Trial Outcomes & Findings for Phase 3 Study of 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSIL) in Healthy Infants (NCT NCT03197376)
NCT ID: NCT03197376
Last Updated: 2020-07-14
Results Overview
Serotype-specific concentrations of immunoglobulin G (IgG) antibody measured by ELISA
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2250 participants
Primary outcome timeframe
4 weeks after the third dose
Results posted on
2020-07-14
Participant Flow
Recruitment period: 21 June 2017 to 29 January 2018
Randomization took place only after a subject had satisfied all eligibility criteria. Subjects were randomized in a 2:2:2:3 ratio based on a pre-established randomization scheme.
Participant milestones
| Measure |
Pneumosil Lot 1
10-Valent Pneumococcal Conjugate Vaccine Lot 1
|
Pneumosil Lot 2
10-Valent Pneumococcal Conjugate Vaccine Lot 2
|
Pneumosil Lot 3
10-Valent Pneumococcal Conjugate Vaccine Lot 3
|
Synflorix
Pneumococcal conjugate vaccine (Non-Typeable Haemophilus influenzae (NTHi) protein D, diphtheria or tetanus toxoid conjugates) adsorbed
|
|---|---|---|---|---|
|
Primary and Booster Phase
STARTED
|
502
|
501
|
500
|
747
|
|
Primary and Booster Phase
Vaccinated-Dose 1
|
502
|
501
|
500
|
747
|
|
Primary and Booster Phase
Vaccinated-Dose 2
|
495
|
495
|
491
|
738
|
|
Primary and Booster Phase
Vaccinated-Dose 3
|
492
|
493
|
490
|
731
|
|
Primary and Booster Phase
Primary Reactogenicity Cohort
|
251
|
243
|
257
|
364
|
|
Primary and Booster Phase
Booster Cohort
|
150
|
151
|
150
|
224
|
|
Primary and Booster Phase
Received Booster Vaccine
|
145
|
144
|
139
|
213
|
|
Primary and Booster Phase
COMPLETED
|
487
|
488
|
480
|
722
|
|
Primary and Booster Phase
NOT COMPLETED
|
15
|
13
|
20
|
25
|
|
Immune Persistence Phase
STARTED
|
132
|
133
|
128
|
195
|
|
Immune Persistence Phase
COMPLETED
|
127
|
129
|
123
|
190
|
|
Immune Persistence Phase
NOT COMPLETED
|
5
|
4
|
5
|
5
|
Reasons for withdrawal
| Measure |
Pneumosil Lot 1
10-Valent Pneumococcal Conjugate Vaccine Lot 1
|
Pneumosil Lot 2
10-Valent Pneumococcal Conjugate Vaccine Lot 2
|
Pneumosil Lot 3
10-Valent Pneumococcal Conjugate Vaccine Lot 3
|
Synflorix
Pneumococcal conjugate vaccine (Non-Typeable Haemophilus influenzae (NTHi) protein D, diphtheria or tetanus toxoid conjugates) adsorbed
|
|---|---|---|---|---|
|
Primary and Booster Phase
Adverse Event
|
0
|
0
|
0
|
1
|
|
Primary and Booster Phase
Death
|
1
|
0
|
0
|
2
|
|
Primary and Booster Phase
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Primary and Booster Phase
Physician Decision
|
1
|
0
|
1
|
3
|
|
Primary and Booster Phase
Withdrawal by subject's parents
|
11
|
10
|
14
|
11
|
|
Primary and Booster Phase
Ineligibility criteria
|
1
|
1
|
4
|
2
|
|
Primary and Booster Phase
Not vaccine related
|
1
|
2
|
0
|
6
|
|
Immune Persistence Phase
Lost to Follow-up
|
0
|
0
|
2
|
1
|
|
Immune Persistence Phase
Withdrawal by subject's parents
|
4
|
4
|
2
|
3
|
|
Immune Persistence Phase
Not vaccine related
|
1
|
0
|
1
|
1
|
Baseline Characteristics
Phase 3 Study of 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSIL) in Healthy Infants
Baseline characteristics by cohort
| Measure |
Pneumosil Lot 1
n=502 Participants
Three doses of Pneumosil Lot 1
|
Pneumosil Lot 2
n=501 Participants
Three doses of Pneumosil Lot 2
|
Pneumosil Lot 3
n=500 Participants
Three doses of Pneumosil Lot 3
|
Synflorix
n=747 Participants
Three doses of Synflorix
|
Total
n=2250 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47.0 Days
STANDARD_DEVIATION 3.78 • n=5 Participants
|
47.1 Days
STANDARD_DEVIATION 4.10 • n=7 Participants
|
47.3 Days
STANDARD_DEVIATION 4.03 • n=5 Participants
|
47.1 Days
STANDARD_DEVIATION 4.05 • n=4 Participants
|
47.2 Days
STANDARD_DEVIATION 4.01 • n=21 Participants
|
|
Sex: Female, Male
Female
|
252 Participants
n=5 Participants
|
241 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
347 Participants
n=4 Participants
|
1085 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
250 Participants
n=5 Participants
|
260 Participants
n=7 Participants
|
255 Participants
n=5 Participants
|
400 Participants
n=4 Participants
|
1165 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race-African
|
502 Participants
n=5 Participants
|
500 Participants
n=7 Participants
|
500 Participants
n=5 Participants
|
747 Participants
n=4 Participants
|
2249 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race-Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity-Mandinka
|
264 Participants
n=5 Participants
|
256 Participants
n=7 Participants
|
257 Participants
n=5 Participants
|
397 Participants
n=4 Participants
|
1174 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity-Wolof
|
47 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
217 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity-Fula
|
61 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
272 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity-Jola
|
63 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
280 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity-Serahule
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity-Serere
|
21 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity-Manjago
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity-Other
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
126 Participants
n=21 Participants
|
|
Region of Enrollment
Gambia
|
502 participants
n=5 Participants
|
501 participants
n=7 Participants
|
500 participants
n=5 Participants
|
747 participants
n=4 Participants
|
2250 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 4 weeks after the third dosePopulation: All subjects who received all primary series doses of study vaccines, had post-dose immunogenicity measurement(s) with no major protocol deviations
Serotype-specific concentrations of immunoglobulin G (IgG) antibody measured by ELISA
Outcome measures
| Measure |
Lot 1
n=487 Participants
Three doses of Pneumosil Lot 1
|
Lot 2
n=490 Participants
Three doses of Pneumosil Lot 2
|
Lot 3
n=481 Participants
Three doses of Pneumosil Lot 3
|
4 Weeks Post Booster-Synflorix
Three doses + 1 booster dose of Synflorix in a subset
|
|---|---|---|---|---|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody
Pn IgG Type 1
|
4.08 µg/mL
Interval 3.84 to 4.33
|
4.24 µg/mL
Interval 3.97 to 4.52
|
4.58 µg/mL
Interval 4.3 to 4.87
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody
Pn IgG Type 5
|
1.34 µg/mL
Interval 1.27 to 1.43
|
1.80 µg/mL
Interval 1.7 to 1.91
|
1.84 µg/mL
Interval 1.73 to 1.96
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody
Pn IgG Type 6A
|
1.05 µg/mL
Interval 0.95 to 1.15
|
0.95 µg/mL
Interval 0.86 to 1.06
|
1.01 µg/mL
Interval 0.91 to 1.11
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody
Pn IgG Type 6B
|
1.30 µg/mL
Interval 1.15 to 1.47
|
0.92 µg/mL
Interval 0.81 to 1.05
|
1.49 µg/mL
Interval 1.32 to 1.68
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody
Pn IgG Type 7F
|
2.79 µg/mL
Interval 2.61 to 2.98
|
2.55 µg/mL
Interval 2.37 to 2.75
|
3.70 µg/mL
Interval 3.46 to 3.96
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody
Pn IgG Type 9V
|
1.28 µg/mL
Interval 1.2 to 1.37
|
1.19 µg/mL
Interval 1.11 to 1.28
|
1.46 µg/mL
Interval 1.36 to 1.56
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody
Pn IgG Type 14
|
4.99 µg/mL
Interval 4.52 to 5.51
|
5.37 µg/mL
Interval 4.87 to 5.92
|
5.25 µg/mL
Interval 4.78 to 5.76
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody
Pn IgG Type 19A
|
1.53 µg/mL
Interval 1.42 to 1.66
|
1.66 µg/mL
Interval 1.53 to 1.79
|
1.74 µg/mL
Interval 1.61 to 1.88
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody
Pn IgG Type 19F
|
4.20 µg/mL
Interval 3.92 to 4.5
|
5.02 µg/mL
Interval 4.68 to 5.39
|
3.89 µg/mL
Interval 3.59 to 4.21
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody
Pn IgG Type 23F
|
1.61 µg/mL
Interval 1.48 to 1.74
|
1.57 µg/mL
Interval 1.44 to 1.72
|
1.56 µg/mL
Interval 1.44 to 1.7
|
—
|
PRIMARY outcome
Timeframe: 4 weeks after the third dosePopulation: Non-inferiority for each serotype is based on 2 non-inferiority criteria evaluation: for each serotype, non-inferiority was shown if a two-sided 97.5% CI for the absolute difference in proportions responding (PNEUMOSIL-Synflorix) had a lower limit \>-0.10, or if a two-sided 97.5% CI for the IgG GMC ratio (PNEUMOSIL/Synflorix) had a lower limit \>0.5.
