Trial Outcomes & Findings for A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Infants and Young Children (NCT NCT03574389)
NCT ID: NCT03574389
Last Updated: 2024-11-05
Results Overview
Serotype-specific IgG concentrations to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all participants from the blood samples taken 1 month after the infant series in Cohort 1 and the last dose 13vPnC in Cohorts 2, 3, 4. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
936 participants
Primary outcome timeframe
Cohort 1: 1 month after the 3rd dose of 13vPnC (infant series dose). Cohort 2, 3, 4: 1 month after the last dose of 13vPnC.
Results posted on
2024-11-05
Participant Flow
This study presents results following completion of all vaccinations, including data from 6-month follow-up after the last study vaccination. This study was conducted in China.
With the 280 additional participants included, a total of 986 participants were screened in this study, of whom 936 participants were enrolled or randomized, and 932 of 936 participants were vaccinated.
Participant milestones
| Measure |
Cohort 1
Participants vaccinated 4 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 42 to 56 days of age; Vaccination 2 (Visit 2): 42 to 70 days after Visit 1; Vaccination 3 (Visit 3): 42 to 70 days after Visit 2; Vaccination 4: 365 to 455 days of age.
|
Cohort 2_13vPnC
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 2_Hib Vaccine
Participants vaccinated 2 doses of Hib Vaccine (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2: at least 28 days after Visit 1.
|
Cohort 3_13vPnC
Participants vaccinated 2 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): \>=1 to \<2 years of age; Vaccination 2: at least 56 days after Visit 1.
|
Cohort 3_Hib Vaccine
Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=1 to \<2 years of age.
|
Cohort 4_13vPnC
Participants vaccinated 1 dose of 13vPnC (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 4_Hib Vaccine
Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
|---|---|---|---|---|---|---|---|
|
Vaccination Period
STARTED
|
125
|
236
|
117
|
165
|
83
|
138
|
68
|
|
Vaccination Period
Vaccination 1
|
125
|
236
|
117
|
165
|
83
|
138
|
68
|
|
Vaccination Period
Vaccination 2
|
114
|
219
|
107
|
146
|
0
|
0
|
0
|
|
Vaccination Period
Vaccination 3
|
111
|
214
|
0
|
0
|
0
|
0
|
0
|
|
Vaccination Period
Vaccination 4
|
92
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Vaccination Period
COMPLETED
|
90
|
214
|
107
|
146
|
83
|
138
|
68
|
|
Vaccination Period
NOT COMPLETED
|
35
|
22
|
10
|
19
|
0
|
0
|
0
|
|
Follow-up Period
STARTED
|
90
|
214
|
107
|
146
|
83
|
138
|
68
|
|
Follow-up Period
COMPLETED
|
89
|
201
|
98
|
137
|
76
|
131
|
67
|
|
Follow-up Period
NOT COMPLETED
|
1
|
13
|
9
|
9
|
7
|
7
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1
Participants vaccinated 4 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 42 to 56 days of age; Vaccination 2 (Visit 2): 42 to 70 days after Visit 1; Vaccination 3 (Visit 3): 42 to 70 days after Visit 2; Vaccination 4: 365 to 455 days of age.
|
Cohort 2_13vPnC
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 2_Hib Vaccine
Participants vaccinated 2 doses of Hib Vaccine (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2: at least 28 days after Visit 1.
|
Cohort 3_13vPnC
Participants vaccinated 2 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): \>=1 to \<2 years of age; Vaccination 2: at least 56 days after Visit 1.
|
Cohort 3_Hib Vaccine
Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=1 to \<2 years of age.
|
Cohort 4_13vPnC
Participants vaccinated 1 dose of 13vPnC (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 4_Hib Vaccine
Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
|---|---|---|---|---|---|---|---|
|
Vaccination Period
Noncompliance With Investigational Product
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Vaccination Period
Withdrawal by Parent/guardian
|
26
|
21
|
10
|
19
|
0
|
0
|
0
|
|
Vaccination Period
Other
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Vaccination Period
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Follow-up Period
Withdrawal by parent/guardian
|
1
|
13
|
9
|
9
|
7
|
7
|
1
|
Baseline Characteristics
The ages of participants in Cohort 1 and 2 were counted in different 'Unit of Measures' from Cohort 3 and 4, and thus they were reported in separated 'Baseline Measures'. Cohort 1 and 2 were reported here.
Baseline characteristics by cohort
| Measure |
Cohort 1
n=125 Participants
Participants vaccinated the first 3 of doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 42 to 56 days of age; Vaccination 2 (Visit 2): 42 to 70 days after Visit 1; Vaccination 3: 42 to 70 days after Visit 2; Vaccination 4: 365 to 455 days of age.
|
Cohort 2_13vPnC
n=236 Participants
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 2_Hib Vaccine
n=117 Participants
Participants vaccinated 2 doses of Hib Vaccine (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2: at least 28 days after Visit 1.
|
Cohort 3_13vPnC
n=165 Participants
Participants vaccinated 2 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): \>=1 to \<2 years of age; Vaccination 2: at least 56 days after Visit 1.
|
Cohort 3_Hib Vaccine
n=83 Participants
Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=1 to \<2 years of age.
|
Cohort 4_13vPnC
n=138 Participants
Participants vaccinated 1 dose of 13vPnC (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 4_Hib Vaccine
n=68 Participants
Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Total
n=932 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
49.0 Days
n=125 Participants • The ages of participants in Cohort 1 and 2 were counted in different 'Unit of Measures' from Cohort 3 and 4, and thus they were reported in separated 'Baseline Measures'. Cohort 1 and 2 were reported here.
|
284.0 Days
n=236 Participants • The ages of participants in Cohort 1 and 2 were counted in different 'Unit of Measures' from Cohort 3 and 4, and thus they were reported in separated 'Baseline Measures'. Cohort 1 and 2 were reported here.
|
281.0 Days
n=117 Participants • The ages of participants in Cohort 1 and 2 were counted in different 'Unit of Measures' from Cohort 3 and 4, and thus they were reported in separated 'Baseline Measures'. Cohort 1 and 2 were reported here.
|
1.5 Years
n=165 Participants • The ages of participants in Cohort 1 and 2 were counted in different 'Unit of Measures' from Cohort 3 and 4, and thus they were reported in separated 'Baseline Measures'. Cohort 3 and 4 were reported here.
|
1.6 Years
n=83 Participants • The ages of participants in Cohort 1 and 2 were counted in different 'Unit of Measures' from Cohort 3 and 4, and thus they were reported in separated 'Baseline Measures'. Cohort 3 and 4 were reported here.
|
3.1 Years
n=138 Participants • The ages of participants in Cohort 1 and 2 were counted in different 'Unit of Measures' from Cohort 3 and 4, and thus they were reported in separated 'Baseline Measures'. Cohort 3 and 4 were reported here.
|
3.3 Years
n=68 Participants • The ages of participants in Cohort 1 and 2 were counted in different 'Unit of Measures' from Cohort 3 and 4, and thus they were reported in separated 'Baseline Measures'. Cohort 3 and 4 were reported here.
|
1.9 Years
n=454 Participants • The ages of participants in Cohort 1 and 2 were counted in different 'Unit of Measures' from Cohort 3 and 4, and thus they were reported in separated 'Baseline Measures'. Cohort 3 and 4 were reported here.
|
|
Sex: Female, Male
Female
|
59 Participants
n=125 Participants
|
115 Participants
n=236 Participants
|
50 Participants
n=117 Participants
|
83 Participants
n=165 Participants
|
36 Participants
n=83 Participants
|
56 Participants
n=138 Participants
|
37 Participants
n=68 Participants
|
436 Participants
n=932 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=125 Participants
|
121 Participants
n=236 Participants
|
67 Participants
n=117 Participants
|
82 Participants
n=165 Participants
|
47 Participants
n=83 Participants
|
82 Participants
n=138 Participants
|
31 Participants
n=68 Participants
|
496 Participants
n=932 Participants
|
|
Race/Ethnicity, Customized
Race_Asian
|
125 Participants
n=125 Participants
|
236 Participants
n=236 Participants
|
117 Participants
n=117 Participants
|
165 Participants
n=165 Participants
|
83 Participants
n=83 Participants
|
138 Participants
n=138 Participants
|
68 Participants
n=68 Participants
|
932 Participants
n=932 Participants
|
|
Race/Ethnicity, Customized
Ethnicity_Non-Hispanic/Non-Latino
|
125 Participants
n=125 Participants
|
236 Participants
n=236 Participants
|
117 Participants
n=117 Participants
|
165 Participants
n=165 Participants
|
83 Participants
n=83 Participants
|
138 Participants
n=138 Participants
|
68 Participants
n=68 Participants
|
932 Participants
n=932 Participants
|
PRIMARY outcome
Timeframe: Cohort 1: 1 month after the 3rd dose of 13vPnC (infant series dose). Cohort 2, 3, 4: 1 month after the last dose of 13vPnC.Population: Evaluable analysis set included all participants evaluable for the study at randomization; received all study vaccinations for Cohort 2-4, received all 3 infant series doses for Cohort 1; had blood draw for assay testing within 27-56 days after 3rd vaccination for Cohort 1, visit 3 for Cohort 2, visit 2 for Cohort 3 and visit 1 for Cohort 4 and the sample from this blood draw provided at least 1 valid and determinate assay result; received no prohibited vaccine; had no major protocol violation.
Serotype-specific IgG concentrations to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all participants from the blood samples taken 1 month after the infant series in Cohort 1 and the last dose 13vPnC in Cohorts 2, 3, 4. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Outcome measures
| Measure |
Cohort 1_Infant Series
n=72 Participants
Participants vaccinated 3 infant series doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 42 to 56 days of age; Vaccination 2 (Visit 2): 42 to 70 days after Visit 1; Vaccination 3: 42 to 70 days after Visit 2.
|
Cohort 2_13vPnC
n=176 Participants
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 3_13vPnC
n=127 Participants
Participants vaccinated 2 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): \>=1 to \<2 years of age; Vaccination 2: at least 56 days after Visit 1.
|
Cohort 4_vPnC
n=131 Participants
Participants vaccinated 1 dose of 13vPnC (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 2_13vPnC_Vaccination 3
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 4_Hib Vaccine
Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 4_Hib Vaccine
Proportion of participants achieving pneumococcal serotype-specific IgG concentration \>=0.35 µg/mL for 1 month after the last dose of Hib vaccine in Cohort 4.
