths: 0 deaths
Screened Only
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
13vPnC MDV: Informed Consent to Dose 1
n=250 participants at risk
Participants who were randomized to receive 13vPnC (PF-06414256) MDV at 8, 12, and 16 weeks of age, assessed between signing of informed consent and before Dose 1.
|
13vPnC SDS: Informed Consent to Dose 1
n=250 participants at risk
Participants who were randomized to receive 13vPnC (PF-05208760) SDS at 8, 12, and 16 weeks of age, assessed between signing of informed consent and before Dose 1.
|
13vPnC MDV: After Dose 1
n=250 participants at risk
Participants who received single 0.5 mL dose of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 1 and before Dose 2.
|
13vPnC SDS: After Dose 1
n=250 participants at risk
Participants who received single 0.5 mL dose of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 1 and before Dose 2.
|
13vPnC MDV: After Dose 2
n=249 participants at risk
Participants who received two 0.5 mL doses of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg 8, 12 weeks of age, assessed after Dose 2 and before Dose 3.
|
13vPnC SDS: After Dose 2
n=248 participants at risk
Participants who received two 0.5 mL doses of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg 8, 12 weeks of age, assessed after Dose 2 and before Dose 3.
|
13vPnC MDV: After Dose 3
n=247 participants at risk
Participants who received all three 0.5mL doses of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 3 and up to blood draw at 4 weeks.
|
13vPnC SDS: After Dose 3
n=244 participants at risk
Participants who received all three 0.5mL doses of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 3 and up to blood draw at 4 weeks.
|
Screened Only
n=26 participants at risk
Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization.
|
|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Sudden infant death syndrome
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
Other adverse events
| Measure |
13vPnC MDV: Informed Consent to Dose 1
n=250 participants at risk
Participants who were randomized to receive 13vPnC (PF-06414256) MDV at 8, 12, and 16 weeks of age, assessed between signing of informed consent and before Dose 1.
|
13vPnC SDS: Informed Consent to Dose 1
n=250 participants at risk
Participants who were randomized to receive 13vPnC (PF-05208760) SDS at 8, 12, and 16 weeks of age, assessed between signing of informed consent and before Dose 1.
|
13vPnC MDV: After Dose 1
n=250 participants at risk
Participants who received single 0.5 mL dose of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 1 and before Dose 2.
|
13vPnC SDS: After Dose 1
n=250 participants at risk
Participants who received single 0.5 mL dose of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 1 and before Dose 2.
|
13vPnC MDV: After Dose 2
n=249 participants at risk
Participants who received two 0.5 mL doses of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg 8, 12 weeks of age, assessed after Dose 2 and before Dose 3.
|
13vPnC SDS: After Dose 2
n=248 participants at risk
Participants who received two 0.5 mL doses of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg 8, 12 weeks of age, assessed after Dose 2 and before Dose 3.
|
13vPnC MDV: After Dose 3
n=247 participants at risk
Participants who received all three 0.5mL doses of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 3 and up to blood draw at 4 weeks.
|
13vPnC SDS: After Dose 3
n=244 participants at risk
Participants who received all three 0.5mL doses of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 3 and up to blood draw at 4 weeks.
|
Screened Only
n=26 participants at risk
Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization.
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
1.6%
4/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
7.7%
2/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
1.2%
3/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
1.2%
3/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
1.2%
3/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
1.6%
4/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
1.2%
3/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
3.8%
1/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.40%
1/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
10.8%
27/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
6.8%
17/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
6.8%
17/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
4.0%
10/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
7.7%
19/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
10.2%
25/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Infections and infestations
Viral diarrhoea
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
2.4%
6/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
4.0%
10/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
3.2%
8/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
4.0%
10/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
2.0%
5/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
4.1%
10/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Infections and infestations
Tinea capitis
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
1.6%
4/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
1.2%
3/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
1.2%
3/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.81%
2/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.41%
1/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Infections and infestations
Viral infection
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
1.2%
3/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
1.2%
3/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
1.6%
4/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Infections and infestations
Otitis media
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.80%
2/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.80%
2/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
1.2%
3/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.82%
2/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Infections and infestations
Breast abscess
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Infections and infestations
Dysentery
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.41%
1/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Infections and infestations
Injection site abscess
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
1.2%
3/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
2.4%
6/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
1.2%
3/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Infections and infestations
Tinea infection
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Infections and infestations
Rash pustular
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Infections and infestations
Tinea faciei
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Infections and infestations
Furuncle
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
1.2%
3/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Infections and infestations
Impetigo
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.81%
2/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.41%
1/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.41%
1/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.82%
2/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Infections and infestations
Chest wall abscess
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Infections and infestations
Varicella
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.41%
1/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
11.5%
3/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.40%
1/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
3.2%
8/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
4.8%
12/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
2.0%
5/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
2.8%
7/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.81%
2/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
2.5%
6/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.82%
2/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.41%
1/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Pregnancy, puerperium and perinatal conditions
Umbilical granuloma
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.80%
2/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.80%
2/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.80%
2/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.41%
1/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
1.2%
3/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
General disorders
Pyrexia
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.80%
2/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.41%
1/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
General disorders
Vaccination site swelling
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
General disorders
Ulcer
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Skin and subcutaneous tissue disorders
Redness: Any
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.81%
2/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/246 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/241 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Skin and subcutaneous tissue disorders
Redness: Mild
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.81%
2/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/246 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/241 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Skin and subcutaneous tissue disorders
Redness: Moderate
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/246 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/241 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Skin and subcutaneous tissue disorders
Redness: Severe
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/246 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/241 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Skin and subcutaneous tissue disorders