Number and Percentage of subjects with serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL
Outcome measures
| Measure |
Lot 1
n=1458 Participants
Three doses of Pneumosil Lot 1
|
Lot 2
n=724 Participants
Three doses of Pneumosil Lot 2
|
Lot 3
Three doses of Pneumosil Lot 3
|
4 Weeks Post Booster-Synflorix
Three doses + 1 booster dose of Synflorix in a subset
|
|---|---|---|---|---|
|
Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL
Pn IgG Type 19A
|
1386 Participants
|
555 Participants
|
—
|
—
|
|
Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL
Pn IgG Type 1
|
1454 Participants
|
717 Participants
|
—
|
—
|
|
Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL
Pn IgG Type 5
|
1435 Participants
|
692 Participants
|
—
|
—
|
|
Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL
Pn IgG Type 6A
|
1193 Participants
|
555 Participants
|
—
|
—
|
|
Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL
Pn IgG Type 6B
|
1142 Participants
|
555 Participants
|
—
|
—
|
|
Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL
Pn IgG Type 7F
|
1443 Participants
|
709 Participants
|
—
|
—
|
|
Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL
Pn IgG Type 9V
|
1391 Participants
|
690 Participants
|
—
|
—
|
|
Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL
Pn IgG Type 14
|
1437 Participants
|
715 Participants
|
—
|
—
|
|
Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL
Pn IgG Type 19F
|
1427 Participants
|
713 Participants
|
—
|
—
|
|
Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL
Pn IgG Type 23F
|
1372 Participants
|
557 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 4 weeks after the third dosePopulation: Non-inferiority for each serotype is based on 2 non-inferiority criteria evaluation: for each serotype, non-inferiority was shown if a two-sided 97.5% CI for the absolute difference in proportions responding (PNEUMOSIL-Synflorix) had a lower limit \>-0.10, or if a two-sided 97.5% CI for the IgG GMC ratio (PNEUMOSIL/Synflorix) had a lower limit \>0.5.
Serotype-specific immunoglobulin G (IgG) geometric mean concentration (GMC) 4 weeks after the primary series of PNEUMOSIL/Synflorix co-administered with pentavalent, RV and polio vaccines.
Outcome measures
| Measure |
Lot 1
n=1458 Participants
Three doses of Pneumosil Lot 1
|
Lot 2
n=724 Participants
Three doses of Pneumosil Lot 2
|
Lot 3
Three doses of Pneumosil Lot 3
|
4 Weeks Post Booster-Synflorix
Three doses + 1 booster dose of Synflorix in a subset
|
|---|---|---|---|---|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody
Pn IgG Type 1
|
4.29 µg/mL
Interval 4.14 to 4.45
|
1.99 µg/mL
Interval 1.88 to 2.11
|
—
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody
Pn IgG Type 5
|
1.65 µg/mL
Interval 1.59 to 1.71
|
1.20 µg/mL
Interval 1.14 to 1.26
|
—
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody
Pn IgG Type 6A
|
1.00 µg/mL
Interval 0.95 to 1.06
|
1.13 µg/mL
Interval 1.02 to 1.25
|
—
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody
Pn IgG Type 6B
|
1.21 µg/mL
Interval 1.13 to 1.3
|
1.13 µg/mL
Interval 1.02 to 1.25
|
—
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody
Pn IgG Type 7F
|
2.97 µg/mL
Interval 2.85 to 3.1
|
2.29 µg/mL
Interval 2.16 to 2.43
|
—
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody
Pn IgG Type 9V
|
1.31 µg/mL
Interval 1.26 to 1.36
|
1.42 µg/mL
Interval 1.34 to 1.5
|
—
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody
Pn IgG Type 14
|
5.20 µg/mL
Interval 4.92 to 5.5
|
4.24 µg/mL
Interval 3.9 to 4.61
|
—
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody
Pn IgG Type 19A
|
1.64 µg/mL
Interval 1.57 to 1.72
|
1.13 µg/mL
Interval 1.02 to 1.25
|
—
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody
Pn IgG Type 19F
|
4.35 µg/mL
Interval 4.17 to 4.54
|
5.93 µg/mL
Interval 5.5 to 6.39
|
—
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody
Pn IgG Type 23F
|
1.58 µg/mL
Interval 1.51 to 1.66
|
0.87 µg/mL
Interval 0.8 to 0.95
|
—
|
—
|
PRIMARY outcome
Timeframe: 4 weeks after the third dosePopulation: Evaluated in a subset who got 3 primary doses, had postdose immunogenicity data with no major protocol deviations.For each Ag in the pentavalent, RV, OPV vaccines, non-inferiority shown if 2-sided 95% CI for difference in response proportions (PNEUMOSIL-Synflorix) had lower limit \>-0.10. For this, pooled PNUEMOSIL data was used as specified in SAP.
Subjects with 1) anti-diphtheria toxoid (DT) and anti-tetanus toxoid (DT) IgG concentration ≥ 0.1 IU/mL; 2) anti-Hepatitis B surface antigen (HBsAg) IgG concentration ≥ 10 mIU/mL; 3) anti-Hib (polyribosylribitol phosphate \[PRP\]) IgG concentration ≥ 0.15 µg/mL; 4) anti-poliovirus types 1, 2 and 3 neutralizing antibody titers ≥ 1:8; 5) anti-rotavirus IgA concentration ≥ 20 U/mL.
Outcome measures
| Measure |
Lot 1
n=447 Participants
Three doses of Pneumosil Lot 1
|
Lot 2
n=225 Participants
Three doses of Pneumosil Lot 2
|
Lot 3
Three doses of Pneumosil Lot 3
|
4 Weeks Post Booster-Synflorix
Three doses + 1 booster dose of Synflorix in a subset
|
|---|---|---|---|---|
|
Number and Percentage of Subjects With EPI Vaccine Immune Responses (Diphtheria, Tetanus, Hepatitis B, Hib, Polio and Rotavirus)
Anti-Diphtheria Toxoid ≥ 0.1 IU/mL
|
447 Participants
|
225 Participants
|
—
|
—
|
|
Number and Percentage of Subjects With EPI Vaccine Immune Responses (Diphtheria, Tetanus, Hepatitis B, Hib, Polio and Rotavirus)
Anti-Tetanus Toxoid ≥ 0.1 IU/mL
|
447 Participants
|
225 Participants
|
—
|
—
|
|
Number and Percentage of Subjects With EPI Vaccine Immune Responses (Diphtheria, Tetanus, Hepatitis B, Hib, Polio and Rotavirus)
Anti-HBsAg concentration ≥ 10 mIU/mL
|
447 Participants
|
224 Participants
|
—
|
—
|
|
Number and Percentage of Subjects With EPI Vaccine Immune Responses (Diphtheria, Tetanus, Hepatitis B, Hib, Polio and Rotavirus)
Anti-PRP concentration ≥ 0.15 μg/mL
|
441 Participants
|
224 Participants
|
—
|
—
|
|
Number and Percentage of Subjects With EPI Vaccine Immune Responses (Diphtheria, Tetanus, Hepatitis B, Hib, Polio and Rotavirus)
Anti-Polio titer ≥ 1:8 (type 1)
|
446 Participants
|
225 Participants
|
—
|
—
|
|
Number and Percentage of Subjects With EPI Vaccine Immune Responses (Diphtheria, Tetanus, Hepatitis B, Hib, Polio and Rotavirus)
Anti-Polio titer ≥ 1:8 (type 2)
|
374 Participants
|
182 Participants
|
—
|
—
|
|
Number and Percentage of Subjects With EPI Vaccine Immune Responses (Diphtheria, Tetanus, Hepatitis B, Hib, Polio and Rotavirus)
Anti-Polio titer ≥ 1:8 (type 3)
|
437 Participants
|
222 Participants
|
—
|
—
|
|
Number and Percentage of Subjects With EPI Vaccine Immune Responses (Diphtheria, Tetanus, Hepatitis B, Hib, Polio and Rotavirus)
Anti-Rotavirus concentration ≥ 20 U/mL
|
122 Participants
|
61 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 4 weeks after the third dosePopulation: Evaluated in a subset who got 3 primary doses, had postdose immunogenicity data with no major protocol deviations.Non-inferiority was defined as 2-sided 95% CI for the GMC ratio (PNEUMOSIL/Synflorix) with lower limit\>0.5 for each of 2 separate antigens (pertussis toxoid and fimbriae).For this analysis, pooled PNUEMOSIL data used as specified in SAP
Anti-pertussis toxoid GMCs for the pertussis antigen
Outcome measures
| Measure |
Lot 1
n=447 Participants
Three doses of Pneumosil Lot 1
|
Lot 2
n=225 Participants
Three doses of Pneumosil Lot 2
|
Lot 3
Three doses of Pneumosil Lot 3
|
4 Weeks Post Booster-Synflorix
Three doses + 1 booster dose of Synflorix in a subset
|
|---|---|---|---|---|
|
Anti-pertussis Toxoid GMCs for the Pertussis Antigen
|
50.95 IU/mL
Interval 43.13 to 60.2
|
61.82 IU/mL
Interval 49.58 to 77.09
|
—
|
—
|
PRIMARY outcome
Timeframe: 4 weeks after the third dosePopulation: Evaluated in a subset of subjects who received all primary series doses, had postdose immunogenicity results with no major protocol deviations. Non-inferiority was defined as a two-sided 95% CI for the GMC ratio (PNEUMOSIL/Synflorix) with lower limit \> 0.5 for each of 2 separate antigens (pertussis toxoid and fimbriae).
Anti fimbriae 2/3 IgG GMCs for the pertussis antigen
Outcome measures
| Measure |
Lot 1
n=447 Participants
Three doses of Pneumosil Lot 1
|
Lot 2
n=225 Participants
Three doses of Pneumosil Lot 2
|
Lot 3
Three doses of Pneumosil Lot 3
|
4 Weeks Post Booster-Synflorix
Three doses + 1 booster dose of Synflorix in a subset
|
|---|---|---|---|---|
|
Anti Fimbriae 2/3 IgG GMCs for the Pertussis Antigen
|
317.97 U/mL
Interval 275.91 to 366.45
|
324.87 U/mL
Interval 267.34 to 394.78
|
—
|
—
|
PRIMARY outcome
Timeframe: 7 days (including day of vaccination)Population: Sample size for evaluation of solicited local and systemic AEs was approx. 1,125. Evaluated in a subset of subjects who got a study vaccine and had some post-vaccination safety data. Lotwise data was used for clinical lot equivalence evaluation, for safety analyses pooled PNUEMOSIL data was used as specified in SAP.
In the primary reactogenicity cohort, local and systemic reactogenicity of the study vaccine was evaluated through day 6 for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[life threatening\].