|
|---|---|---|---|---|---|---|---|
|
The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1
Serotype 1
|
5.40 mcg/mL
Interval 4.43 to 6.58
|
3.75 mcg/mL
Interval 3.26 to 4.32
|
4.38 mcg/mL
Interval 3.75 to 5.11
|
4.40 mcg/mL
Interval 3.76 to 5.14
|
—
|
—
|
—
|
|
The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1
Serotype 3
|
0.63 mcg/mL
Interval 0.54 to 0.75
|
1.19 mcg/mL
Interval 1.08 to 1.32
|
1.32 mcg/mL
Interval 1.16 to 1.51
|
1.12 mcg/mL
Interval 0.97 to 1.29
|
—
|
—
|
—
|
|
The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1
Serotype 4
|
3.96 mcg/mL
Interval 3.24 to 4.84
|
2.97 mcg/mL
Interval 2.6 to 3.4
|
4.04 mcg/mL
Interval 3.48 to 4.68
|
4.47 mcg/mL
Interval 3.92 to 5.1
|
—
|
—
|
—
|
|
The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1
Serotype 5
|
3.50 mcg/mL
Interval 2.91 to 4.19
|
3.07 mcg/mL
Interval 2.73 to 3.46
|
2.57 mcg/mL
Interval 2.26 to 2.92
|
2.92 mcg/mL
Interval 2.57 to 3.32
|
—
|
—
|
—
|
|
The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1
Serotype 6A
|
5.35 mcg/mL
Interval 4.44 to 6.44
|
3.12 mcg/mL
Interval 2.74 to 3.57
|
3.19 mcg/mL
Interval 2.69 to 3.78
|
3.39 mcg/mL
Interval 2.8 to 4.09
|
—
|
—
|
—
|
|
The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1
Serotype 6B
|
4.62 mcg/mL
Interval 3.76 to 5.69
|
2.20 mcg/mL
Interval 1.91 to 2.54
|
2.47 mcg/mL
Interval 2.06 to 2.96
|
2.96 mcg/mL
Interval 2.44 to 3.59
|
—
|
—
|
—
|
|
The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1
Serotype 7F
|
7.14 mcg/mL
Interval 6.0 to 8.5
|
5.73 mcg/mL
Interval 5.1 to 6.44
|
7.87 mcg/mL
Interval 6.9 to 8.96
|
7.08 mcg/mL
Interval 6.19 to 8.1
|
—
|
—
|
—
|
|
The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1
Serotype 9V
|
3.66 mcg/mL
Interval 2.99 to 4.5
|
2.24 mcg/mL
Interval 1.99 to 2.51
|
3.31 mcg/mL
Interval 2.9 to 3.77
|
3.68 mcg/mL
Interval 3.22 to 4.21
|
—
|
—
|
—
|
|
The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1
Serotype 14
|
15.09 mcg/mL
Interval 11.39 to 20.0
|
10.89 mcg/mL
Interval 9.59 to 12.35
|
9.79 mcg/mL
Interval 8.4 to 11.41
|
6.94 mcg/mL
Interval 5.53 to 8.7
|
—
|
—
|
—
|
|
The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1
Serotype 18C
|
4.94 mcg/mL
Interval 4.11 to 5.94
|
2.25 mcg/mL
Interval 1.98 to 2.57
|
3.88 mcg/mL
Interval 3.25 to 4.64
|
5.60 mcg/mL
Interval 4.74 to 6.62
|
—
|
—
|
—
|
|
The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1
Serotype 19A
|
3.44 mcg/mL
Interval 2.85 to 4.16
|
3.62 mcg/mL
Interval 3.3 to 3.97
|
5.55 mcg/mL
Interval 4.86 to 6.34
|
11.62 mcg/mL
Interval 9.75 to 13.86
|
—
|
—
|
—
|
|
The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1
Serotype 19F
|
4.95 mcg/mL
Interval 3.91 to 6.26
|
4.50 mcg/mL
Interval 3.98 to 5.09
|
5.04 mcg/mL
Interval 4.28 to 5.92
|
5.44 mcg/mL
Interval 4.46 to 6.64
|
—
|
—
|
—
|
|
The Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMCs Measured in Cohort 1
Serotype 23F
|
4.36 mcg/mL
Interval 3.23 to 5.88
|
2.04 mcg/mL
Interval 1.76 to 2.37
|
2.26 mcg/mL
Interval 1.9 to 2.67
|
2.80 mcg/mL
Interval 2.33 to 3.36
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 Days After Each VaccinationPopulation: The safety population included all participants who received at least 1 dose of the investigational product.
Local reactions (redness, swelling, and tenderness) at the site of the investigational product injection were monitored daily for 7 days after each vaccination. Temperature were collected at bedtime daily for 7 days and at any time during the 7 days that fever is suspected. Fever is defined as temperature of greater than or equal to 38.0ºC (100.4ºF). Other systemic events (decreased appetite, drowsiness and irritability) were recorded for 7 days after each investigational product vaccination.
Outcome measures
| Measure |
Cohort 1_Infant Series
n=236 Participants
Participants vaccinated 3 infant series doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 42 to 56 days of age; Vaccination 2 (Visit 2): 42 to 70 days after Visit 1; Vaccination 3: 42 to 70 days after Visit 2.
|
Cohort 2_13vPnC
n=117 Participants
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 3_13vPnC
n=219 Participants
Participants vaccinated 2 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): \>=1 to \<2 years of age; Vaccination 2: at least 56 days after Visit 1.
|
Cohort 4_vPnC
n=107 Participants
Participants vaccinated 1 dose of 13vPnC (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 2_13vPnC_Vaccination 3
n=194 Participants
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 4_Hib Vaccine
Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 4_Hib Vaccine
Proportion of participants achieving pneumococcal serotype-specific IgG concentration \>=0.35 µg/mL for 1 month after the last dose of Hib vaccine in Cohort 4.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 2
Local Reactions
|
66 Participants
|
18 Participants
|
20 Participants
|
14 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 2
Systemic Events
|
23 Participants
|
7 Participants
|
23 Participants
|
5 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 Days After Each VaccinationPopulation: The safety population included all participants who received at least 1 dose of the investigational product.
Local reactions (redness, swelling, and tenderness) at the site of the investigational product injection were monitored daily for 7 days after each vaccination. Temperature were collected at bedtime daily for 7 days and at any time during the 7 days that fever is suspected. Fever is defined as temperature of greater than or equal to 38.0ºC (100.4ºF). Other systemic events (decreased appetite, drowsiness and irritability) were recorded for 7 days after each investigational product vaccination.
Outcome measures
| Measure |
Cohort 1_Infant Series
n=164 Participants
Participants vaccinated 3 infant series doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 42 to 56 days of age; Vaccination 2 (Visit 2): 42 to 70 days after Visit 1; Vaccination 3: 42 to 70 days after Visit 2.
|
Cohort 2_13vPnC
n=83 Participants
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 3_13vPnC
n=146 Participants
Participants vaccinated 2 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): \>=1 to \<2 years of age; Vaccination 2: at least 56 days after Visit 1.
|
Cohort 4_vPnC
Participants vaccinated 1 dose of 13vPnC (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 2_13vPnC_Vaccination 3
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 4_Hib Vaccine
Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 4_Hib Vaccine
Proportion of participants achieving pneumococcal serotype-specific IgG concentration \>=0.35 µg/mL for 1 month after the last dose of Hib vaccine in Cohort 4.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 3
Local Reactions
|
45 Participants
|
10 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 3
Systemic Events
|
26 Participants
|
7 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 Days After Each VaccinationPopulation: The safety population included all participants who received at least 1 dose of the investigational product.
Local reactions (redness, swelling, and tenderness) at the site of the investigational product injection were monitored daily for 7 days after each vaccination. Temperature were collected at bedtime daily for 7 days and at any time during the 7 days that fever is suspected. Fever is defined as temperature of greater than or equal to 38.0ºC (100.4ºF). Other systemic events (fatigue, headache, vomiting, diarrhea, muscle pain and joint pain) were recorded for 7 days after each investigational product vaccination.
Outcome measures
| Measure |
Cohort 1_Infant Series
n=138 Participants
Participants vaccinated 3 infant series doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 42 to 56 days of age; Vaccination 2 (Visit 2): 42 to 70 days after Visit 1; Vaccination 3: 42 to 70 days after Visit 2.
|
Cohort 2_13vPnC
n=68 Participants
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 3_13vPnC
Participants vaccinated 2 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): \>=1 to \<2 years of age; Vaccination 2: at least 56 days after Visit 1.
|
Cohort 4_vPnC
Participants vaccinated 1 dose of 13vPnC (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 2_13vPnC_Vaccination 3
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 4_Hib Vaccine
Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 4_Hib Vaccine
Proportion of participants achieving pneumococcal serotype-specific IgG concentration \>=0.35 µg/mL for 1 month after the last dose of Hib vaccine in Cohort 4.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 4
Local Reactions
|
48 Participants
|
21 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Local Reactions and Systemic Events Within 7 Days After Each Vaccination in Cohort 4
Systemic Events
|
17 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the signing of ICD to 1 month after the last vaccination (13vPnC or Hib) in Cohort 2, 3 and 4.Population: The safety population included all participants who received at least 1 dose of the investigational product.
An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.
Outcome measures
| Measure |
Cohort 1_Infant Series
n=236 Participants
Participants vaccinated 3 infant series doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 42 to 56 days of age; Vaccination 2 (Visit 2): 42 to 70 days after Visit 1; Vaccination 3: 42 to 70 days after Visit 2.
|
Cohort 2_13vPnC
n=117 Participants
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 3_13vPnC
n=165 Participants
Participants vaccinated 2 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): \>=1 to \<2 years of age; Vaccination 2: at least 56 days after Visit 1.
|
Cohort 4_vPnC
n=83 Participants
Participants vaccinated 1 dose of 13vPnC (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 2_13vPnC_Vaccination 3
n=138 Participants
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 4_Hib Vaccine
n=68 Participants
Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 4_Hib Vaccine
Proportion of participants achieving pneumococcal serotype-specific IgG concentration \>=0.35 µg/mL for 1 month after the last dose of Hib vaccine in Cohort 4.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Event (AE) From the Signing of the Informed Consent Document (ICD) to 1 Month After the Last Vaccination in Cohorts 2, 3, 4
|
76 Participants
|
29 Participants
|
21 Participants
|
1 Participants
|
11 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: From 1 month to 6 months (5 months) after the last vaccination in Cohorts 2,3,4.Population: The safety population included all participants who received at least 1 dose of the investigational product.
Number of participants with NDCMCs from 1 month after the last study vaccination (13vPnC or Hib vaccine) to 6 months after the last study vaccination in Cohorts 2, 3, and 4. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
Outcome measures
| Measure |
Cohort 1_Infant Series
n=236 Participants
Participants vaccinated 3 infant series doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 42 to 56 days of age; Vaccination 2 (Visit 2): 42 to 70 days after Visit 1; Vaccination 3: 42 to 70 days after Visit 2.
|
Cohort 2_13vPnC
n=117 Participants
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 3_13vPnC
n=165 Participants
Participants vaccinated 2 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): \>=1 to \<2 years of age; Vaccination 2: at least 56 days after Visit 1.
|
Cohort 4_vPnC
n=83 Participants
Participants vaccinated 1 dose of 13vPnC (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 2_13vPnC_Vaccination 3
n=138 Participants
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 4_Hib Vaccine
n=68 Participants
Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 4_Hib Vaccine
Proportion of participants achieving pneumococcal serotype-specific IgG concentration \>=0.35 µg/mL for 1 month after the last dose of Hib vaccine in Cohort 4.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From 1 Month to 6 Months After the Last Vaccination in Cohorts 2, 3, 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: From the signing of ICD to 6 month after the last vaccination (13vPnC or Hib) in Cohorts 2, 3 and 4.Population: The safety population included all participants who received at least 1 dose of the investigational product.
An SAE was any untoward medical occurrence at any dose that resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or considered to be an important medical event.
Outcome measures
| Measure |
Cohort 1_Infant Series
n=236 Participants
Participants vaccinated 3 infant series doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 42 to 56 days of age; Vaccination 2 (Visit 2): 42 to 70 days after Visit 1; Vaccination 3: 42 to 70 days after Visit 2.
|
Cohort 2_13vPnC
n=117 Participants
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 3_13vPnC
n=165 Participants
Participants vaccinated 2 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): \>=1 to \<2 years of age; Vaccination 2: at least 56 days after Visit 1.
|
Cohort 4_vPnC
n=83 Participants
Participants vaccinated 1 dose of 13vPnC (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 2_13vPnC_Vaccination 3
n=138 Participants
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 4_Hib Vaccine
n=68 Participants
Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 4_Hib Vaccine
Proportion of participants achieving pneumococcal serotype-specific IgG concentration \>=0.35 µg/mL for 1 month after the last dose of Hib vaccine in Cohort 4.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With SAE From the Signing of the ICD to 6 Months After the Last Vaccination in Cohorts 2, 3, 4
|
5 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Cohort 1: 1 month after the 3rd dose of 13vPnC. Cohort 2, 3, 4: 1 month after the last dose of 13vPnC.Population: Evaluable analysis set included all participants evaluable for the study at randomization; received all study vaccinations for Cohort 2-4, received all 3 infant series doses for Cohort 1; had blood draw for assay testing within 27-56 days after 3rd vaccination for Cohort 1, visit 3 for Cohort 2, visit 2 for Cohort 3 and visit 1 for Cohort 4 and the sample from this blood draw provided at least 1 valid and determinate assay result; received no prohibited vaccine; had no major protocol violation.