Swelling: Any
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.81%
2/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/246 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/241 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Skin and subcutaneous tissue disorders
Swelling: Mild
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.81%
2/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/246 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/241 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Skin and subcutaneous tissue disorders
Swelling: Moderate
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/246 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/241 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Skin and subcutaneous tissue disorders
Swelling: Severe
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/246 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/241 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Skin and subcutaneous tissue disorders
Tenderness: Any
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
16.9%
42/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
18.8%
47/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
13.7%
34/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
13.0%
32/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
15.0%
37/246 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
14.5%
35/241 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Skin and subcutaneous tissue disorders
Tenderness: Mild
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
12.9%
32/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
14.8%
37/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
10.9%
27/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
11.3%
28/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
12.2%
30/246 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
13.3%
32/241 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Skin and subcutaneous tissue disorders
Tenderness: Moderate
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
5.2%
13/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
5.6%
14/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
2.8%
7/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
2.0%
5/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
3.7%
9/246 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
1.7%
4/241 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Skin and subcutaneous tissue disorders
Tenderness: Severe
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/246 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/241 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
General disorders
Fever: >=38.0 degree C
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
3.6%
9/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
2.8%
7/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
2.8%
7/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
2.8%
7/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
1.2%
3/246 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
3.3%
8/241 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
General disorders
Fever: >=38.0 but <=39.0 degrees C
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
3.6%
9/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
2.8%
7/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
2.8%
7/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
2.8%
7/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
1.2%
3/246 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
2.9%
7/241 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
General disorders
Fever: >39.0 but <=40.0 degrees C
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/246 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.41%
1/241 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
General disorders
Fever: >40.0 degrees C
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/246 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/241 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
General disorders
Decreased appetite: Any
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
6.9%
17/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
10.4%
26/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
11.3%
28/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
7.3%
18/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
9.8%
24/246 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
8.3%
20/242 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
General disorders
Decreased appetite: Moderate
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
6.9%
17/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
10.4%
26/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
11.3%
28/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
7.3%
18/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
9.8%
24/246 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
7.9%
19/242 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
General disorders
Decreased appetite: Severe
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/246 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.41%
1/241 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
General disorders
Irritability: Any
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
41.4%
103/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
37.2%
93/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
37.5%
93/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
33.6%
83/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
33.7%
83/246 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
37.9%
92/243 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
General disorders
Irritability: Mild
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
34.5%
86/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
30.8%
77/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
30.2%
75/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
27.1%
67/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
28.9%
71/246 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
30.6%
74/242 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
General disorders
Irritability: Moderate
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
7.7%
19/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
6.8%
17/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
9.3%
23/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
6.9%
17/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
6.1%
15/246 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
7.4%
18/242 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
General disorders
Irritability: Severe
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
1.2%
3/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.41%
1/246 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
2.1%
5/241 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
General disorders
Increased sleep: Any
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
6.5%
16/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
5.6%
14/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
9.7%
24/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
5.7%
14/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
4.9%
12/246 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
5.0%
12/241 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
General disorders
Increased sleep: Mild
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
4.4%
11/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
4.0%
10/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
8.1%
20/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
4.9%
12/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
4.1%
10/246 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
4.6%
11/241 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
General disorders
Increased sleep: Moderate
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
2.4%
6/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
1.6%
4/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
1.6%
4/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.81%
2/246 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.41%
1/241 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
General disorders
Increased sleep: Severe
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
—
0/0 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.40%
1/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.41%
1/246 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/241 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Congenital, familial and genetic disorders
Heart disease congenital
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
3.8%
1/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
3.8%
1/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
|
Musculoskeletal and connective tissue disorders
Growth retardation
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/250 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/249 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/248 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/247 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
0.00%
0/244 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
3.8%
1/26 • Adverse events (AEs)/serious AEs (SAEs): recorded from signing of informed consent form to 28 to 42 days after dose 3. Pre-specified AEs were recorded in an electronic diary: local reactions, systemic events (Day 2 to Day 6 after each vaccination)
SAEs, AEs grouped by system organ class and summarized. AEs included AEs collected in electronic diary (local, systemic reactions;systematic assessment), events collected on case report form at each visit (non-systematic assessment). AEs also reported in participants who provided consent but were not randomized (reported under 'Screened Only' arm).
|
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