Outcome measures
| Measure |
Lot 1
n=751 Participants
Three doses of Pneumosil Lot 1
|
Lot 2
n=364 Participants
Three doses of Pneumosil Lot 2
|
Lot 3
Three doses of Pneumosil Lot 3
|
4 Weeks Post Booster-Synflorix
Three doses + 1 booster dose of Synflorix in a subset
|
|---|---|---|---|---|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1
Temperature · Grade 0
|
516 Participants
|
249 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1
Temperature · Grade 1
|
183 Participants
|
88 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1
Temperature · Grade 2
|
52 Participants
|
27 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1
Cutaneous Rash · Grade 0
|
731 Participants
|
353 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1
Cutaneous Rash · Grade 1
|
19 Participants
|
10 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1
Cutaneous Rash · Grade 2
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1
Irritability · Grade 0
|
619 Participants
|
301 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1
Irritability · Grade 1
|
127 Participants
|
57 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1
Irritability · Grade 2
|
5 Participants
|
6 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1
Drowsiness · Grade 0
|
732 Participants
|
352 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1
Drowsiness · Grade 1
|
19 Participants
|
12 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1
Drowsiness · Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1
Decreased Appetite · Grade 0
|
728 Participants
|
349 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1
Decreased Appetite · Grade 1
|
22 Participants
|
12 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1
Decreased Appetite · Grade 2
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1
Tenderness · Grade 0
|
539 Participants
|
251 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1
Tenderness · Grade 1
|
185 Participants
|
93 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1
Tenderness · Grade 2
|
27 Participants
|
20 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1
Erythema/Redness · Grade 0
|
736 Participants
|
350 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1
Erythema/Redness · Grade 1
|
15 Participants
|
13 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1
Erythema/Redness · Grade 2
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1
Induration/Swelling · Grade 0
|
731 Participants
|
345 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1
Induration/Swelling · Grade 1
|
17 Participants
|
16 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1
Induration/Swelling · Grade 2
|
3 Participants
|
3 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 7 days (including day of vaccination)Population: Sample size for evaluation of solicited local and systemic AEs was approx. 1,125. Evaluated in a subset of subjects who got a study vaccine and had some post-vaccination safety data. Lotwise data was used for clinical lot equivalence evaluation, for safety analyses pooled PNUEMOSIL data was used as specified in SAP.
In the primary reactogenicity cohort, local and systemic reactogenicity of the study vaccine was evaluated through day 6 for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[life threatening\].
Outcome measures
| Measure |
Lot 1
n=739 Participants
Three doses of Pneumosil Lot 1
|
Lot 2
n=361 Participants
Three doses of Pneumosil Lot 2
|
Lot 3
Three doses of Pneumosil Lot 3
|
4 Weeks Post Booster-Synflorix
Three doses + 1 booster dose of Synflorix in a subset
|
|---|---|---|---|---|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Drowsiness · Grade 1
|
13 Participants
|
2 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Temperature · Grade 0
|
590 Participants
|
271 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Temperature · Grade 1
|
121 Participants
|
70 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Temperature · Grade 2
|
25 Participants
|
19 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Temperature · Grade 3
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Cutaneous Rash · Grade 0
|
727 Participants
|
355 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Cutaneous Rash · Grade 1
|
10 Participants
|
4 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Cutaneous Rash · Grade 2
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Cutaneous Rash · Grade 3
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Irritability · Grade 0
|
646 Participants
|
324 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Irritability · Grade 1
|
84 Participants
|
36 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Irritability · Grade 2
|
8 Participants
|
1 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Irritability · Grade 3
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Drowsiness · Grade 0
|
726 Participants
|
359 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Drowsiness · Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Drowsiness · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Decreased Appetite · Grade 0
|
728 Participants
|
354 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Decreased Appetite · Grade 1
|
10 Participants
|
4 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Decreased Appetite · Grade 2
|
0 Participants
|
3 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Decreased Appetite · Grade 3
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Tenderness · Grade 0
|
585 Participants
|
283 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Tenderness · Grade 1
|
127 Participants
|
63 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Tenderness · Grade 2
|
27 Participants
|
15 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Tenderness · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Erythema/Redness · Grade 0
|
725 Participants
|
356 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Erythema/Redness · Grade 1
|
14 Participants
|
5 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Erythema/Redness · Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Erythema/Redness · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Induration/Swelling · Grade 0
|
724 Participants
|
348 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Induration/Swelling · Grade 1
|
14 Participants
|
11 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Induration/Swelling · Grade 2
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
Induration/Swelling · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 7 days (including day of vaccination)Population: Sample size for evaluation of solicited local and systemic AEs was approx. 1,125. Evaluated in a subset of subjects who got a study vaccine and had some post-vaccination safety data. Lotwise data was used for clinical lot equivalence evaluation, for safety analyses pooled PNUEMOSIL data was used as specified in SAP.
In the primary reactogenicity cohort, local and systemic reactogenicity of the study vaccine was evaluated through day 6 for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[life threatening\].
Outcome measures
| Measure |
Lot 1
n=735 Participants
Three doses of Pneumosil Lot 1
|
Lot 2
n=360 Participants
Three doses of Pneumosil Lot 2
|
Lot 3
Three doses of Pneumosil Lot 3
|
4 Weeks Post Booster-Synflorix
Three doses + 1 booster dose of Synflorix in a subset
|
|---|---|---|---|---|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Cutaneous Rash · Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Cutaneous Rash · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Temperature · Grade 0
|
576 Participants
|
301 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Temperature · Grade 1
|
122 Participants
|
51 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Temperature · Grade 2
|
37 Participants
|
7 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Temperature · Grade 3
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Temperature · Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Cutaneous Rash · Grade 0
|
726 Participants
|
358 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Cutaneous Rash · Grade 1
|
9 Participants
|
2 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Cutaneous Rash · Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Irritability · Grade 0
|
657 Participants
|
316 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Irritability · Grade 1
|
74 Participants
|
41 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Irritability · Grade 2
|
3 Participants
|
3 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Irritability · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Irritability · Grade 4
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Drowsiness · Grade 0
|
717 Participants
|
352 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Drowsiness · Grade 1
|
17 Participants
|
8 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Drowsiness · Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Drowsiness · Grade 3
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Drowsiness · Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Decreased Appetite · Grade 0
|
716 Participants
|
353 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Decreased Appetite · Grade 1
|
17 Participants
|
6 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Decreased Appetite · Grade 2
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Decreased Appetite · Grade 3
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Decreased Appetite · Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Tenderness · Grade 0
|
605 Participants
|
296 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Tenderness · Grade 1
|
110 Participants
|
55 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Tenderness · Grade 2
|
20 Participants
|
9 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Tenderness · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Tenderness · Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Erythema/Redness · Grade 0
|
730 Participants
|
357 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Erythema/Redness · Grade 1
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Erythema/Redness · Grade 2
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Erythema/Redness · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Erythema/Redness · Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Induration/Swelling · Grade 0
|
727 Participants
|
353 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Induration/Swelling · Grade 1
|
7 Participants
|
6 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Induration/Swelling · Grade 2
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Induration/Swelling · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
Induration/Swelling · Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 7 days (including day of vaccination)Population: Reported in a subset of subjects who got 3 doses and booster dose of the study vaccine and had post-vaccination safety data.Treatment groups (PNUEMOSIL or Synflorix) were based on actual treatment received at Visit 1. Lotwise data was used for clinical lot equivalence evaluation, for safety analyses pooled PNUEMOSIL data was used (specified in SAP)
In the primary reactogenicity cohort, local and systemic reactogenicity of the study vaccine was evaluated through day 6 for severity by toxicity grading scale (0 \[none\], 1 \[mild\], 2 \[moderate\], 3 \[severe\], 4 \[life threatening\].
Outcome measures
| Measure |
Lot 1
n=428 Participants
Three doses of Pneumosil Lot 1
|
Lot 2
n=213 Participants
Three doses of Pneumosil Lot 2
|
Lot 3
Three doses of Pneumosil Lot 3
|
4 Weeks Post Booster-Synflorix
Three doses + 1 booster dose of Synflorix in a subset
|
|---|---|---|---|---|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Temperature · Grade 0
|
404 Participants
|
197 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Temperature · Grade 1
|
14 Participants
|
12 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Temperature · Grade 2
|
9 Participants
|
4 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Temperature · Grade 3
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Cutaneous Rash · Grade 0
|
424 Participants
|
211 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Cutaneous Rash · Grade 1
|
4 Participants
|
2 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Cutaneous Rash · Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Cutaneous Rash · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Irritability · Grade 0
|
415 Participants
|
207 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Irritability · Grade 1
|
12 Participants
|
6 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Irritability · Grade 2
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Irritability · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Drowsiness · Grade 0
|
418 Participants
|
208 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Drowsiness · Grade 1
|
9 Participants
|
5 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Drowsiness · Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Drowsiness · Grade 3
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Decreased Appetite · Grade 0
|
425 Participants
|
211 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Decreased Appetite · Grade 1
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Decreased Appetite · Grade 2
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Decreased Appetite · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Tenderness · Grade 0
|
395 Participants
|
200 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Tenderness · Grade 1
|
28 Participants
|
9 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Tenderness · Grade 2
|
5 Participants
|
4 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Tenderness · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Erythema/Redness · Grade 0
|
428 Participants
|
213 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Erythema/Redness · Grade 1
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Erythema/Redness · Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Erythema/Redness · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Induration/Swelling · Grade 0
|
423 Participants
|
209 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Induration/Swelling · Grade 1
|
5 Participants
|
4 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Induration/Swelling · Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
Induration/Swelling · Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 4 weeks post last vaccinationPopulation: Evaluated in all subjects who received a study vaccination and provided some post-vaccination safety data. Treatment groups (PNUEMOSIL or Synflorix) were based on actual treatment received at Visit 1. Lotwise data was used for clinical lot equivalence evaluation, for safety analyses pooled PNUEMOSIL data was used as specified in SAP.