Serotype-specific OPA titers to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in a randomly selected subset of about 50 participants receiving 13vPnC from the blood samples taken 1 month after the infant series in Cohort 1 and the last 13vPnC vaccination in each of the 3 cohorts. GMT and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Outcome measures
| Measure |
Cohort 1_Infant Series
n=37 Participants
Participants vaccinated 3 infant series doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 42 to 56 days of age; Vaccination 2 (Visit 2): 42 to 70 days after Visit 1; Vaccination 3: 42 to 70 days after Visit 2.
|
Cohort 2_13vPnC
n=87 Participants
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 3_13vPnC
n=78 Participants
Participants vaccinated 2 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): \>=1 to \<2 years of age; Vaccination 2: at least 56 days after Visit 1.
|
Cohort 4_vPnC
n=71 Participants
Participants vaccinated 1 dose of 13vPnC (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 2_13vPnC_Vaccination 3
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 4_Hib Vaccine
Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 4_Hib Vaccine
Proportion of participants achieving pneumococcal serotype-specific IgG concentration \>=0.35 µg/mL for 1 month after the last dose of Hib vaccine in Cohort 4.
|
|---|---|---|---|---|---|---|---|
|
The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1.
Serotype 1
|
201.7 GMT
Interval 134.8 to 301.8
|
142.7 GMT
Interval 103.4 to 196.9
|
93.3 GMT
Interval 70.1 to 124.1
|
40.9 GMT
Interval 31.3 to 53.4
|
—
|
—
|
—
|
|
The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1.
Serotype 3
|
112.9 GMT
Interval 82.5 to 154.4
|
249.0 GMT
Interval 205.7 to 301.5
|
332.3 GMT
Interval 273.3 to 404.1
|
244.8 GMT
Interval 192.0 to 312.1
|
—
|
—
|
—
|
|
The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1.
Serotype 4
|
1857.8 GMT
Interval 1264.8 to 2728.8
|
2172.2 GMT
Interval 1740.7 to 2710.7
|
2682.8 GMT
Interval 2210.4 to 3256.2
|
4236.3 GMT
Interval 3489.6 to 5142.8
|
—
|
—
|
—
|
|
The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1.
Serotype 5
|
645.9 GMT
Interval 452.6 to 921.8
|
286.3 GMT
Interval 214.5 to 382.0
|
164.5 GMT
Interval 131.5 to 205.7
|
79.3 GMT
Interval 57.7 to 109.0
|
—
|
—
|
—
|
|
The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1.
Serotype 6A
|
5996.2 GMT
Interval 4337.5 to 8289.3
|
6042.7 GMT
Interval 4830.2 to 7559.6
|
7661.8 GMT
Interval 6116.0 to 9598.4
|
5849.3 GMT
Interval 4364.0 to 7840.2
|
—
|
—
|
—
|
|
The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1.
Serotype 6B
|
2331.6 GMT
Interval 1481.3 to 3670.0
|
2181.6 GMT
Interval 1350.1 to 3525.2
|
4986.3 GMT
Interval 3717.6 to 6687.9
|
3775.2 GMT
Interval 2825.1 to 5044.9
|
—
|
—
|
—
|
|
The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1.
Serotype 7F
|
10413.4 GMT
Interval 7373.1 to 14707.3
|
10234.6 GMT
Interval 8612.2 to 12162.8
|
14963.5 GMT
Interval 12367.6 to 18104.4
|
17107.3 GMT
Interval 13842.7 to 21141.8
|
—
|
—
|
—
|
|
The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1.
Serotype 9V
|
5386.5 GMT
Interval 3634.0 to 7984.3
|
4154.1 GMT
Interval 3358.6 to 5138.0
|
7220.1 GMT
Interval 5620.9 to 9274.2
|
10533.5 GMT
Interval 7811.9 to 14203.4
|
—
|
—
|
—
|
|
The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1.
Serotype 14
|
2859.4 GMT
Interval 1688.9 to 4899.3
|
4108.0 GMT
Interval 3342.6 to 5048.8
|
6885.4 GMT
Interval 5642.6 to 8402.0
|
7504.5 GMT
Interval 5718.2 to 9848.9
|
—
|
—
|
—
|
|
The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1.
Serotype 18C
|
2677.9 GMT
Interval 2000.3 to 3585.0
|
1486.6 GMT
Interval 1124.6 to 1965.2
|
1890.4 GMT
Interval 1429.0 to 2500.6
|
2111.9 GMT
Interval 1630.6 to 2735.2
|
—
|
—
|
—
|
|
The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1.
Serotype 19A
|
1677.3 GMT
Interval 1159.9 to 2425.5
|
2611.3 GMT
Interval 2071.6 to 3291.6
|
3560.0 GMT
Interval 2867.8 to 4419.1
|
3055.1 GMT
Interval 2154.1 to 4333.1
|
—
|
—
|
—
|
|
The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1.
Serotype 19F
|
744.4 GMT
Interval 506.7 to 1093.6
|
1158.4 GMT
Interval 937.0 to 1432.1
|
1854.0 GMT
Interval 1520.3 to 2260.8
|
1629.7 GMT
Interval 1292.9 to 2054.2
|
—
|
—
|
—
|
|
The Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of the Pneumococcal Serotypes Measured in Cohorts 2, 3 and 4 Compared to IgG GMTs Measured in Cohort 1.
Serotype 23F
|
3833.2 GMT
Interval 2216.2 to 6630.1
|
5640.0 GMT
Interval 3590.5 to 8859.4
|
6693.6 GMT
Interval 4464.2 to 10036.4
|
4234.7 GMT
Interval 2916.1 to 6149.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 2, 3, 4: Before Vaccination and 1 Month After the Last DosePopulation: Evaluable analysis set included all participants evaluable for the study at randomization; received all study vaccinations for Cohort 2-4; had blood draw for assay testing within 27-56 days after visit 3 for Cohort 2, visit 2 for Cohort 3 and visit 1 for Cohort 4 and the sample from this blood draw provided at least 1 valid and determinate assay result; received no prohibited vaccine; had no major protocol violation.
Serotype-specific IgG concentrations to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all participants from the blood samples taken before vaccination and 1 month after vaccination in each of the 3 cohorts. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Outcome measures
| Measure |
Cohort 1_Infant Series
n=176 Participants
Participants vaccinated 3 infant series doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 42 to 56 days of age; Vaccination 2 (Visit 2): 42 to 70 days after Visit 1; Vaccination 3: 42 to 70 days after Visit 2.
|
Cohort 2_13vPnC
n=72 Participants
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 3_13vPnC
n=127 Participants
Participants vaccinated 2 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): \>=1 to \<2 years of age; Vaccination 2: at least 56 days after Visit 1.
|
Cohort 4_vPnC
n=77 Participants
Participants vaccinated 1 dose of 13vPnC (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 2_13vPnC_Vaccination 3
n=131 Participants
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 4_Hib Vaccine
n=67 Participants
Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 4_Hib Vaccine
Proportion of participants achieving pneumococcal serotype-specific IgG concentration \>=0.35 µg/mL for 1 month after the last dose of Hib vaccine in Cohort 4.
|
|---|---|---|---|---|---|---|---|
|
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 1 - Before Vaccination
|
0.02 mcg/mL
Interval 0.01 to 0.02
|
0.02 mcg/mL
Interval 0.01 to 0.03
|
0.07 mcg/mL
Interval 0.05 to 0.09
|
0.07 mcg/mL
Interval 0.05 to 0.1
|
0.18 mcg/mL
Interval 0.14 to 0.22
|
0.21 mcg/mL
Interval 0.15 to 0.28
|
—
|
|
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 1 - 1 Month After the Last Dose
|
3.75 mcg/mL
Interval 3.26 to 4.32
|
0.04 mcg/mL
Interval 0.03 to 0.06
|
4.38 mcg/mL
Interval 3.75 to 5.11
|
0.07 mcg/mL
Interval 0.04 to 0.11
|
4.40 mcg/mL
Interval 3.76 to 5.14
|
0.16 mcg/mL
Interval 0.12 to 0.23
|
—
|
|
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 3 - Before Vaccination
|
0.03 mcg/mL
Interval 0.03 to 0.04
|
0.03 mcg/mL
Interval 0.02 to 0.04
|
0.07 mcg/mL
Interval 0.05 to 0.09
|
0.07 mcg/mL
Interval 0.05 to 0.09
|
0.14 mcg/mL
Interval 0.1 to 0.18
|
0.13 mcg/mL
Interval 0.08 to 0.22
|
—
|
|
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 3 - 1 Month After the Last Dose
|
1.19 mcg/mL
Interval 1.08 to 1.32
|
0.04 mcg/mL
Interval 0.03 to 0.05
|
1.32 mcg/mL
Interval 1.16 to 1.51
|
0.09 mcg/mL
Interval 0.06 to 0.13
|
1.12 mcg/mL
Interval 0.97 to 1.29
|
0.12 mcg/mL
Interval 0.07 to 0.2
|
—
|
|
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 4 - Before Vaccination
|
0.01 mcg/mL
Interval 0.01 to 0.01
|
0.01 mcg/mL
Interval 0.01 to 0.01
|
0.03 mcg/mL
Interval 0.02 to 0.04
|
0.04 mcg/mL
Interval 0.03 to 0.06
|
0.07 mcg/mL
Interval 0.05 to 0.1
|
0.07 mcg/mL
Interval 0.05 to 0.11
|
—
|
|
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 4 - 1 Month After the Last Dose
|
2.97 mcg/mL
Interval 2.6 to 3.4
|
0.02 mcg/mL
Interval 0.01 to 0.02
|
4.04 mcg/mL
Interval 3.48 to 4.68
|
0.03 mcg/mL
Interval 0.02 to 0.05
|
4.47 mcg/mL
Interval 3.92 to 5.1
|
0.06 mcg/mL
Interval 0.04 to 0.08
|
—
|
|
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 5 - Before Vaccination
|
0.38 mcg/mL
Interval 0.34 to 0.43
|
0.36 mcg/mL
Interval 0.31 to 0.42
|
0.69 mcg/mL
Interval 0.6 to 0.78
|
0.63 mcg/mL
Interval 0.54 to 0.74
|
1.04 mcg/mL
Interval 0.92 to 1.17
|
0.97 mcg/mL
Interval 0.83 to 1.13
|
—
|
|
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 5 - 1 Month After the Last Dose
|
3.07 mcg/mL
Interval 2.73 to 3.46
|
0.51 mcg/mL
Interval 0.43 to 0.61
|
2.57 mcg/mL
Interval 2.26 to 2.92
|
0.74 mcg/mL
Interval 0.62 to 0.88
|
2.92 mcg/mL
Interval 2.57 to 3.32
|
0.89 mcg/mL
Interval 0.73 to 1.07
|
—
|
|
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 6A - Before Vaccination
|
0.15 mcg/mL
Interval 0.13 to 0.18
|
0.16 mcg/mL
Interval 0.13 to 0.2
|
0.30 mcg/mL
Interval 0.26 to 0.35
|
0.36 mcg/mL
Interval 0.3 to 0.42
|
0.79 mcg/mL
Interval 0.68 to 0.93
|
0.79 mcg/mL
Interval 0.64 to 0.97
|
—
|
|
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 6A - 1 Month After the Last Dose
|
3.12 mcg/mL
Interval 2.74 to 3.57
|
0.20 mcg/mL
Interval 0.15 to 0.26
|
3.19 mcg/mL
Interval 2.69 to 3.78
|
0.42 mcg/mL
Interval 0.34 to 0.51
|
3.39 mcg/mL
Interval 2.8 to 4.09
|
0.80 mcg/mL
Interval 0.65 to 0.98
|
—
|
|
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 6B - Before Vaccination
|
0.15 mcg/mL
Interval 0.12 to 0.17
|
0.15 mcg/mL
Interval 0.11 to 0.19
|
0.30 mcg/mL
Interval 0.26 to 0.35
|
0.35 mcg/mL
Interval 0.3 to 0.41
|
0.80 mcg/mL
Interval 0.69 to 0.94
|
0.70 mcg/mL
Interval 0.58 to 0.84
|
—
|
|
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 6B - 1 Month After the Last Dose
|
2.20 mcg/mL
Interval 1.91 to 2.54
|
0.21 mcg/mL
Interval 0.16 to 0.26
|
2.47 mcg/mL
Interval 2.06 to 2.96
|
0.38 mcg/mL
Interval 0.32 to 0.46
|
2.96 mcg/mL
Interval 2.44 to 3.59
|
0.62 mcg/mL
Interval 0.49 to 0.79
|
—
|
|
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 7F - Before Vaccination
|
0.03 mcg/mL
Interval 0.03 to 0.04
|
0.03 mcg/mL
Interval 0.02 to 0.04
|
0.10 mcg/mL
Interval 0.08 to 0.12
|
0.11 mcg/mL
Interval 0.08 to 0.15
|
0.25 mcg/mL
Interval 0.21 to 0.31
|
0.25 mcg/mL
Interval 0.18 to 0.33
|
—
|
|
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 7F - 1 Month After the Last Dose
|
5.73 mcg/mL
Interval 5.1 to 6.44
|
0.05 mcg/mL
Interval 0.03 to 0.07
|
7.87 mcg/mL
Interval 6.9 to 8.96
|
0.13 mcg/mL
Interval 0.09 to 0.2
|
7.08 mcg/mL
Interval 6.19 to 8.1
|
0.21 mcg/mL
Interval 0.16 to 0.29
|
—
|
|
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 9V - Before Vaccination
|
0.13 mcg/mL
Interval 0.11 to 0.16
|
0.16 mcg/mL
Interval 0.12 to 0.22
|
0.25 mcg/mL
Interval 0.2 to 0.31
|
0.27 mcg/mL
Interval 0.23 to 0.33
|
0.55 mcg/mL
Interval 0.47 to 0.65
|
0.41 mcg/mL
Interval 0.31 to 0.55
|
—
|
|
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 9V - 1 Month After the Last Dose
|
2.24 mcg/mL
Interval 1.99 to 2.51
|
0.20 mcg/mL
Interval 0.14 to 0.27
|
3.31 mcg/mL
Interval 2.9 to 3.77
|
0.34 mcg/mL
Interval 0.26 to 0.43
|
3.68 mcg/mL
Interval 3.22 to 4.21
|
0.45 mcg/mL
Interval 0.37 to 0.54
|
—
|
|
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 14 - Before Vaccination
|
0.03 mcg/mL
Interval 0.02 to 0.04
|
0.02 mcg/mL
Interval 0.02 to 0.03
|
0.03 mcg/mL
Interval 0.03 to 0.05
|
0.05 mcg/mL
Interval 0.03 to 0.09
|
0.19 mcg/mL
Interval 0.12 to 0.29
|
0.20 mcg/mL
Interval 0.11 to 0.36
|
—
|
|
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 14 - 1 Month After the Last Dose
|
10.89 mcg/mL
Interval 9.59 to 12.35
|
0.02 mcg/mL
Interval 0.02 to 0.03
|
9.79 mcg/mL
Interval 8.4 to 11.41
|
0.07 mcg/mL
Interval 0.04 to 0.11
|
6.94 mcg/mL
Interval 5.53 to 8.7
|
0.20 mcg/mL
Interval 0.11 to 0.36
|
—
|
|
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 18C - Before Vaccination
|
0.01 mcg/mL
Interval 0.01 to 0.01
|
0.01 mcg/mL
Interval 0.01 to 0.02
|
0.04 mcg/mL
Interval 0.03 to 0.06
|
0.05 mcg/mL
Interval 0.04 to 0.08
|
0.20 mcg/mL
Interval 0.15 to 0.27
|
0.20 mcg/mL
Interval 0.12 to 0.29
|
—
|
|
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 18C - 1 Month After the Last Dose
|
2.25 mcg/mL
Interval 1.98 to 2.57
|
0.02 mcg/mL
Interval 0.01 to 0.03
|
3.88 mcg/mL
Interval 3.25 to 4.64
|
0.07 mcg/mL
Interval 0.04 to 0.12
|
5.60 mcg/mL
Interval 4.74 to 6.62
|
0.18 mcg/mL
Interval 0.11 to 0.29
|
—
|
|
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 19A - Before Vaccination
|
0.36 mcg/mL
Interval 0.31 to 0.41
|
0.38 mcg/mL
Interval 0.31 to 0.46
|
0.65 mcg/mL
Interval 0.55 to 0.76
|
0.69 mcg/mL
Interval 0.58 to 0.83
|
1.72 mcg/mL
Interval 1.46 to 2.02
|
1.44 mcg/mL
Interval 1.13 to 1.83
|
—
|
|
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 19A - 1 Month After the Last Dose
|
3.62 mcg/mL
Interval 3.3 to 3.97
|
0.50 mcg/mL
Interval 0.41 to 0.6
|
5.55 mcg/mL
Interval 4.86 to 6.34
|
0.88 mcg/mL
Interval 0.71 to 1.1
|
11.62 mcg/mL
Interval 9.75 to 13.86
|
1.33 mcg/mL
Interval 1.04 to 1.7
|
—
|
|
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 19F - Before Vaccination
|
0.08 mcg/mL
Interval 0.07 to 0.11
|
0.11 mcg/mL
Interval 0.08 to 0.16
|
0.23 mcg/mL
Interval 0.18 to 0.29
|
0.23 mcg/mL
Interval 0.17 to 0.31
|
0.62 mcg/mL
Interval 0.49 to 0.78
|
0.57 mcg/mL
Interval 0.41 to 0.8
|
—
|
|
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 19F - 1 Month After the Last Dose
|
4.50 mcg/mL
Interval 3.98 to 5.09
|
0.13 mcg/mL
Interval 0.09 to 0.19
|
5.04 mcg/mL
Interval 4.28 to 5.92
|
0.27 mcg/mL
Interval 0.18 to 0.39
|
5.44 mcg/mL
Interval 4.46 to 6.64
|
0.53 mcg/mL
Interval 0.38 to 0.73
|
—
|
|
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 23F - Before Vaccination
|
0.11 mcg/mL
Interval 0.1 to 0.13
|
0.11 mcg/mL
Interval 0.09 to 0.14
|
0.19 mcg/mL
Interval 0.17 to 0.23
|
0.22 mcg/mL
Interval 0.19 to 0.26
|
0.54 mcg/mL
Interval 0.46 to 0.64
|
0.45 mcg/mL
Interval 0.35 to 0.57
|
—
|
|
The Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 23F - 1 Month After the Last Dose
|
2.04 mcg/mL
Interval 1.76 to 2.37
|
0.17 mcg/mL
Interval 0.14 to 0.21
|
2.26 mcg/mL
Interval 1.9 to 2.67
|
0.27 mcg/mL
Interval 0.22 to 0.34
|
2.80 mcg/mL
Interval 2.33 to 3.36
|
0.44 mcg/mL
Interval 0.34 to 0.56
|
—
|
SECONDARY outcome
Timeframe: Cohort 2, 3, 4: Before Vaccination and 1 Month After the Last DosePopulation: Evaluable analysis set included all participants evaluable for the study at randomization; received all study vaccinations for Cohort 2-4; had blood draw for assay testing within 27-56 days after visit 3 for Cohort 2, visit 2 for Cohort 3 and visit 1 for Cohort 4 and the sample from this blood draw provided at least 1 valid and determinate assay result; received no prohibited vaccine; had no major protocol violation.
Serotype-specific OPA titers to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in a randomly selected subset of approximately 50 participants receiving 13vPnC and approximately 25 participants receiving Hib vaccine from the blood samples taken before vaccination and 1 month after the last 13vPnC vaccination in each of the 3 cohorts.
Outcome measures
| Measure |
Cohort 1_Infant Series
n=87 Participants
Participants vaccinated 3 infant series doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 42 to 56 days of age; Vaccination 2 (Visit 2): 42 to 70 days after Visit 1; Vaccination 3: 42 to 70 days after Visit 2.
|
Cohort 2_13vPnC
n=34 Participants
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 3_13vPnC
n=78 Participants
Participants vaccinated 2 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): \>=1 to \<2 years of age; Vaccination 2: at least 56 days after Visit 1.
|
Cohort 4_vPnC
n=42 Participants
Participants vaccinated 1 dose of 13vPnC (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 2_13vPnC_Vaccination 3
n=71 Participants
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 4_Hib Vaccine
n=36 Participants
Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 4_Hib Vaccine
Proportion of participants achieving pneumococcal serotype-specific IgG concentration \>=0.35 µg/mL for 1 month after the last dose of Hib vaccine in Cohort 4.