All subjects were followed up for AEs till 4 weeks post vaccination dose 3 and subjects in the booster cohort were followed up for AEs till 4 weeks post booster vaccination
Outcome measures
| Measure |
Lot 1
n=1503 Participants
Three doses of Pneumosil Lot 1
|
Lot 2
n=747 Participants
Three doses of Pneumosil Lot 2
|
Lot 3
Three doses of Pneumosil Lot 3
|
4 Weeks Post Booster-Synflorix
Three doses + 1 booster dose of Synflorix in a subset
|
|---|---|---|---|---|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Upper respiratory tract infection · None
|
739 Participants
|
355 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Furuncle · Mild-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Furuncle · Mild-Not related
|
142 Participants
|
62 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Tinea capitis · Severe-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Oral candidiasis · Mild-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Oral candidiasis · Mild-Not related
|
31 Participants
|
15 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Rash pustular · Mild-Not related
|
25 Participants
|
15 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Rash pustular · Moderate-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Dermatitis contact · Moderate-Not related
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Upper respiratory tract infection · Mild-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Upper respiratory tract infection · Mild-Not related
|
714 Participants
|
366 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Upper respiratory tract infection · Moderate-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Upper respiratory tract infection · Moderate-Not related
|
48 Participants
|
26 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Upper respiratory tract infection · Severe-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Upper respiratory tract infection · Severe-Not related
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Furuncle · Moderate-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Furuncle · Moderate-Not related
|
11 Participants
|
3 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Furuncle · Severe-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Furuncle · Severe-Not related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Furuncle · None
|
1350 Participants
|
682 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Gastroenteritis · Mild-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Gastroenteritis · Mild-Not related
|
125 Participants
|
67 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Gastroenteritis · Moderate-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Gastroenteritis · Moderate-Not related
|
27 Participants
|
7 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Gastroenteritis · Severe-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Gastroenteritis · Severe-Not related
|
5 Participants
|
3 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Gastroenteritis · None
|
1346 Participants
|
670 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Conjunctivitis · Mild-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Conjunctivitis · Mild-Not related
|
103 Participants
|
62 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Conjunctivitis · Moderate-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Conjunctivitis · Moderate-Not related
|
8 Participants
|
2 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Conjunctivitis · Severe-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Conjunctivitis · Severe-Not related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Conjunctivitis · None
|
1392 Participants
|
683 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Bronchiolitis · Mild-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Bronchiolitis · Mild-Not related
|
30 Participants
|
32 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Bronchiolitis · Moderate-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Bronchiolitis · Moderate-Not related
|
20 Participants
|
8 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Bronchiolitis · Severe-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Bronchiolitis · Severe-Not related
|
13 Participants
|
4 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Bronchiolitis · None
|
1440 Participants
|
703 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Tinea infection · Mild-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Tinea infection · Mild-Not related
|
59 Participants
|
21 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Tinea infection · Moderate-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Tinea infection · Moderate-Not related
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Tinea infection · Severe-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Tinea infection · Severe-Not related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Tinea infection · None
|
1441 Participants
|
725 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Febrile infection · Mild-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Febrile infection · Mild-Not related
|
44 Participants
|
20 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Febrile infection · Moderate-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Febrile infection · Moderate-Not related
|
9 Participants
|
7 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Febrile infection · Severe-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Febrile infection · Severe-Not related
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Febrile infection · None
|
1450 Participants
|
719 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Pneumonia · Mild-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Pneumonia · Mild-Not related
|
17 Participants
|
10 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Pneumonia · Moderate-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Pneumonia · Moderate-Not related
|
21 Participants
|
5 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Pneumonia · Severe-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Pneumonia · Severe-Not related
|
5 Participants
|
6 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Pneumonia · None
|
1460 Participants
|
726 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Tinea capitis · Mild-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Tinea capitis · Mild-Not related
|
29 Participants
|
22 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Tinea capitis · Moderate-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Tinea capitis · Moderate-Not related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Tinea capitis · Severe-Not related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Tinea capitis · None
|
1474 Participants
|
725 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Oral candidiasis · Moderate-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Oral candidiasis · Moderate-Not related
|
4 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Oral candidiasis · Severe-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Oral candidiasis · Severe-Not related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Oral candidiasis · None
|
1468 Participants
|
732 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Body tinea · Mild-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Body tinea · Mild-Not related
|
27 Participants
|
18 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Body tinea · Moderate-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Body tinea · Moderate-Not related
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Body tinea · Severe-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Body tinea · Severe-Not related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Body tinea · None
|
1474 Participants
|
729 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Impetigo · Mild-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Impetigo · Mild-Not related
|
24 Participants
|
19 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Impetigo · Moderate-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Impetigo · Moderate-Not related
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Impetigo · Severe-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Impetigo · Severe-Not related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Impetigo · None
|
1476 Participants
|
728 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Rash pustular · Mild-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Rash pustular · Moderate-Not related
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Rash pustular · Severe-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Rash pustular · Severe-Not related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Rash pustular · None
|
1478 Participants
|
731 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Skin candida · Mild-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Skin candida · Mild-Not related
|
14 Participants
|
11 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Skin candida · Moderate-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Skin candida · Moderate-Not related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Skin candida · Severe-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Skin candida · Severe-Not related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Skin candida · None
|
1489 Participants
|
736 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Diarrhoea · Mild-Related
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Diarrhoea · Mild-Not related
|
268 Participants
|
130 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Diarrhoea · Moderate-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Diarrhoea · Moderate-Not related
|
16 Participants
|
3 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Diarrhoea · Severe-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Diarrhoea · Severe-Not related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Diarrhoea · None
|
1218 Participants
|
614 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Vomiting · Mild-Related
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Vomiting · Mild-Not related
|
22 Participants
|
12 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Vomiting · Moderate-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Vomiting · Moderate-Not related
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Vomiting · Severe-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Vomiting · Severe-Not related
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Vomiting · None
|
1478 Participants
|
734 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Dermatitis diaper · Mild-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Dermatitis diaper · Mild-Not related
|
34 Participants
|
27 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Dermatitis diaper · Moderate-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Dermatitis diaper · Moderate-Not related
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Dermatitis diaper · Severe-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Dermatitis diaper · Severe-Not related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Dermatitis diaper · None
|
1467 Participants
|
719 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Rash maculo-papular · Mild-Related
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Rash maculo-papular · Mild-Not related
|
37 Participants
|
14 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Rash maculo-papular · Moderate-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Rash maculo-papular · Moderate-Not related
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Rash maculo-papular · Severe-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Rash maculo-papular · Severe-Not related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Rash maculo-papular · None
|
1466 Participants
|
730 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Rash papular · Mild-Related
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Rash papular · Mild-Not related
|
19 Participants
|
11 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Rash papular · Moderate-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Rash papular · Moderate-Not related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Rash papular · Severe-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Rash papular · Severe-Not related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Rash papular · None
|
1483 Participants
|
736 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Dermatitis contact · Mild-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Dermatitis contact · Mild-Not related
|
16 Participants
|
7 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Dermatitis contact · Moderate-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Dermatitis contact · Severe-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Dermatitis contact · Severe-Not related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Dermatitis contact · None
|
1485 Participants
|
740 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Dermatitis atopic · Mild-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Dermatitis atopic · Mild-Not related
|
12 Participants
|
10 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Dermatitis atopic · Moderate-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Dermatitis atopic · Moderate-Not related
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Dermatitis atopic · Severe-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Dermatitis atopic · Severe-Not related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Dermatitis atopic · None
|
1491 Participants
|
736 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Seborrhoeic dermatitis · Mild-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Seborrhoeic dermatitis · Mild-Not related
|
16 Participants
|
5 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Seborrhoeic dermatitis · Moderate-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Seborrhoeic dermatitis · Moderate-Not related
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Seborrhoeic dermatitis · Severe-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Seborrhoeic dermatitis · Severe-Not related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Seborrhoeic dermatitis · None
|
1486 Participants
|
742 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Cough · Mild-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Cough · Mild-Not related
|
95 Participants
|
38 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Cough · Moderate-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Cough · Moderate-Not related
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Cough · Severe-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Cough · Severe-Not related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Cough · None
|
1408 Participants
|
708 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Pyrexia · Mild-Related
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Pyrexia · Mild-Not related
|
17 Participants
|
15 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Pyrexia · Moderate-Related
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Pyrexia · Moderate-Not related
|
8 Participants
|
1 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Pyrexia · Severe-Related
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Pyrexia · Severe-Not related
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Pyrexia · None
|
1472 Participants
|
731 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Thermal burn · Mild-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Thermal burn · Mild-Not related
|
7 Participants
|
10 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Thermal burn · Moderate-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Thermal burn · Moderate-Not related
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Thermal burn · Severe-Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Thermal burn · Severe-Not related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
Thermal burn · None
|
1494 Participants
|
736 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 4 weeks post last vaccinationPopulation: Evaluated in all subjects who received a study vaccination and provided some post-vaccination safety data. Treatment groups (PNUEMOSIL or Synflorix) were based on actual treatment received at Visit 1. Lotwise data was used for clinical lot equivalence evaluation, for safety analyses pooled PNUEMOSIL data was used as specified in SAP.