|
|---|---|---|---|---|---|---|---|
|
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 3 - Before Vaccination
|
5.8 GMT
Interval 5.0 to 6.7
|
6.7 GMT
Interval 4.5 to 10.0
|
11.9 GMT
Interval 8.6 to 16.5
|
11.3 GMT
Interval 6.9 to 18.5
|
27.1 GMT
Interval 19.2 to 38.4
|
40.0 GMT
Interval 22.7 to 70.7
|
—
|
|
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 3 - 1 Month After the Last Dose
|
249.0 GMT
Interval 205.7 to 301.5
|
7.4 GMT
Interval 4.9 to 11.3
|
332.3 GMT
Interval 273.3 to 404.1
|
13.4 GMT
Interval 7.7 to 23.4
|
244.8 GMT
Interval 192.0 to 312.1
|
28.4 GMT
Interval 16.2 to 49.7
|
—
|
|
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 4 - Before Vaccination
|
5.5 GMT
Interval 4.3 to 6.9
|
5.0 GMT
Interval 3.6 to 6.9
|
6.3 GMT
Interval 4.8 to 8.3
|
9.5 GMT
Interval 5.6 to 16.2
|
23.4 GMT
Interval 13.8 to 39.7
|
15.9 GMT
Interval 8.4 to 30.1
|
—
|
|
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 4 - 1 Month After the Last Dose
|
2172.2 GMT
Interval 1740.7 to 2710.7
|
10.3 GMT
Interval 5.2 to 20.3
|
2682.8 GMT
Interval 2210.4 to 3256.2
|
10.6 GMT
Interval 5.7 to 19.6
|
4236.3 GMT
Interval 3489.6 to 5142.8
|
19.2 GMT
Interval 10.0 to 36.6
|
—
|
|
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 23F - 1 Month After the Last Dose
|
5640.0 GMT
Interval 3950.5 to 8859.4
|
20.2 GMT
Interval 8.5 to 47.7
|
6693.6 GMT
Interval 4464.2 to 10036.4
|
19.4 GMT
Interval 8.8 to 42.8
|
4234.7 GMT
Interval 2916.1 to 6149.5
|
97.2 GMT
Interval 40.8 to 231.2
|
—
|
|
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 1 - Before Vaccination
|
4.1 GMT
Interval 3.9 to 4.4
|
4.2 GMT
Interval 3.8 to 4.6
|
4.0 GMT
Interval 4.0 to 4.0
|
4.2 GMT
Interval 3.8 to 4.7
|
4.6 GMT
Interval 4.2 to 5.0
|
5.5 GMT
Interval 4.5 to 6.7
|
—
|
|
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 7F - 1 Month After the Last Dose
|
10234.6 GMT
Interval 8612.2 to 12162.8
|
94.0 GMT
Interval 37.2 to 237.3
|
14963.5 GMT
Interval 12367.6 to 18104.4
|
707.1 GMT
Interval 361.9 to 1381.6
|
17107.3 GMT
Interval 13842.7 to 21141.8
|
1090.7 GMT
Interval 696.2 to 1708.8
|
—
|
|
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 1 - 1 Month After the Last Dose
|
142.7 GMT
Interval 103.4 to 196.9
|
4.9 GMT
Interval 3.6 to 6.8
|
93.3 GMT
Interval 70.1 to 124.1
|
4.8 GMT
Interval 3.8 to 6.0
|
40.9 GMT
Interval 31.3 to 53.4
|
4.4 GMT
Interval 3.8 to 5.1
|
—
|
|
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 5 - Before Vaccination
|
4.3 GMT
Interval 3.8 to 4.9
|
4.0 GMT
Interval 4.0 to 4.0
|
4.2 GMT
Interval 3.9 to 4.4
|
4.1 GMT
Interval 3.9 to 4.4
|
4.7 GMT
Interval 4.1 to 5.3
|
4.2 GMT
Interval 3.9 to 4.6
|
—
|
|
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 5 - 1 Month After the Last Dose
|
286.3 GMT
Interval 214.5 to 382.0
|
6.2 GMT
Interval 4.0 to 9.7
|
164.5 GMT
Interval 131.5 to 205.7
|
5.1 GMT
Interval 3.6 to 7.2
|
79.3 GMT
Interval 57.7 to 109.0
|
4.8 GMT
Interval 4.0 to 5.8
|
—
|
|
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 6A - Before Vaccination
|
5.0 GMT
Interval 4.1 to 6.3
|
4.0 GMT
Interval 4.0 to 4.0
|
6.9 GMT
Interval 4.9 to 9.8
|
8.2 GMT
Interval 4.7 to 14.3
|
45.5 GMT
Interval 26.5 to 78.0
|
137.4 GMT
Interval 63.3 to 297.9
|
—
|
|
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 6A - 1 Month After the Last Dose
|
6042.7 GMT
Interval 4830.2 to 7559.6
|
5.9 GMT
Interval 4.0 to 8.8
|
7661.8 GMT
Interval 6116.0 to 9598.4
|
17.8 GMT
Interval 8.1 to 39.1
|
5849.3 GMT
Interval 4364.0 to 7840.2
|
101.8 GMT
Interval 45.7 to 226.8
|
—
|
|
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 6B - Before Vaccination
|
5.1 GMT
Interval 4.1 to 6.4
|
4.0 GMT
Interval 4.0 to 4.0
|
8.2 GMT
Interval 5.5 to 12.2
|
9.7 GMT
Interval 5.6 to 16.8
|
53.6 GMT
Interval 30.4 to 94.5
|
94.9 GMT
Interval 43.0 to 209.3
|
—
|
|
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 6B - 1 Month After the Last Dose
|
2181.6 GMT
Interval 1350.1 to 3525.2
|
5.7 GMT
Interval 3.8 to 8.6
|
4986.3 GMT
Interval 3717.6 to 6687.9
|
20.2 GMT
Interval 9.3 to 43.8
|
3775.2 GMT
Interval 2825.1 to 5044.9
|
117.7 GMT
Interval 51.9 to 267.1
|
—
|
|
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 7F - Before Vaccination
|
63.0 GMT
Interval 35.8 to 111.0
|
29.6 GMT
Interval 12.4 to 70.4
|
195.8 GMT
Interval 114.5 to 334.9
|
432.7 GMT
Interval 213.8 to 875.8
|
1155.2 GMT
Interval 852.6 to 1565.2
|
892.7 GMT
Interval 515.3 to 1546.5
|
—
|
|
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 9V - Before Vaccination
|
9.3 GMT
Interval 6.3 to 13.8
|
11.3 GMT
Interval 5.9 to 21.5
|
59.5 GMT
Interval 34.1 to 103.7
|
74.5 GMT
Interval 31.0 to 179.0
|
458.9 GMT
Interval 280.9 to 749.8
|
850.2 GMT
Interval 469.4 to 1539.9
|
—
|
|
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 9V - 1 Month After the Last Dose
|
4154.1 GMT
Interval 3358.6 to 5138.0
|
20.6 GMT
Interval 9.1 to 46.8
|
7220.1 GMT
Interval 5620.9 to 9274.2
|
154.3 GMT
Interval 69.9 to 340.9
|
10533.5 GMT
Interval 7811.9 to 14203.4
|
795.1 GMT
Interval 472.6 to 1337.6
|
—
|
|
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 14 - Before Vaccination
|
9.8 GMT
Interval 6.5 to 14.7
|
12.7 GMT
Interval 6.2 to 26.3
|
30.0 GMT
Interval 16.1 to 56.1
|
19.1 GMT
Interval 8.5 to 43.0
|
132.6 GMT
Interval 64.8 to 271.5
|
210.6 GMT
Interval 87.7 to 505.5
|
—
|
|
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 14 - 1 Month After the Last Dose
|
4108.0 GMT
Interval 3342.6 to 5048.8
|
26.6 GMT
Interval 11.4 to 62.3
|
6885.4 GMT
Interval 5642.6 to 8402.0
|
39.0 GMT
Interval 16.3 to 93.2
|
7504.5 GMT
Interval 5718.2 to 9848.9
|
294.9 GMT
Interval 126.5 to 687.1
|
—
|
|
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 18C - Before Vaccination
|
4.3 GMT
Interval 3.8 to 4.9
|
4.4 GMT
Interval 3.8 to 5.1
|
6.1 GMT
Interval 5.0 to 7.4
|
6.3 GMT
Interval 4.4 to 8.9
|
12.7 GMT
Interval 8.4 to 19.1
|
20.3 GMT
Interval 10.0 to 41.3
|
—
|
|
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 18C - 1 Month After the Last Dose
|
1486.6 GMT
Interval 1124.6 to 1965.2
|
6.5 GMT
Interval 4.1 to 10.3
|
1890.4 GMT
Interval 1429.0 to 2500.6
|
7.9 GMT
Interval 4.8 to 13.1
|
2111.9 GMT
Interval 1630.6 to 2735.2
|
24.6 GMT
Interval 12.1 to 50.1
|
—
|
|
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 19A - Before Vaccination
|
5.3 GMT
Interval 4.5 to 6.3
|
5.8 GMT
Interval 4.1 to 8.1
|
11.1 GMT
Interval 7.8 to 15.8
|
13.8 GMT
Interval 7.8 to 24.3
|
60.3 GMT
Interval 37.6 to 96.7
|
52.0 GMT
Interval 24.2 to 111.6
|
—
|
|
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 19A - 1 Month After the Last Dose
|
2611.3 GMT
Interval 2071.6 to 3291.6
|
6.4 GMT
Interval 4.6 to 8.9
|
3560.0 GMT
Interval 2867.8 to 4419.1
|
15.5 GMT
Interval 8.6 to 28.2
|
3055.1 GMT
Interval 2154.1 to 4333.1
|
54.3 GMT
Interval 27.6 to 107.1
|
—
|
|
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 19F - Before Vaccination
|
4.3 GMT
Interval 3.9 to 4.8
|
4.6 GMT
Interval 3.7 to 5.7
|
6.2 GMT
Interval 4.9 to 7.8
|
6.1 GMT
Interval 4.5 to 8.3
|
24.7 GMT
Interval 15.7 to 38.9
|
38.5 GMT
Interval 18.1 to 81.8
|
—
|
|
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 19F - 1 Month After the Last Dose
|
1158.4 GMT
Interval 937.0 to 1432.1
|
5.9 GMT
Interval 4.1 to 8.6
|
1854.0 GMT
Interval 1520.3 to 2260.8
|
9.5 GMT
Interval 5.6 to 16.2
|
1629.7 GMT
Interval 1292.9 to 2054.2
|
41.1 GMT
Interval 19.4 to 86.8
|
—
|
|
The Serotype-specific OPA GMT for Each of the Pneumococcal Serotypes in Cohorts 2, 3, 4 Vaccinated With 13 vPnC Compared to Cohorts 2, 3 and 4 Vaccinated With Hib Vaccine.
Serotype 23F - Before Vaccination
|
5.1 GMT
Interval 4.1 to 6.3
|
4.7 GMT
Interval 3.4 to 6.4
|
15.0 GMT
Interval 8.8 to 25.6
|
11.1 GMT
Interval 5.6 to 22.0
|
106.0 GMT
Interval 59.5 to 188.9
|
70.5 GMT
Interval 29.5 to 168.3
|
—
|
SECONDARY outcome
Timeframe: Cohort 1: 1 month after the 3rd dose of 13vPnC. Cohorts 2, 3, 4: 1 month after the last dose of 13vPnC and Hib Vaccine.Population: Evaluable analysis set included all participants evaluable for the study at randomization; received all study vaccinations for Cohort 2-4, received all 3 infant series doses for Cohort 1; had blood draw for assay testing within 27-56 days after 3rd vaccination for Cohort 1, visit 3 for Cohort 2, visit 2 for Cohort 3 and visit 1 for Cohort 4 and the sample from this blood draw provided at least 1 valid and determinate assay result; received no prohibited vaccine; had no major protocol violation.
Serotype-specific IgG concentrations to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all participants from the blood samples taken 1 month after the infant series in Cohort 1 and the last dose of vaccination (13vPnC or Hib vaccine) in Cohorts 2, 3, 4.
Outcome measures
| Measure |
Cohort 1_Infant Series
n=72 Participants
Participants vaccinated 3 infant series doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 42 to 56 days of age; Vaccination 2 (Visit 2): 42 to 70 days after Visit 1; Vaccination 3: 42 to 70 days after Visit 2.
|
Cohort 2_13vPnC
n=176 Participants
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 3_13vPnC
n=72 Participants
Participants vaccinated 2 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): \>=1 to \<2 years of age; Vaccination 2: at least 56 days after Visit 1.
|
Cohort 4_vPnC
n=127 Participants
Participants vaccinated 1 dose of 13vPnC (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 2_13vPnC_Vaccination 3
n=77 Participants
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 4_Hib Vaccine
n=131 Participants
Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 4_Hib Vaccine
n=67 Participants
Proportion of participants achieving pneumococcal serotype-specific IgG concentration \>=0.35 µg/mL for 1 month after the last dose of Hib vaccine in Cohort 4.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype 1
|
100.0 Percentage of Participants
Interval 95.0 to 100.0
|
99.4 Percentage of Participants
Interval 96.9 to 100.0
|
4.2 Percentage of Participants
Interval 0.9 to 11.7
|
97.6 Percentage of Participants
Interval 93.3 to 99.5
|
10.4 Percentage of Participants
Interval 4.6 to 19.4
|
99.2 Percentage of Participants
Interval 95.8 to 100.0
|
23.9 Percentage of Participants
Interval 14.3 to 35.9
|
|
Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype 3
|
83.3 Percentage of Participants
Interval 72.7 to 91.1
|
97.7 Percentage of Participants
Interval 94.3 to 99.4
|
4.2 Percentage of Participants
Interval 0.9 to 11.7
|
94.5 Percentage of Participants
Interval 89.0 to 97.8
|
11.7 Percentage of Participants
Interval 5.5 to 21.0
|
98.5 Percentage of Participants
Interval 94.6 to 99.8
|
19.4 Percentage of Participants
Interval 10.8 to 30.9
|
|
Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype 4
|
100.0 Percentage of Participants
Interval 95.0 to 100.0
|
99.4 Percentage of Participants
Interval 96.9 to 100.0
|
5.6 Percentage of Participants
Interval 1.5 to 13.6
|
97.6 Percentage of Participants
Interval 93.3 to 99.5
|
6.5 Percentage of Participants
Interval 2.1 to 14.5
|
99.2 Percentage of Participants
Interval 95.8 to 100.0
|
4.5 Percentage of Participants
Interval 0.9 to 12.5
|
|
Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype 5
|
100.0 Percentage of Participants
Interval 95.0 to 100.0
|
100.0 Percentage of Participants
Interval 97.9 to 100.0
|
69.4 Percentage of Participants
Interval 57.5 to 79.8
|
100.0 Percentage of Participants
Interval 97.1 to 100.0
|
85.7 Percentage of Participants
Interval 75.9 to 92.6
|
99.2 Percentage of Participants
Interval 95.8 to 100.0
|
88.1 Percentage of Participants
Interval 77.8 to 94.7
|
|
Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype 6A
|
100.0 Percentage of Participants
Interval 95.0 to 100.0
|
97.7 Percentage of Participants
Interval 94.3 to 99.4
|
33.3 Percentage of Participants
Interval 22.7 to 45.4
|
97.6 Percentage of Participants
Interval 93.3 to 99.5
|
56.6 Percentage of Participants
Interval 44.7 to 67.9
|
100.0 Percentage of Participants
Interval 97.2 to 100.0
|
86.6 Percentage of Participants
Interval 76.0 to 93.7
|
|
Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype 6B
|
100.0 Percentage of Participants
Interval 95.0 to 100.0
|
96.0 Percentage of Participants
Interval 92.0 to 98.4
|
23.6 Percentage of Participants
Interval 14.4 to 35.1
|
97.6 Percentage of Participants
Interval 93.3 to 99.5
|
50.6 Percentage of Participants
Interval 39.0 to 62.2
|
99.2 Percentage of Participants
Interval 95.8 to 100.0
|
77.6 Percentage of Participants
Interval 65.8 to 86.9
|
|
Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype 7F
|
100.0 Percentage of Participants
Interval 95.0 to 100.0
|
99.4 Percentage of Participants
Interval 96.9 to 100.0
|
4.2 Percentage of Participants
Interval 0.9 to 11.9
|
98.4 Percentage of Participants
Interval 94.4 to 99.8
|
21.1 Percentage of Participants
Interval 12.5 to 31.9
|
99.2 Percentage of Participants
Interval 95.8 to 100.0
|
37.3 Percentage of Participants
Interval 25.8 to 50.0
|
|
Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype 9V
|
100.0 Percentage of Participants
Interval 95.0 to 100.0
|
98.3 Percentage of Participants
Interval 95.1 to 99.6
|
31.9 Percentage of Participants
Interval 21.4 to 44.0
|
99.2 Percentage of Participants
Interval 95.7 to 100.0
|
40.8 Percentage of Participants
Interval 29.6 to 52.7
|
100.0 Percentage of Participants
Interval 97.2 to 100.0
|
59.7 Percentage of Participants
Interval 47.0 to 71.5
|
|
Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype 14
|
97.2 Percentage of Participants
Interval 90.3 to 99.7
|
99.4 Percentage of Participants
Interval 96.9 to 100.0
|
6.9 Percentage of Participants
Interval 2.3 to 15.5
|
98.4 Percentage of Participants
Interval 94.4 to 99.8
|
22.1 Percentage of Participants
Interval 13.4 to 33.0
|
100.0 Percentage of Participants
Interval 97.2 to 100.0
|
41.8 Percentage of Participants
Interval 29.8 to 54.5
|
|
Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype 18C
|
100.0 Percentage of Participants
Interval 95.0 to 100.0
|
97.7 Percentage of Participants
Interval 94.3 to 99.4
|
5.6 Percentage of Participants
Interval 1.5 to 13.6
|
98.4 Percentage of Participants
Interval 94.4 to 99.8
|
15.6 Percentage of Participants
Interval 8.3 to 25.6
|
100.0 Percentage of Participants
Interval 97.2 to 100.0
|
40.9 Percentage of Participants
Interval 29.0 to 53.7
|
|
Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype 19A
|
100.0 Percentage of Participants
Interval 95.0 to 100.0
|
100.0 Percentage of Participants
Interval 97.9 to 100.0
|
63.9 Percentage of Participants
Interval 51.7 to 74.9
|
100.0 Percentage of Participants
Interval 97.1 to 100.0
|
90.9 Percentage of Participants
Interval 82.2 to 96.3
|
100.0 Percentage of Participants
Interval 97.2 to 100.0
|
94.0 Percentage of Participants
Interval 85.4 to 98.3
|
|
Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype 19F
|
98.6 Percentage of Participants
Interval 92.5 to 100.0
|
98.9 Percentage of Participants
Interval 96.0 to 99.9
|
29.2 Percentage of Participants
Interval 19.0 to 41.1
|
97.6 Percentage of Participants
Interval 93.3 to 99.5
|
44.2 Percentage of Participants
Interval 32.8 to 55.9
|
100.0 Percentage of Participants
Interval 97.2 to 100.0
|
70.1 Percentage of Participants
Interval 57.7 to 80.7
|
|
Percentage of Participants Achieving Pneumococcal Serotype-specific IgG Concentration ≥0.35 mcg/mL for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype 23F
|
95.8 Percentage of Participants
Interval 88.3 to 99.1
|
95.5 Percentage of Participants
Interval 91.2 to 98.0
|
14.1 Percentage of Participants
Interval 7.0 to 24.4
|
97.6 Percentage of Participants
Interval 93.3 to 99.5
|
26.0 Percentage of Participants
Interval 16.6 to 37.2
|
96.9 Percentage of Participants
Interval 92.4 to 99.2
|
52.2 Percentage of Participants
Interval 39.7 to 64.6
|
SECONDARY outcome
Timeframe: Cohort 1: 1 month after the 3rd dose of 13vPnC. Cohorts 2, 3, 4: 1 month after the last dose of 13vPnC and Hib Vaccine.Population: Evaluable analysis set included all participants evaluable for the study at randomization; received all study vaccinations for Cohort 2-4, received all 3 infant series doses for Cohort 1; had blood draw for assay testing within 27-56 days after 3rd vaccination for Cohort 1, visit 3 for Cohort 2, visit 2 for Cohort 3 and visit 1 for Cohort 4 and the sample from this blood draw provided at least 1 valid and determinate assay result; received no prohibited vaccine; had no major protocol violation.
Serotype-specific OPA titers to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in a randomly selected subset of about 50 participants receiving 13vPnC from the blood samples taken 1 month after the infant series in Cohort 1 and the last vaccination (13vPnC or Hib vaccine) in each of the 3 cohorts.
Outcome measures
| Measure |
Cohort 1_Infant Series
n=37 Participants
Participants vaccinated 3 infant series doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 42 to 56 days of age; Vaccination 2 (Visit 2): 42 to 70 days after Visit 1; Vaccination 3: 42 to 70 days after Visit 2.
|
Cohort 2_13vPnC
n=87 Participants
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 3_13vPnC
n=34 Participants
Participants vaccinated 2 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): \>=1 to \<2 years of age; Vaccination 2: at least 56 days after Visit 1.
|
Cohort 4_vPnC
n=78 Participants
Participants vaccinated 1 dose of 13vPnC (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 2_13vPnC_Vaccination 3
n=42 Participants
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 4_Hib Vaccine
n=71 Participants
Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 4_Hib Vaccine
n=36 Participants
Proportion of participants achieving pneumococcal serotype-specific IgG concentration \>=0.35 µg/mL for 1 month after the last dose of Hib vaccine in Cohort 4.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype 9V
|
100.0 Percentage of Participants
Interval 90.5 to 100.0
|
100.0 Percentage of Participants
Interval 95.8 to 100.0
|
41.2 Percentage of Participants
Interval 24.6 to 59.3
|
100.0 Percentage of Participants
Interval 95.4 to 100.0
|
76.2 Percentage of Participants
Interval 60.5 to 87.9
|
100.0 Percentage of Participants
Interval 94.9 to 100.0
|
97.2 Percentage of Participants
Interval 85.5 to 99.9
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype 19F
|
97.3 Percentage of Participants
Interval 85.8 to 99.9
|
100.0 Percentage of Participants
Interval 95.8 to 100.0
|
17.6 Percentage of Participants
Interval 6.8 to 34.5
|
100.0 Percentage of Participants
Interval 95.4 to 100.0
|
26.2 Percentage of Participants
Interval 13.9 to 42.0
|
100.0 Percentage of Participants
Interval 94.9 to 100.0
|
63.9 Percentage of Participants
Interval 46.2 to 79.2
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype 1
|
100.0 Percentage of Participants
Interval 90.5 to 100.0
|
96.6 Percentage of Participants
Interval 90.3 to 99.3
|
5.9 Percentage of Participants
Interval 0.7 to 19.7
|
96.2 Percentage of Participants
Interval 89.2 to 99.2
|
7.1 Percentage of Participants
Interval 1.5 to 19.5
|
95.8 Percentage of Participants
Interval 88.1 to 99.1
|
5.6 Percentage of Participants
Interval 0.7 to 18.7
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype 3
|
100.0 Percentage of Participants
Interval 90.5 to 100.0
|
100.0 Percentage of Participants
Interval 95.8 to 100.0
|
29.4 Percentage of Participants
Interval 15.1 to 47.5
|
100.0 Percentage of Participants
Interval 95.4 to 100.0
|
38.1 Percentage of Participants
Interval 23.6 to 54.4
|
100.0 Percentage of Participants
Interval 94.9 to 100.0
|
80.6 Percentage of Participants
Interval 64.0 to 91.8
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype 4
|
100.0 Percentage of Participants
Interval 90.5 to 100.0
|
100.0 Percentage of Participants
Interval 95.8 to 100.0
|
23.5 Percentage of Participants
Interval 10.7 to 41.2
|
100.0 Percentage of Participants
Interval 95.4 to 100.0
|
23.8 Percentage of Participants
Interval 12.1 to 39.5
|
100.0 Percentage of Participants
Interval 94.9 to 100.0
|
55.6 Percentage of Participants
Interval 38.1 to 72.1
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype 5
|
100.0 Percentage of Participants
Interval 90.5 to 100.0
|
100.0 Percentage of Participants
Interval 95.8 to 100.0
|
14.7 Percentage of Participants
Interval 5.0 to 31.1
|
100.0 Percentage of Participants
Interval 95.4 to 100.0
|
4.8 Percentage of Participants
Interval 0.6 to 16.2
|
98.6 Percentage of Participants
Interval 92.4 to 100.0
|
11.1 Percentage of Participants
Interval 3.1 to 26.1
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype 6A
|
100.0 Percentage of Participants
Interval 90.5 to 100.0
|
100.0 Percentage of Participants
Interval 95.8 to 100.0
|
14.7 Percentage of Participants
Interval 5.0 to 31.1
|
100.0 Percentage of Participants
Interval 95.4 to 100.0
|
31.0 Percentage of Participants
Interval 17.6 to 47.1
|
100.0 Percentage of Participants
Interval 94.9 to 100.0
|
80.6 Percentage of Participants
Interval 64.0 to 91.8
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype 6B
|
100.0 Percentage of Participants
Interval 90.5 to 100.0
|
94.3 Percentage of Participants
Interval 87.1 to 98.1
|
11.8 Percentage of Participants
Interval 3.3 to 27.5
|
98.7 Percentage of Participants
Interval 93.1 to 100.0
|
35.7 Percentage of Participants
Interval 21.6 to 52.0
|
100.0 Percentage of Participants
Interval 94.9 to 100.0
|
80.6 Percentage of Participants
Interval 64.0 to 91.8
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype 7F
|
100.0 Percentage of Participants
Interval 90.5 to 100.0
|
100.0 Percentage of Participants
Interval 95.8 to 100.0
|
61.8 Percentage of Participants
Interval 43.6 to 77.8
|
100.0 Percentage of Participants
Interval 95.4 to 100.0
|
90.5 Percentage of Participants
Interval 77.4 to 97.3
|
100.0 Percentage of Participants
Interval 94.9 to 100.0
|
100.0 Percentage of Participants
Interval 90.3 to 100.0
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype 14
|
100.0 Percentage of Participants
Interval 90.5 to 100.0
|
100.0 Percentage of Participants
Interval 95.8 to 100.0
|
41.2 Percentage of Participants
Interval 24.6 to 59.3
|
100.0 Percentage of Participants
Interval 95.4 to 100.0
|
45.2 Percentage of Participants
Interval 29.8 to 61.3
|
100.0 Percentage of Participants
Interval 94.9 to 100.0
|
83.3 Percentage of Participants
Interval 67.2 to 93.6
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype 18C
|
100.0 Percentage of Participants
Interval 90.5 to 100.0
|
98.9 Percentage of Participants
Interval 93.8 to 100.0
|
14.7 Percentage of Participants
Interval 5.0 to 31.1
|
98.7 Percentage of Participants
Interval 93.1 to 100.0
|
21.4 Percentage of Participants
Interval 10.3 to 36.8
|
100.0 Percentage of Participants
Interval 94.9 to 100.0
|
52.8 Percentage of Participants
Interval 35.5 to 69.6
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype 19A
|
100.0 Percentage of Participants
Interval 90.5 to 100.0
|
100.0 Percentage of Participants
Interval 95.8 to 100.0
|
26.5 Percentage of Participants
Interval 12.9 to 44.4
|
100.0 Percentage of Participants
Interval 95.4 to 100.0
|
47.6 Percentage of Participants
Interval 32.0 to 63.6
|
100.0 Percentage of Participants
Interval 94.9 to 100.0
|
83.3 Percentage of Participants
Interval 67.2 to 93.6
|
|
Percentage of Participants Achieving Serotype-specific Pneumococcal OPA Titer ≥ Lower Limit of Quantitation (LLOQ) for 1 Month After the Last Vaccination in Cohorts 2,3,4 (13vPnC and Hib Vaccine) and 1 Month After the Infant Series in Cohort 1 (13vPnC).