All subjects were followed up for SAEs till 4 weeks post vaccination dose 3 and subjects in the booster cohort were followed up for SAEs till 4 weeks post booster vaccination
Outcome measures
| Measure |
Lot 1
n=1503 Participants
Three doses of Pneumosil Lot 1
|
Lot 2
n=747 Participants
Three doses of Pneumosil Lot 2
|
Lot 3
Three doses of Pneumosil Lot 3
|
4 Weeks Post Booster-Synflorix
Three doses + 1 booster dose of Synflorix in a subset
|
|---|---|---|---|---|
|
Number and Percentage of All SAEs by Severity and Relatedness
Intussusception · Moderate-Not Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Intussusception · Severe-Not Related
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Developmental delay · None
|
1502 Participants
|
747 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Malnutrition · Moderate-Not Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Bronchiolitis · Moderate-Not Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Bronchiolitis · Severe-Not Related
|
13 Participants
|
4 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Bronchiolitis · None
|
1490 Participants
|
743 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Gastroenteritis · Moderate-Not Related
|
4 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Gastroenteritis · Severe-Not Related
|
5 Participants
|
3 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Gastroenteritis · None
|
1494 Participants
|
744 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Pneumonia · Moderate-Not Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Pneumonia · Severe-Not Related
|
4 Participants
|
6 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Pneumonia · None
|
1499 Participants
|
741 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Dysentery · Moderate-Not Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Dysentery · Severe-Not Related
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Dysentery · None
|
1503 Participants
|
746 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Febrile infection · Moderate-Not Related
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Febrile infection · Severe-Not Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Febrile infection · None
|
1503 Participants
|
746 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
HIV infection WHO clinical stage IV · Moderate-Not Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
HIV infection WHO clinical stage IV · Severe-Not Related
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
HIV infection WHO clinical stage IV · None
|
1503 Participants
|
746 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Meningitis pneumococcal · Moderate-Not Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Meningitis pneumococcal · Severe-Not Related
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Meningitis pneumococcal · None
|
1502 Participants
|
747 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Perinatal HIV infection · Moderate-Not Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Perinatal HIV infection · Severe-Not Related
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Perinatal HIV infection · None
|
1503 Participants
|
746 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Periorbital cellulitis · Moderate-Not Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Periorbital cellulitis · Severe-Not Related
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Periorbital cellulitis · None
|
1503 Participants
|
746 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Upper respiratory tract infection · Moderate-Not Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Upper respiratory tract infection · Severe-Not Related
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Upper respiratory tract infection · None
|
1502 Participants
|
747 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Fallot's tetralogy · Moderate-Not Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Fallot's tetralogy · Severe-Not Related
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Fallot's tetralogy · None
|
1502 Participants
|
746 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Trisomy 21 · Moderate-Not Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Trisomy 21 · Severe-Not Related
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Trisomy 21 · None
|
1501 Participants
|
747 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Atrioventricular septal defect · Moderate-Not Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Atrioventricular septal defect · Severe-Not Related
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Atrioventricular septal defect · None
|
1502 Participants
|
747 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Intussusception · None
|
1501 Participants
|
747 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Diarrhoea haemorrhagic · Moderate-Not Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Diarrhoea haemorrhagic · Severe-Not Related
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Diarrhoea haemorrhagic · None
|
1502 Participants
|
747 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Vomiting · Moderate-Not Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Vomiting · Severe-Not Related
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Vomiting · None
|
1502 Participants
|
747 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Developmental delay · Moderate-Not Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Developmental delay · Severe-Not Related
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Malnutrition · Severe-Not Related
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Malnutrition · None
|
1503 Participants
|
746 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Seizure · Moderate-Not Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Seizure · Severe-Not Related
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Seizure · None
|
1502 Participants
|
747 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Epistaxis · Moderate-Not Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Epistaxis · Severe-Not Related
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Epistaxis · None
|
1502 Participants
|
747 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Stevens-Johnson syndrome · Moderate-Not Related
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Stevens-Johnson syndrome · Severe-Not Related
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number and Percentage of All SAEs by Severity and Relatedness
Stevens-Johnson syndrome · None
|
1502 Participants
|
747 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after the third dosePopulation: For 6A and 19A serotypes, proportions with IgG concentration ≥ 0.35 µg/mL were compared using a z-test for proportions.Test was done at the 2-sided 2.5% significance level to adjust for superiority test. Analysis was done on pooled PNEUMOSIL data as specified in SAP
Subjects with 6A and 19A serotype-specific concentrations of immunoglobulin G (IgG) antibody measured by ELISA
Outcome measures
| Measure |
Lot 1
n=1458 Participants
Three doses of Pneumosil Lot 1
|
Lot 2
n=724 Participants
Three doses of Pneumosil Lot 2
|
Lot 3
Three doses of Pneumosil Lot 3
|
4 Weeks Post Booster-Synflorix
Three doses + 1 booster dose of Synflorix in a subset
|
|---|---|---|---|---|
|
Number and Percentage of Subjects With 6A and 19A Serotype-specific Concentrations of Immunoglobulin G Antibody
Pn IgG Type 6A
|
1193 Participants
|
62 Participants
|
—
|
—
|
|
Number and Percentage of Subjects With 6A and 19A Serotype-specific Concentrations of Immunoglobulin G Antibody
Pn IgG Type 19A
|
1386 Participants
|
293 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after the third dosePopulation: For 6A and 19A serotypes, GMCs were compared by a two-sample t-test on the difference.Test was done at the 2-sided 2.5% significance level to adjust for superiority test.The 95% CIs around treatment-group responses, and 97.5% CIs for treatment-group differences in response were reported.Analysis was done on pooled PNEUMOSIL data as specified in SAP
6A and 19A Serotype Specific Immune Responses in terms of IgG GMCs measured by ELISA
Outcome measures
| Measure |
Lot 1
n=1458 Participants
Three doses of Pneumosil Lot 1
|
Lot 2
n=724 Participants
Three doses of Pneumosil Lot 2
|
Lot 3
Three doses of Pneumosil Lot 3
|
4 Weeks Post Booster-Synflorix
Three doses + 1 booster dose of Synflorix in a subset
|
|---|---|---|---|---|
|
6A and 19A Serotype Specific Geometric Mean Concentration of IgG Antibody
Pn IgG Type 6A
|
1.00 µg/mL
Interval 0.95 to 1.06
|
0.12 µg/mL
Interval 0.11 to 0.12
|
—
|
—
|
|
6A and 19A Serotype Specific Geometric Mean Concentration of IgG Antibody
Pn IgG Type 19A
|
1.64 µg/mL
Interval 1.57 to 1.72
|
0.29 µg/mL
Interval 0.27 to 0.31
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after the third dosePopulation: In a subset of subjects who got 3 primary doses of study vaccines, had postdose immunogenicity measurement and no major protocol deviations, functional immune responses induced by PNEUMOSIL were compared to Synflorix for 10 serotypes in PNEUMOSIL, i.e., OPA seroresponse rate (titer≥1:8) differences.Pooled PNEUMOSIL data was used as noted in the SAP
Serotype-specific functional antibody titer measured by OPA
Outcome measures
| Measure |
Lot 1
n=247 Participants
Three doses of Pneumosil Lot 1
|
Lot 2
n=250 Participants
Three doses of Pneumosil Lot 2
|
Lot 3
Three doses of Pneumosil Lot 3
|
4 Weeks Post Booster-Synflorix
Three doses + 1 booster dose of Synflorix in a subset
|
|---|---|---|---|---|
|
Number and Percentage of Subjects With Functional Antibody Responses
OPA Type 19A
|
228 Participants
|
92 Participants
|
—
|
—
|
|
Number and Percentage of Subjects With Functional Antibody Responses
OPA Type 1
|
229 Participants
|
188 Participants
|
—
|
—
|
|
Number and Percentage of Subjects With Functional Antibody Responses
OPA Type 5
|
244 Participants
|
239 Participants
|
—
|
—
|
|
Number and Percentage of Subjects With Functional Antibody Responses
OPA Type 6A
|
240 Participants
|
36 Participants
|
—
|
—
|
|
Number and Percentage of Subjects With Functional Antibody Responses
OPA Type 6B
|
233 Participants
|
212 Participants
|
—
|
—
|
|
Number and Percentage of Subjects With Functional Antibody Responses
OPA Type 7F
|
247 Participants
|
249 Participants
|
—
|
—
|
|
Number and Percentage of Subjects With Functional Antibody Responses
OPA Type 9V
|
242 Participants
|
249 Participants
|
—
|
—
|
|
Number and Percentage of Subjects With Functional Antibody Responses
OPA Type 14
|
237 Participants
|
242 Participants
|
—
|
—
|
|
Number and Percentage of Subjects With Functional Antibody Responses
OPA Type 19F
|
239 Participants
|
246 Participants
|
—
|
—
|
|
Number and Percentage of Subjects With Functional Antibody Responses
OPA Type 23F
|
246 Participants
|
243 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after the third dosePopulation: In a subset of subjects who got 3 primary doses of study vaccines, had postdose immunogenicity measurement and no major protocol deviations, functional immune responses induced by PNEUMOSIL were compared to Synflorix for 10 serotypes in PNEUMOSIL, i.e., ratio of OPA GMTs (and corresponding 95% CIs).Pooled PNEUMOSIL data was used as noted in the SAP
Serotype-specific functional antibody titer measured by OPA and expressed as OPA GMT in a subset
Outcome measures
| Measure |
Lot 1
n=247 Participants
Three doses of Pneumosil Lot 1
|
Lot 2
n=250 Participants
Three doses of Pneumosil Lot 2
|
Lot 3
Three doses of Pneumosil Lot 3
|
4 Weeks Post Booster-Synflorix
Three doses + 1 booster dose of Synflorix in a subset
|
|---|---|---|---|---|
|
Serotype-specific OPA Geometric Mean Titer
OPA 19F
|
594.27 titer
Interval 509.98 to 692.49
|
895.39 titer
Interval 784.96 to 1021.35
|
—
|
—
|
|
Serotype-specific OPA Geometric Mean Titer
OPA 23F
|
767.24 titer
Interval 648.95 to 907.1
|
253.09 titer
Interval 197.1 to 325.0
|
—
|
—
|
|
Serotype-specific OPA Geometric Mean Titer
OPA Type 1
|
85.17 titer
Interval 71.34 to 101.69
|
27.55 titer
Interval 22.96 to 33.06
|
—
|
—
|
|
Serotype-specific OPA Geometric Mean Titer
OPA Type 5
|
161.34 titer
Interval 139.94 to 186.02
|
115.93 titer
Interval 98.85 to 135.97
|
—
|
—
|
|
Serotype-specific OPA Geometric Mean Titer
OPA Type 6A
|
1317.16 titer
Interval 1109.36 to 1563.88
|
7.06 titer
Interval 5.83 to 8.56
|
—
|
—
|
|
Serotype-specific OPA Geometric Mean Titer
OPA Type 6B
|
913.52 titer
Interval 745.97 to 1118.7
|
467.65 titer
Interval 365.27 to 598.73
|
—
|
—
|
|
Serotype-specific OPA Geometric Mean Titer
OPA Type 7F
|
1833.71 titer
Interval 1612.31 to 2085.51
|
1586.75 titer
Interval 1392.62 to 1807.94
|
—
|
—
|
|
Serotype-specific OPA Geometric Mean Titer
OPA Type 9V
|
141.72 titer
Interval 113.36 to 177.16
|
376.77 titer
Interval 324.01 to 438.13
|
—
|
—
|
|
Serotype-specific OPA Geometric Mean Titer
OPA Type 14
|
1019.34 titer
Interval 816.53 to 1272.52
|
1102.64 titer
Interval 878.56 to 1383.87
|
—
|
—
|
|
Serotype-specific OPA Geometric Mean Titer
OPA 19A
|
148.59 titer
Interval 121.35 to 181.95
|
11.09 titer
Interval 9.19 to 13.39
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks post booster vaccinationPopulation: In a subset who got 3 primary series+booster dose of study vaccines, had postdose immunogenicity measurement \& no major PDs, comparisons based on ratios of IgG GMC post booster to IgG GMC post primary series. Comparison done using ratios of the ratios for the 2 treatment groups (PNEUMOSIL ratio/Synflorix ratio), \& corresponding 95% CIs.
Comparison of Serotype-specific booster responses (antibody concentrations) measured by ELISA from 4 weeks after a 3-dose primary series to 4 weeks after a booster dose
Outcome measures
| Measure |
Lot 1
n=436 Participants
Three doses of Pneumosil Lot 1
|
Lot 2
n=425 Participants
Three doses of Pneumosil Lot 2
|
Lot 3
n=216 Participants
Three doses of Pneumosil Lot 3
|
4 Weeks Post Booster-Synflorix
n=209 Participants
Three doses + 1 booster dose of Synflorix in a subset
|
|---|---|---|---|---|
|
Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose
Pn IgG Type 19A
|
1.50 µg/mL
Interval 1.37 to 1.64
|
3.97 µg/mL
Interval 3.63 to 4.33
|
0.26 µg/mL
Interval 0.23 to 0.31
|
0.95 µg/mL
Interval 0.79 to 1.15
|
|
Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose
Pn IgG Type 1
|
4.05 µg/mL
Interval 3.76 to 4.36
|
5.71 µg/mL
Interval 5.25 to 6.21
|
2.12 µg/mL
Interval 1.88 to 2.38
|
2.47 µg/mL
Interval 2.19 to 2.8
|
|
Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose
Pn IgG Type 5
|
1.49 µg/mL
Interval 1.39 to 1.59
|
1.31 µg/mL
Interval 1.21 to 1.41
|
1.26 µg/mL
Interval 1.14 to 1.38
|
0.84 µg/mL
Interval 0.76 to 0.93
|
|
Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose
Pn IgG Type 6A
|
1.09 µg/mL
Interval 0.98 to 1.22
|
4.86 µg/mL
Interval 4.4 to 5.38
|
0.12 µg/mL
Interval 0.11 to 0.14
|
0.42 µg/mL
Interval 0.36 to 0.5
|
|
Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose
Pn IgG Type 6B
|
1.29 µg/mL
Interval 1.13 to 1.48
|
8.32 µg/mL
Interval 7.7 to 8.99
|
1.15 µg/mL
Interval 0.94 to 1.41
|
4.44 µg/mL
Interval 4.0 to 4.93
|
|
Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose
Pn IgG Type 7F
|
3.12 µg/mL
Interval 2.89 to 3.37
|
6.36 µg/mL
Interval 5.87 to 6.89
|
2.49 µg/mL
Interval 2.22 to 2.79
|
4.07 µg/mL
Interval 3.67 to 4.52
|
|
Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose
Pn IgG Type 9V
|
1.29 µg/mL
Interval 1.2 to 1.39
|
1.80 µg/mL
Interval 1.67 to 1.94
|
1.43 µg/mL
Interval 1.28 to 1.6
|
2.08 µg/mL
Interval 1.87 to 2.31
|
|
Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose
Pn IgG Type 14
|
5.06 µg/mL
Interval 4.57 to 5.62
|
6.84 µg/mL
Interval 6.08 to 7.68
|
3.86 µg/mL
Interval 3.25 to 4.57
|
4.67 µg/mL
Interval 2.92 to 5.55
|
|
Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose
Pn IgG Type 19F
|
4.16 µg/mL
Interval 3.85 to 4.48
|
6.18 µg/mL
Interval 5.7 to 6.71
|
6.31 µg/mL
Interval 5.51 to 7.24
|
9.79 µg/mL
Interval 8.77 to 10.92
|
|
Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose
Pn IgG Type 23F
|
1.65 µg/mL
Interval 1.5 to 1.8
|
4.11 µg/mL
Interval 3.75 to 4.5
|
0.94 µg/mL
Interval 0.8 to 1.11
|
2.15 µg/mL
Interval 1.9 to 2.44
|
SECONDARY outcome
Timeframe: 4 weeks post booster vaccinationPopulation: In a subset of subjects who got 3 primary series and a booster dose of study vaccines, had postdose immunogenicity measurement(s) with no major protocol deviations, serotype-specific GMC of IgG Antibody and treatment group ratios of IgG GMCs (with corresponding 95% CIs) were evaluated. Pooled PNEUMOSIL data was used for this analysis as per SAP
Comparison of Serotype-specific booster responses (antibody concentrations) to PNEUMOSIL in comparison to Synflorix 4 weeks after a booster dose
Outcome measures
| Measure |
Lot 1
n=425 Participants
Three doses of Pneumosil Lot 1
|
Lot 2
n=209 Participants
Three doses of Pneumosil Lot 2
|
Lot 3
Three doses of Pneumosil Lot 3
|
4 Weeks Post Booster-Synflorix
Three doses + 1 booster dose of Synflorix in a subset
|
|---|---|---|---|---|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose
Pn IgG Type 1
|
5.73 µg/mL
Interval 5.27 to 6.22
|
2.45 µg/mL
Interval 2.16 to 2.78
|
—
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose
Pn IgG Type 5
|
1.31 µg/mL
Interval 1.21 to 1.41
|
0.83 µg/mL
Interval 0.75 to 0.92
|
—
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose
Pn IgG Type 6A
|
4.87 µg/mL
Interval 4.41 to 5.39
|
0.42 µg/mL
Interval 0.35 to 0.49
|
—
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose
Pn IgG Type 6B
|
8.33 µg/mL
Interval 7.71 to 9.0
|
4.42 µg/mL
Interval 3.98 to 4.9
|
—
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose
Pn IgG Type 7F
|
6.37 µg/mL
Interval 5.88 to 6.9
|
4.06 µg/mL
Interval 3.65 to 4.5
|
—
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose
Pn IgG Type 9V
|
1.81 µg/mL
Interval 1.67 to 1.95
|
2.07 µg/mL
Interval 1.87 to 2.3
|
—
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose
Pn IgG Type 14
|
6.85 µg/mL
Interval 6.09 to 7.7
|
4.62 µg/mL
Interval 3.88 to 5.5
|
—
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose
Pn IgG Type 19A
|
3.97 µg/mL
Interval 3.64 to 4.34
|
0.94 µg/mL
Interval 0.78 to 1.14
|
—
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose
Pn IgG Type 19F
|
6.16 µg/mL
Interval 5.68 to 6.68
|
9.70 µg/mL
Interval 8.68 to 10.83
|
—
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose
Pn IgG Type 23F
|
4.08 µg/mL
Interval 3.72 to 4.47
|
2.13 µg/mL
Interval 1.88 to 2.42
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks post booster vaccinationPopulation: In a subset who got 3 primary series+booster dose of study vaccines, had postdose immunogenicity measurement \& no major PDs, comparisons based on ratios of OPA GMT post booster to OPA GMT post primary series. Comparison done using ratios of the ratios for the 2 treatment groups (PNEUMOSIL ratio/Synflorix ratio), \& corresponding 95% CIs.