Serotype 23F
|
97.3 Percentage of Participants
Interval 85.8 to 99.9
|
95.4 Percentage of Participants
Interval 88.6 to 98.7
|
35.3 Percentage of Participants
Interval 19.7 to 53.5
|
96.2 Percentage of Participants
Interval 89.2 to 99.2
|
33.3 Percentage of Participants
Interval 19.6 to 49.5
|
97.2 Percentage of Participants
Interval 90.2 to 99.7
|
72.2 Percentage of Participants
Interval 54.8 to 85.8
|
SECONDARY outcome
Timeframe: From the signing of ICD to 1 month after the 3rd dose of 13vPnC in Cohort 1.Population: The safety population included all participants who received at least 1 dose of the investigational product.
An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.
Outcome measures
| Measure |
Cohort 1_Infant Series
n=125 Participants
Participants vaccinated 3 infant series doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 42 to 56 days of age; Vaccination 2 (Visit 2): 42 to 70 days after Visit 1; Vaccination 3: 42 to 70 days after Visit 2.
|
Cohort 2_13vPnC
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 3_13vPnC
Participants vaccinated 2 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): \>=1 to \<2 years of age; Vaccination 2: at least 56 days after Visit 1.
|
Cohort 4_vPnC
Participants vaccinated 1 dose of 13vPnC (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 2_13vPnC_Vaccination 3
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 4_Hib Vaccine
Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 4_Hib Vaccine
Proportion of participants achieving pneumococcal serotype-specific IgG concentration \>=0.35 µg/mL for 1 month after the last dose of Hib vaccine in Cohort 4.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With AE From the Signing of the ICD to 1 Month After the Infant Series in Cohort 1
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From 1 month after Vaccination 3 to Vaccination 4.Population: The safety population were participants who received at least 1 dose of the investigational product.
Number of Participants With NDCMCs from 1 month after vaccination 3 to vaccination 4 in Cohort 1. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
Outcome measures
| Measure |
Cohort 1_Infant Series
n=125 Participants
Participants vaccinated 3 infant series doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 42 to 56 days of age; Vaccination 2 (Visit 2): 42 to 70 days after Visit 1; Vaccination 3: 42 to 70 days after Visit 2.
|
Cohort 2_13vPnC
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 3_13vPnC
Participants vaccinated 2 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): \>=1 to \<2 years of age; Vaccination 2: at least 56 days after Visit 1.
|
Cohort 4_vPnC
Participants vaccinated 1 dose of 13vPnC (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 2_13vPnC_Vaccination 3
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 4_Hib Vaccine
Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 4_Hib Vaccine
Proportion of participants achieving pneumococcal serotype-specific IgG concentration \>=0.35 µg/mL for 1 month after the last dose of Hib vaccine in Cohort 4.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With NDCMCs From 1 Month After Vaccination 3 to Vaccination 4 in Cohort 1
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Vaccination 4 to 1 month after Vaccination 4 in Cohort 1.Population: The safety population were participants who received at least 1 dose of the investigational product.
Number of Participants With AEs from vaccination 4 to 1 month after vaccination 4 in Cohort 1. An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.
Outcome measures
| Measure |
Cohort 1_Infant Series
n=90 Participants
Participants vaccinated 3 infant series doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 42 to 56 days of age; Vaccination 2 (Visit 2): 42 to 70 days after Visit 1; Vaccination 3: 42 to 70 days after Visit 2.
|
Cohort 2_13vPnC
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 3_13vPnC
Participants vaccinated 2 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): \>=1 to \<2 years of age; Vaccination 2: at least 56 days after Visit 1.
|
Cohort 4_vPnC
Participants vaccinated 1 dose of 13vPnC (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 2_13vPnC_Vaccination 3
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 4_Hib Vaccine
Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 4_Hib Vaccine
Proportion of participants achieving pneumococcal serotype-specific IgG concentration \>=0.35 µg/mL for 1 month after the last dose of Hib vaccine in Cohort 4.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With AE From Toddler Dose Until 1 Month After the Toddler Dose in Cohort 1
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From 1 month to 6 months (5 months) after Vaccination 4 in Cohort 1.Population: The safety population were participants who received at least 1 dose of the investigational product.
Number of Participants With NDCMCs from 1 month after vaccination 4 to 6 months after vaccination 4 in Cohort 1. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
Outcome measures
| Measure |
Cohort 1_Infant Series
n=90 Participants
Participants vaccinated 3 infant series doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 42 to 56 days of age; Vaccination 2 (Visit 2): 42 to 70 days after Visit 1; Vaccination 3: 42 to 70 days after Visit 2.
|
Cohort 2_13vPnC
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 3_13vPnC
Participants vaccinated 2 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): \>=1 to \<2 years of age; Vaccination 2: at least 56 days after Visit 1.
|
Cohort 4_vPnC
Participants vaccinated 1 dose of 13vPnC (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 2_13vPnC_Vaccination 3
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 4_Hib Vaccine
Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 4_Hib Vaccine
Proportion of participants achieving pneumococcal serotype-specific IgG concentration \>=0.35 µg/mL for 1 month after the last dose of Hib vaccine in Cohort 4.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With NDCMCs From 1 Month to 6 Months After the Toddler Dose in Cohort 1
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the Signing of the ICD to 6 Months After the Vaccination 4.Population: The safety population were participants who received at least 1 dose of the investigational product.
Number of Participants With SAEs from the signing of the ICD to 6 months after vaccination 4. An SAE was any untoward medical occurrence at any dose that resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or considered to be an important medical event.
Outcome measures
| Measure |
Cohort 1_Infant Series
n=125 Participants
Participants vaccinated 3 infant series doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 42 to 56 days of age; Vaccination 2 (Visit 2): 42 to 70 days after Visit 1; Vaccination 3: 42 to 70 days after Visit 2.
|
Cohort 2_13vPnC
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 3_13vPnC
Participants vaccinated 2 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): \>=1 to \<2 years of age; Vaccination 2: at least 56 days after Visit 1.
|
Cohort 4_vPnC
Participants vaccinated 1 dose of 13vPnC (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 2_13vPnC_Vaccination 3
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 4_Hib Vaccine
Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 4_Hib Vaccine
Proportion of participants achieving pneumococcal serotype-specific IgG concentration \>=0.35 µg/mL for 1 month after the last dose of Hib vaccine in Cohort 4.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With SAEs From the Signing of the ICD to 6 Months After the Toddler Dose in Cohort 1
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 1 (infant series): 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1Population: Evaluable analysis set was analyzed. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at specific rows.
Serotype-specific IgG concentrations to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all participants from the blood samples taken after last vaccination in Cohort 1. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Outcome measures
| Measure |
Cohort 1_Infant Series
n=75 Participants
Participants vaccinated 3 infant series doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 42 to 56 days of age; Vaccination 2 (Visit 2): 42 to 70 days after Visit 1; Vaccination 3: 42 to 70 days after Visit 2.
|
Cohort 2_13vPnC
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 3_13vPnC
Participants vaccinated 2 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): \>=1 to \<2 years of age; Vaccination 2: at least 56 days after Visit 1.
|
Cohort 4_vPnC
Participants vaccinated 1 dose of 13vPnC (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 2_13vPnC_Vaccination 3
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 4_Hib Vaccine
Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 4_Hib Vaccine
Proportion of participants achieving pneumococcal serotype-specific IgG concentration \>=0.35 µg/mL for 1 month after the last dose of Hib vaccine in Cohort 4.