Comparison of Serotype-specific booster responses (functional response-OPA) from 4 weeks after a 3-dose primary series to 4 weeks after a booster dose
Outcome measures
| Measure |
Lot 1
n=239 Participants
Three doses of Pneumosil Lot 1
|
Lot 2
n=99 Participants
Three doses of Pneumosil Lot 2
|
Lot 3
n=214 Participants
Three doses of Pneumosil Lot 3
|
4 Weeks Post Booster-Synflorix
n=100 Participants
Three doses + 1 booster dose of Synflorix in a subset
|
|---|---|---|---|---|
|
Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose
OPA Type 1
|
99.21 titer
Interval 75.22 to 130.9
|
344.5 titer
Interval 261.8 to 453.5
|
29.76 titer
Interval 21.73 to 40.78
|
187.2 titer
Interval 141.6 to 247.4
|
|
Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose
OPA Type 5
|
161.2 titer
Interval 126.8 to 205.0
|
409.9 titer
Interval 312.4 to 537.8
|
112.9 titer
Interval 86.79 to 146.9
|
360.6 titer
Interval 281.9 to 461.2
|
|
Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose
OPA Type 6A
|
1225 titer
Interval 900.0 to 1666.0
|
3063 titer
Interval 2329.0 to 4030.0
|
6.44 titer
Interval 4.8 to 8.64
|
39.96 titer
Interval 22.94 to 69.59
|
|
Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose
OPA Type 6B
|
771.4 titer
Interval 527.2 to 1129.0
|
2897 titer
Interval 2259.0 to 3714.0
|
495.2 titer
Interval 339.6 to 722.1
|
1610 titer
Interval 1271.0 to 2040.0
|
|
Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose
OPA Type 7F
|
1795 titer
Interval 1461.0 to 2205.0
|
6977 titer
Interval 5602.0 to 8691.0
|
1438 titer
Interval 1136.0 to 1820.0
|
4036 titer
Interval 3270.0 to 4981.0
|
|
Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose
OPA Type 9V
|
168.7 titer
Interval 117.4 to 242.4
|
1155 titer
Interval 871.4 to 1530.0
|
417.0 titer
Interval 323.3 to 537.8
|
1229 titer
Interval 979.3 to 1542.0
|
|
Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose
OPA Type 14
|
1254 titer
Interval 885.8 to 1776.0
|
3069 titer
Interval 2287.0 to 4118.0
|
866.8 titer
Interval 579.6 to 1296.0
|
1401 titer
Interval 967.4 to 2029.0
|
|
Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose
OPA Type 19A
|
177.5 titer
Interval 131.0 to 240.5
|
645.6 titer
Interval 489.7 to 851.0
|
8.89 titer
Interval 6.81 to 11.6
|
53.15 titer
Interval 33.24 to 84.99
|
|
Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose
OPA Type 19F
|
669.9 titer
Interval 533.6 to 841.2
|
1592 titer
Interval 1256.0 to 2019.0
|
801.0 titer
Interval 624.1 to 1028.0
|
1580 titer
Interval 1190.0 to 2099.0
|
|
Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose
OPA Type 23F
|
774.5 titer
Interval 588.3 to 1020.0
|
3847 titer
Interval 2962.0 to 4996.0
|
211.7 titer
Interval 142.0 to 315.7
|
1213 titer
Interval 945.7 to 1557.0
|
SECONDARY outcome
Timeframe: 4 weeks post booster vaccinationPopulation: In a subset of subjects who got 3 primary series and a booster dose of study vaccines, had postdose immunogenicity measurement(s) with no major protocol deviations, serotype-specific OPA GMT and treatment group ratios of OPA GMT (with corresponding 95% CIs) were evaluated. Pooled PNEUMOSIL data was used for this analysis as per SAP
Comparison of Serotype-specific booster responses (functional response) to PNEUMOSIL in comparison to Synflorix 4 weeks after a booster dose
Outcome measures
| Measure |
Lot 1
n=99 Participants
Three doses of Pneumosil Lot 1
|
Lot 2
n=100 Participants
Three doses of Pneumosil Lot 2
|
Lot 3
Three doses of Pneumosil Lot 3
|
4 Weeks Post Booster-Synflorix
Three doses + 1 booster dose of Synflorix in a subset
|
|---|---|---|---|---|
|
Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose
OPA Type 1
|
344.53 titer
Interval 261.77 to 453.46
|
187.16 titer
Interval 141.59 to 247.4
|
—
|
—
|
|
Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose
OPA Type 5
|
409.87 titer
Interval 312.35 to 537.84
|
360.59 titer
Interval 281.89 to 461.25
|
—
|
—
|
|
Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose
OPA Type 6A
|
3063.37 titer
Interval 2328.56 to 4030.06
|
44.98 titer
Interval 25.86 to 78.25
|
—
|
—
|
|
Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose
OPA Type 6B
|
2824.56 titer
Interval 2207.88 to 3613.5
|
1610.81 titer
Interval 1276.29 to 2033.01
|
—
|
—
|
|
Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose
OPA Type 7F
|
6977.27 titer
Interval 5601.56 to 8690.85
|
4036.08 titer
Interval 3270.2 to 4981.32
|
—
|
—
|
|
Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose
OPA Type 9V
|
1137.28 titer
Interval 862.3 to 1499.94
|
1229.05 titer
Interval 979.3 to 1542.5
|
—
|
—
|
|
Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose
OPA Type 14
|
3114.71 titer
Interval 2331.38 to 4161.22
|
1411.94 titer
Interval 978.24 to 2037.92
|
—
|
—
|
|
Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose
OPA Type 19A
|
645.56 titer
Interval 489.69 to 851.04
|
51.47 titer
Interval 32.4 to 81.76
|
—
|
—
|
|
Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose
OPA Type 19F
|
1592.40 titer
Interval 1255.72 to 2019.35
|
1580.46 titer
Interval 1189.81 to 2099.38
|
—
|
—
|
|
Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose
OPA Type 23F
|
3846.82 titer
Interval 2962.23 to 4995.58
|
1226.89 titer
Interval 967.91 to 1555.18
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks post booster vaccinationPopulation: Evaluated in a subset who got 3 primary doses and a booster dose, had postdose immunogenicity data with no major protocol deviations. Non-inferiority shown if 2-sided 95% CI for difference in response proportions (PNEUMOSIL-Synflorix) had lower limit \>-0.10. For this, pooled PNUEMOSIL data was used as specified in SAP.
Anti-measles IgG, anti-rubella IgG and anti-yellow fever neutralizing antibody titer
Outcome measures
| Measure |
Lot 1
n=425 Participants
Three doses of Pneumosil Lot 1
|
Lot 2
n=208 Participants
Three doses of Pneumosil Lot 2
|
Lot 3
Three doses of Pneumosil Lot 3
|
4 Weeks Post Booster-Synflorix
Three doses + 1 booster dose of Synflorix in a subset
|
|---|---|---|---|---|
|
Number and Percentage of Subjects With EPI Vaccine Immune Responses (Measles, Rubella and Yellow Fever)
Anti-Measles IgG ≥ 150 mIU/mL
|
381 Participants
|
183 Participants
|
—
|
—
|
|
Number and Percentage of Subjects With EPI Vaccine Immune Responses (Measles, Rubella and Yellow Fever)
Anti- Rubella IgG ≥ 4 IU/mL
|
421 Participants
|
204 Participants
|
—
|
—
|
|
Number and Percentage of Subjects With EPI Vaccine Immune Responses (Measles, Rubella and Yellow Fever)
Anti-Yellow Fever neutralizing Ab titer ≥ 1:8
|
420 Participants
|
201 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: One Year Post Booster VaccinationPopulation: In a subset of subjects who got 3 primary and a booster dose of study vaccines, had postdose immunogenicity measurement(s) one year post booster with no major protocol deviations, serotype-specific IgG responders and treatment group comparisons (with corresponding 95% CIs) were evaluated. Pooled PNEUMOSIL data was used for this analysis as per SAP
Treatment group proportions and treatment-group difference in proportions of IgG responders (IgG concentration ≥ 0.35 μg/mL)
Outcome measures
| Measure |
Lot 1
n=378 Participants
Three doses of Pneumosil Lot 1
|
Lot 2
n=190 Participants
Three doses of Pneumosil Lot 2
|
Lot 3
Three doses of Pneumosil Lot 3
|
4 Weeks Post Booster-Synflorix
Three doses + 1 booster dose of Synflorix in a subset
|
|---|---|---|---|---|
|
Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster
Pn IgG Type 7F
|
296 Participants
|
117 Participants
|
—
|
—
|
|
Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster
Pn IgG Type 9V
|
209 Participants
|
106 Participants
|
—
|
—
|
|
Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster
Pn IgG Type 14
|
322 Participants
|
134 Participants
|
—
|
—
|
|
Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster
Pn IgG Type 19A
|
316 Participants
|
128 Participants
|
—
|
—
|
|
Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster
Pn IgG Type 1
|
150 Participants
|
44 Participants
|
—
|
—
|
|
Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster
Pn IgG Type 5
|
223 Participants
|
99 Participants
|
—
|
—
|
|
Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster
Pn IgG Type 6A
|
306 Participants
|
97 Participants
|
—
|
—
|
|
Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster
Pn IgG Type 6B
|
344 Participants
|
143 Participants
|
—
|
—
|
|
Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster
Pn IgG Type 19F
|
301 Participants
|
174 Participants
|
—
|
—
|
|
Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster
Pn IgG Type 23F
|
224 Participants
|
79 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: One year post booster vaccinationPopulation: Subset of subjects who got 3 primary and a booster dose of study vaccines, had postdose immunogenicity measurement(s) one year post booster with no major protocol deviations, serotype-specific GMC of IgG Antibody and treatment group ratios of IgG GMCs (with corresponding 95% CIs) evaluated. Pooled PNEUMOSIL data was used for this analysis
Comparison of Serotype-specific immune persistence responses (antibody concentrations) to PNEUMOSIL in comparison to Synflorix one year post booster
Outcome measures
| Measure |
Lot 1
n=378 Participants
Three doses of Pneumosil Lot 1
|
Lot 2
n=190 Participants
Three doses of Pneumosil Lot 2
|
Lot 3
Three doses of Pneumosil Lot 3
|
4 Weeks Post Booster-Synflorix
Three doses + 1 booster dose of Synflorix in a subset
|
|---|---|---|---|---|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios One Year Post Booster
Pn IgG Type 1
|
0.30 µg/mL
Interval 0.28 to 0.32
|
0.18 µg/mL
Interval 0.16 to 0.21
|
—
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios One Year Post Booster
Pn IgG Type 5
|
0.40 µg/mL
Interval 0.37 to 0.44
|
0.34 µg/mL
Interval 0.29 to 0.39
|
—
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios One Year Post Booster
Pn IgG Type 6A
|
0.73 µg/mL
Interval 0.67 to 0.8
|
0.31 µg/mL
Interval 0.26 to 0.36
|
—
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios One Year Post Booster
Pn IgG Type 6B
|
0.90 µg/mL
Interval 0.84 to 0.97
|
0.62 µg/mL
Interval 0.55 to 0.71
|
—
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios One Year Post Booster
Pn IgG Type 7F
|
0.64 µg/mL
Interval 0.59 to 0.69
|
0.49 µg/mL
Interval 0.44 to 0.55
|
—
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios One Year Post Booster
Pn IgG Type 9V
|
0.38 µg/mL
Interval 0.35 to 0.42
|
0.41 µg/mL
Interval 0.36 to 0.46
|
—
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios One Year Post Booster
Pn IgG Type 14
|
0.99 µg/mL
Interval 0.89 to 1.1
|
0.71 µg/mL
Interval 0.59 to 0.85
|
—
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios One Year Post Booster
Pn IgG Type 19A
|
0.91 µg/mL
Interval 0.81 to 1.01
|
0.66 µg/mL
Interval 0.55 to 0.78
|
—
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios One Year Post Booster
Pn IgG Type 19F
|
0.82 µg/mL
Interval 0.73 to 0.92
|
1.35 µg/mL
Interval 1.17 to 1.55
|
—
|
—
|
|
Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios One Year Post Booster
Pn IgG Type 23F
|
0.43 µg/mL
Interval 0.39 to 0.48
|
0.29 µg/mL
Interval 0.25 to 0.34
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: One year post booster vaccinationPopulation: Subset who got 3 primary series+booster dose of study vaccines, had postdose immunogenicity measurements post booster, no major PDs, comparisons based on ratios of IgG GMC one year post booster to IgG GMC four weeks post booster. Comparison done using ratios of the ratios for the 2 treatment groups \& corresponding 95% CIs.