|
|---|---|---|---|---|---|---|---|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 9V: 48 Months After Last Vaccination in Cohort 1
|
0.95 Microgram/milliliter
Interval 0.78 to 1.16
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 18C: 12 Months After Last Vaccination in Cohort 1
|
1.24 Microgram/milliliter
Interval 1.07 to 1.43
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 18C: 24 Months After Last Vaccination in Cohort 1
|
0.72 Microgram/milliliter
Interval 0.58 to 0.89
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 19A: 24 Months After Last Vaccination in Cohort 1
|
3.52 Microgram/milliliter
Interval 2.68 to 4.63
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 1: 12 Months After Last Vaccination in Cohort 1
|
1.35 Microgram/milliliter
Interval 1.1 to 1.65
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 1: 24 Months After Last Vaccination in Cohort 1
|
0.88 Microgram/milliliter
Interval 0.75 to 1.03
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 1: 36 Months After Last Vaccination in Cohort 1
|
0.77 Microgram/milliliter
Interval 0.67 to 0.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 1: 48 Months After Last Vaccination in Cohort 1
|
0.79 Microgram/milliliter
Interval 0.69 to 0.91
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 3: 12 Months After Last Vaccination in Cohort 1
|
0.27 Microgram/milliliter
Interval 0.24 to 0.31
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 3: 24 Months After Last Vaccination in Cohort 1
|
0.22 Microgram/milliliter
Interval 0.17 to 0.28
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 3: 36 Months After Last Vaccination in Cohort 1
|
0.18 Microgram/milliliter
Interval 0.14 to 0.21
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 3: 48 Months After Last Vaccination in Cohort 1
|
0.19 Microgram/milliliter
Interval 0.13 to 0.26
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 4: 12 Months After Last Vaccination in Cohort 1
|
1.10 Microgram/milliliter
Interval 0.9 to 1.35
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 4: 24 Months After Last Vaccination in Cohort 1
|
0.54 Microgram/milliliter
Interval 0.41 to 0.71
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 4: 36 Months After Last Vaccination in Cohort 1
|
0.58 Microgram/milliliter
Interval 0.45 to 0.75
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 4: 48 Months After Last Vaccination in Cohort 1
|
0.32 Microgram/milliliter
Interval 0.23 to 0.44
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 5: 12 Months After Last Vaccination in Cohort 1
|
1.56 Microgram/milliliter
Interval 1.35 to 1.81
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 5: 24 Months After Last Vaccination in Cohort 1
|
1.03 Microgram/milliliter
Interval 0.91 to 1.17
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 5: 36 Months After Last Vaccination in Cohort 1
|
1.03 Microgram/milliliter
Interval 0.91 to 1.17
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 5: 48 Months After Last Vaccination in Cohort 1
|
1.19 Microgram/milliliter
Interval 1.05 to 1.34
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 6A: 12 Months After Last Vaccination in Cohort 1
|
2.10 Microgram/milliliter
Interval 1.71 to 2.59
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 6A: 24 Months After Last Vaccination in Cohort 1
|
1.40 Microgram/milliliter
Interval 1.12 to 1.74
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 6A: 36 Months After Last Vaccination in Cohort 1
|
2.79 Microgram/milliliter
Interval 2.04 to 3.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 6A: 48 Months After Last Vaccination in Cohort 1
|
3.06 Microgram/milliliter
Interval 2.3 to 4.06
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 6B: 12 Months After Last Vaccination in Cohort 1
|
2.40 Microgram/milliliter
Interval 1.94 to 2.95
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 6B: 24 Months After Last Vaccination in Cohort 1
|
2.12 Microgram/milliliter
Interval 1.69 to 2.66
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 6B: 36 Months After Last Vaccination in Cohort 1
|
3.29 Microgram/milliliter
Interval 2.57 to 4.21
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 6B: 48 Months After Last Vaccination in Cohort 1
|
3.73 Microgram/milliliter
Interval 2.95 to 4.71
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 7F: 12 Months After Last Vaccination in Cohort 1
|
1.55 Microgram/milliliter
Interval 1.31 to 1.82
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 7F: 24 Months After Last Vaccination in Cohort 1
|
0.77 Microgram/milliliter
Interval 0.67 to 0.88
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 7F: 36 Months After Last Vaccination in Cohort 1
|
0.62 Microgram/milliliter
Interval 0.56 to 0.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 7F: 48 Months After Last Vaccination in Cohort 1
|
0.53 Microgram/milliliter
Interval 0.41 to 0.68
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 9V: 12 Months After Last Vaccination in Cohort 1
|
1.32 Microgram/milliliter
Interval 1.11 to 1.57
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 9V: 24 Months After Last Vaccination in Cohort 1
|
0.88 Microgram/milliliter
Interval 0.74 to 1.04
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 9V: 36 Months After Last Vaccination in Cohort 1
|
0.84 Microgram/milliliter
Interval 0.72 to 0.99
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 14: 12 Months After Last Vaccination in Cohort 1
|
2.77 Microgram/milliliter
Interval 2.3 to 3.34
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 14: 24 Months After Last Vaccination in Cohort 1
|
2.03 Microgram/milliliter
Interval 1.52 to 2.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 14: 36 Months After Last Vaccination in Cohort 1
|
2.49 Microgram/milliliter
Interval 1.76 to 3.51
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 14: 48 Months After Last Vaccination in Cohort 1
|
2.14 Microgram/milliliter
Interval 1.34 to 3.42
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 18C: 36 Months After Last Vaccination in Cohort 1
|
0.67 Microgram/milliliter
Interval 0.54 to 0.81
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 18C: 48 Months After Last Vaccination in Cohort 1
|
0.60 Microgram/milliliter
Interval 0.47 to 0.78
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 19A: 12 Months After Last Vaccination in Cohort 1
|
2.92 Microgram/milliliter
Interval 2.29 to 3.74
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 19A: 36 Months After Last Vaccination in Cohort 1
|
6.39 Microgram/milliliter
Interval 4.79 to 8.51
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 19A: 48 Months After Last Vaccination in Cohort 1
|
7.53 Microgram/milliliter
Interval 6.14 to 9.22
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 19F: 12 Months After Last Vaccination in Cohort 1
|
2.88 Microgram/milliliter
Interval 2.32 to 3.57
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 19F: 24 Months After Last Vaccination in Cohort 1
|
2.73 Microgram/milliliter
Interval 2.01 to 3.72
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 19F: 36 Months After Last Vaccination in Cohort 1
|
4.06 Microgram/milliliter
Interval 2.92 to 5.66
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 19F: 48 Months After Last Vaccination in Cohort 1
|
3.51 Microgram/milliliter
Interval 2.56 to 4.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 23F: 12 Months After Last Vaccination in Cohort 1
|
2.14 Microgram/milliliter
Interval 1.76 to 2.59
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 23F: 24 Months After Last Vaccination in Cohort 1
|
1.72 Microgram/milliliter
Interval 1.44 to 2.04
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 23F: 36 Months After Last Vaccination in Cohort 1
|
1.92 Microgram/milliliter
Interval 1.58 to 2.34
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Serotype-specific IgG GMCs for Each of the Pneumococcal Serotypes in Cohort 1 at 12, 24, 36 and 48 Months After Last Vaccination in Cohort 1 (Infant Series)
Serotype 23F: 48 Months After Last Vaccination in Cohort 1
|
2.15 Microgram/milliliter
Interval 1.75 to 2.63
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 1
Serious events: 9 serious events
Other events: 13 other events
Deaths: 0 deaths
Cohort 2_13vPnC
Serious events: 5 serious events
Other events: 182 other events
Deaths: 0 deaths
Cohort 2_Hib Vaccine
Serious events: 1 serious events
Other events: 74 other events
Deaths: 0 deaths
Cohort 3_13vPnC
Serious events: 2 serious events
Other events: 99 other events
Deaths: 0 deaths
Cohort 3_Hib Vaccine
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Cohort 4_13vPnC
Serious events: 2 serious events
Other events: 66 other events
Deaths: 0 deaths
Cohort 4_Hib Vaccine
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=125 participants at risk
Participants vaccinated 4 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 42 to 56 days of age; Vaccination 2 (Visit 2): 42 to 70 days after Visit 1; Vaccination 3: 42 to 70 days after Visit 2; Vaccination 4: 365 to 455 days of age.
|
Cohort 2_13vPnC
n=236 participants at risk
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 2_Hib Vaccine
n=117 participants at risk
Participants vaccinated 2 doses of Hib Vaccine (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2: at least 28 days after Visit 1;
|
Cohort 3_13vPnC
n=165 participants at risk
Participants vaccinated 2 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): \>=1 to \<2 years of age; Vaccination 2: at least 56 days after Visit 1.
|
Cohort 3_Hib Vaccine
n=83 participants at risk
Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=1 to \<2 years of age;
|
Cohort 4_13vPnC
n=138 participants at risk
Participants vaccinated 1 dose of 13vPnC (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 4_Hib Vaccine
n=68 participants at risk
Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
5.6%
7/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.42%
1/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.61%
1/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.72%
1/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
1.5%
1/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
General disorders
Pyrexia
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
1.3%
3/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.42%
1/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.85%
1/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
1.5%
1/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.80%
1/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Infections and infestations
Otitis media
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.72%
1/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.61%
1/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.61%
1/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.80%
1/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.72%
1/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
Other adverse events
| Measure |
Cohort 1
n=125 participants at risk
Participants vaccinated 4 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 42 to 56 days of age; Vaccination 2 (Visit 2): 42 to 70 days after Visit 1; Vaccination 3: 42 to 70 days after Visit 2; Vaccination 4: 365 to 455 days of age.
|
Cohort 2_13vPnC
n=236 participants at risk
Participants vaccinated 3 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2 (Visit 2): at least 28 days after Visit 1; Vaccination 3: 365 days to \<450 days of age and at least 56 days after Visit 2.
|
Cohort 2_Hib Vaccine
n=117 participants at risk
Participants vaccinated 2 doses of Hib Vaccine (single intramuscular injection): Vaccination 1 (Visit 1): 7 to \<12 months of age; Vaccination 2: at least 28 days after Visit 1;
|
Cohort 3_13vPnC
n=165 participants at risk
Participants vaccinated 2 doses of 13vPnC (single intramuscular injection): Vaccination 1 (Visit 1): \>=1 to \<2 years of age; Vaccination 2: at least 56 days after Visit 1.
|
Cohort 3_Hib Vaccine
n=83 participants at risk
Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=1 to \<2 years of age;
|
Cohort 4_13vPnC
n=138 participants at risk
Participants vaccinated 1 dose of 13vPnC (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
Cohort 4_Hib Vaccine
n=68 participants at risk
Participants vaccinated 1 dose of Hib vaccine (single intramuscular injection): Vaccination 1: \>=2 to \<6 years of age.
|
|---|---|---|---|---|---|---|---|
|
General disorders
Pyrexia
|
2.4%
3/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
13.1%
31/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
11.1%
13/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
4.8%
8/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
1.2%
1/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
2.9%
4/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
3/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
9.3%
22/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
5.1%
6/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
3.0%
5/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
2.2%
3/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
General disorders
Pyrexia (FEVER)
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
51.3%
121/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
31.6%
37/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
33.3%
55/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
19.3%
16/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
14.5%
20/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
23.5%
16/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
General disorders
Swelling (SWELLING)
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
16.1%
38/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
4.3%
5/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
12.7%
21/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
3.6%
3/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
19.6%
27/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
23.5%
16/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
General disorders
Tenderness (TENDERNESS)
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
7.6%
18/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
1.7%
2/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
10.9%
18/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
3.6%
3/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
18.8%
26/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
22.1%
15/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Metabolism and nutrition disorders
Decreased appetite (DECREASED APPETITE)
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
2.5%
6/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
1.7%
2/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
7.9%
13/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
3.6%
3/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
9.3%
22/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
7.7%
9/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.61%
1/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Skin and subcutaneous tissue disorders
Erythema (REDNESS)
|
0.80%
1/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
28.8%
68/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
23.1%
27/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
25.5%
42/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
12.0%
10/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
26.1%
36/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
22.1%
15/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
General disorders
Fatigue (FATIGUE)
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
5.1%
7/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
8.8%
6/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.42%
1/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.85%
1/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.61%
1/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.42%
1/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
1.2%
2/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
1.4%
2/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.42%
1/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.42%
1/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.80%
1/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
2.1%
5/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.85%
1/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.42%
1/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Gastrointestinal disorders
Diarrhoea (DIARRHEA)
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.72%
1/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
1.5%
1/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Gastrointestinal disorders
Vomiting (VOMITING)
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
2.9%
4/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
2.9%
2/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.42%
1/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.42%
1/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.85%
1/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
1.2%
2/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.85%
2/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Infections and infestations
Nasopharyngitis
|
1.6%
2/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.85%
2/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
2.2%
3/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
1.5%
1/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.42%
1/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Infections and infestations
Viral rash
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.42%
1/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
1.7%
2/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Infections and infestations
Hand-foot-and -mouth disease
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
1.8%
3/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.42%
1/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Nervous system disorders
Hypersomnia (INCREASED SLEEP)
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
2.1%
5/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
1.8%
3/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
3.6%
3/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Nervous system disorders
Headache (HEADACHE)
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
1.4%
2/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
2.9%
2/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Psychiatric disorders
Irritability (IRRITABILITY)
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
1.3%
3/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.85%
1/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
4.2%
7/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
2.4%
2/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.61%
1/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.72%
1/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (MUSCLE PAIN)
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
2.9%
4/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
1.5%
1/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (JOINT PAIN)
|
0.00%
0/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
1.4%
2/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.80%
1/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.4%
3/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.2%
4/125 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/236 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/117 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/165 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/83 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/138 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
0.00%
0/68 • AE for Cohort 1: from the signing of the ICD to 1 month after Vaccination 3 and from Vaccination 4 to 1 month after Vaccination 4. AE for Cohorts 2,3,4: from the signing of the ICD to 1 month after the last study vaccination. SAE for Cohort 1,2,3,4: From the signing of the ICD to 6 months after the last study vaccination. See below for detailed vaccination timepoints in each cohort.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. The safety population were participants who received at least 1 dose of the investigational product.
|
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