Comparison of Serotype-specific responses (antibody concentrations) measured by ELISA from 4 weeks after a booster dose to one year after a booster dose
Outcome measures
| Measure |
Lot 1
n=378 Participants
Three doses of Pneumosil Lot 1
|
Lot 2
n=378 Participants
Three doses of Pneumosil Lot 2
|
Lot 3
n=189 Participants
Three doses of Pneumosil Lot 3
|
4 Weeks Post Booster-Synflorix
n=190 Participants
Three doses + 1 booster dose of Synflorix in a subset
|
|---|---|---|---|---|
|
Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a Booster Dose to One Year After a Booster Dose
Pn IgG Type 23F
|
4.03 µg/mL
Interval 3.66 to 4.45
|
0.43 µg/mL
Interval 0.39 to 0.48
|
2.12 µg/mL
Interval 1.86 to 2.42
|
0.29 µg/mL
Interval 0.25 to 0.34
|
|
Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a Booster Dose to One Year After a Booster Dose
Pn IgG Type 1
|
5.87 µg/mL
Interval 5.36 to 6.42
|
0.30 µg/mL
Interval 0.28 to 0.32
|
2.52 µg/mL
Interval 2.21 to 2.88
|
0.18 µg/mL
Interval 0.16 to 0.21
|
|
Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a Booster Dose to One Year After a Booster Dose
Pn IgG Type 5
|
1.35 µg/mL
Interval 1.24 to 1.46
|
0.40 µg/mL
Interval 0.37 to 0.44
|
0.85 µg/mL
Interval 0.77 to 0.95
|
0.34 µg/mL
Interval 0.29 to 0.39
|
|
Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a Booster Dose to One Year After a Booster Dose
Pn IgG Type 6A
|
4.86 µg/mL
Interval 4.37 to 5.41
|
0.73 µg/mL
Interval 0.67 to 0.8
|
0.43 µg/mL
Interval 0.36 to 0.51
|
0.31 µg/mL
Interval 0.26 to 0.36
|
|
Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a Booster Dose to One Year After a Booster Dose
Pn IgG Type 6B
|
8.48 µg/mL
Interval 7.84 to 9.18
|
0.90 µg/mL
Interval 0.84 to 0.97
|
4.45 µg/mL
Interval 3.99 to 4.97
|
0.62 µg/mL
Interval 0.55 to 0.71
|
|
Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a Booster Dose to One Year After a Booster Dose
Pn IgG Type 7F
|
6.40 µg/mL
Interval 5.87 to 6.97
|
0.64 µg/mL
Interval 0.59 to 0.69
|
4.14 µg/mL
Interval 3.72 to 4.6
|
0.49 µg/mL
Interval 0.44 to 0.55
|
|
Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a Booster Dose to One Year After a Booster Dose
Pn IgG Type 9V
|
1.86 µg/mL
Interval 1.72 to 2.01
|
0.38 µg/mL
Interval 0.35 to 0.42
|
2.08 µg/mL
Interval 1.87 to 2.32
|
0.41 µg/mL
Interval 0.36 to 0.46
|
|
Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a Booster Dose to One Year After a Booster Dose
Pn IgG Type 14
|
6.58 µg/mL
Interval 5.8 to 7.46
|
0.99 µg/mL
Interval 0.89 to 1.1
|
4.61 µg/mL
Interval 3.83 to 5.56
|
0.71 µg/mL
Interval 0.59 to 0.85
|
|
Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a Booster Dose to One Year After a Booster Dose
Pn IgG Type 19A
|
4.02 µg/mL
Interval 3.66 to 4.42
|
0.91 µg/mL
Interval 0.81 to 1.01
|
1.00 µg/mL
Interval 0.82 to 1.22
|
0.66 µg/mL
Interval 0.55 to 0.78
|
|
Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a Booster Dose to One Year After a Booster Dose
Pn IgG Type 19F
|
6.17 µg/mL
Interval 5.65 to 6.73
|
0.82 µg/mL
Interval 0.73 to 0.92
|
9.80 µg/mL
Interval 8.72 to 11.02
|
1.35 µg/mL
Interval 1.17 to 1.55
|
OTHER_PRE_SPECIFIED outcome
Timeframe: One year post booster vaccinationPopulation: Subset of subjects who got 3 primary doses + booster dose, had postdose immunogenicity measurement one year after booster, no major protocol deviations, functional immune responses induced by PNEUMOSIL were compared to Synflorix for 10 serotypes OPA Type 1\[OPA seroresponse rate (titer≥1:8)\] differences.Pooled PNEUMOSIL data was used.
Serotype-specific functional antibody titer measured by OPA
Outcome measures
| Measure |
Lot 1
n=50 Participants
Three doses of Pneumosil Lot 1
|
Lot 2
n=50 Participants
Three doses of Pneumosil Lot 2
|
Lot 3
Three doses of Pneumosil Lot 3
|
4 Weeks Post Booster-Synflorix
Three doses + 1 booster dose of Synflorix in a subset
|
|---|---|---|---|---|
|
Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster
OPA Type 1
|
27 Participants
|
14 Participants
|
—
|
—
|
|
Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster
OPA Type 5
|
39 Participants
|
37 Participants
|
—
|
—
|
|
Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster
OPA Type 6A
|
42 Participants
|
9 Participants
|
—
|
—
|
|
Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster
OPA Type 6B
|
43 Participants
|
31 Participants
|
—
|
—
|
|
Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster
OPA Type 7F
|
50 Participants
|
48 Participants
|
—
|
—
|
|
Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster
OPA Type 9V
|
43 Participants
|
40 Participants
|
—
|
—
|
|
Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster
OPA Type 14
|
45 Participants
|
41 Participants
|
—
|
—
|
|
Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster
OPA Type 19A
|
43 Participants
|
24 Participants
|
—
|
—
|
|
Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster
OPA Type 19F
|
44 Participants
|
39 Participants
|
—
|
—
|
|
Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster
OPA Type 23F
|
49 Participants
|
43 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: One year post booster vaccinationPopulation: In a subset of subjects who got 3 primary + booster dose of study vaccines, had postdose immunogenicity measurement one year post booster and no major protocol deviations, functional immune responses induced by PNEUMOSIL were compared to Synflorix for 10 serotypes, i.e., ratio of OPA GMTs (and corresponding 95% CIs).Pooled PNEUMOSIL data was used.
Serotype-specific functional antibody titer measured by OPA and expressed as OPA GMT in a subset one year post booster
Outcome measures
| Measure |
Lot 1
n=50 Participants
Three doses of Pneumosil Lot 1
|
Lot 2
n=50 Participants
Three doses of Pneumosil Lot 2
|
Lot 3
Three doses of Pneumosil Lot 3
|
4 Weeks Post Booster-Synflorix
Three doses + 1 booster dose of Synflorix in a subset
|
|---|---|---|---|---|
|
Serotype-specific OPA Geometric Mean Titer One Year Post Booster
OPA Type 5
|
41.4 Titer
Interval 27.6 to 62.0
|
31.6 Titer
Interval 20.0 to 50.1
|
—
|
—
|
|
Serotype-specific OPA Geometric Mean Titer One Year Post Booster
OPA Type 6A
|
118.1 Titer
Interval 61.6 to 226.5
|
8.3 Titer
Interval 5.0 to 13.6
|
—
|
—
|
|
Serotype-specific OPA Geometric Mean Titer One Year Post Booster
OPA Type 1
|
11.0 Titer
Interval 8.0 to 15.1
|
8.7 Titer
Interval 5.9 to 12.9
|
—
|
—
|
|
Serotype-specific OPA Geometric Mean Titer One Year Post Booster
OPA Type 6B
|
116.3 Titer
Interval 74.9 to 180.6
|
31.1 Titer
Interval 20.5 to 47.2
|
—
|
—
|
|
Serotype-specific OPA Geometric Mean Titer One Year Post Booster
OPA Type 7F
|
1765.9 Titer
Interval 1238.1 to 2518.8
|
1851.8 Titer
Interval 1251.3 to 2740.5
|
—
|
—
|
|
Serotype-specific OPA Geometric Mean Titer One Year Post Booster
OPA Type 9V
|
114.5 Titer
Interval 63.8 to 205.5
|
158.2 Titer
Interval 86.3 to 289.9
|
—
|
—
|
|
Serotype-specific OPA Geometric Mean Titer One Year Post Booster
OPA Type 14
|
215.1 Titer
Interval 126.2 to 366.6
|
193.4 Titer
Interval 107.9 to 346.6
|
—
|
—
|
|
Serotype-specific OPA Geometric Mean Titer One Year Post Booster
OPA Type 19A
|
89.7 Titer
Interval 50.2 to 160.3
|
17.6 Titer
Interval 11.0 to 28.3
|
—
|
—
|
|
Serotype-specific OPA Geometric Mean Titer One Year Post Booster
OPA Type 19F
|
133.5 Titer
Interval 68.2 to 261.1
|
139.8 Titer
Interval 78.3 to 249.8
|
—
|
—
|
|
Serotype-specific OPA Geometric Mean Titer One Year Post Booster
OPA Type 23F
|
393.8 Titer
Interval 219.3 to 707.4
|
91.6 Titer
Interval 54.0 to 155.3
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: One year post booster vaccinationPopulation: In a subset who got 3 primary series+booster dose of study vaccines, had postdose immunogenicity measurements \& no major PDs, comparisons based on ratios of OPA GMT one year post booster to OPA GMT 4 weeks post booster. Comparison done using ratios of the ratios for the 2 treatment groups (PNEUMOSIL ratio/Synflorix ratio), \& corresponding 95% CIs.
Comparison of Serotype-specific booster responses (functional response-OPA) from 4 weeks after a booster dose to one year post booster
Outcome measures
| Measure |
Lot 1
n=88 Participants
Three doses of Pneumosil Lot 1
|
Lot 2
n=50 Participants
Three doses of Pneumosil Lot 2
|
Lot 3
n=91 Participants
Three doses of Pneumosil Lot 3
|
4 Weeks Post Booster-Synflorix
n=50 Participants
Three doses + 1 booster dose of Synflorix in a subset
|
|---|---|---|---|---|
|
Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose
OPA Type 19F
|
1651.1 Titer
Interval 1282.4 to 2125.8
|
133.5 Titer
Interval 68.2 to 261.1
|
1611.8 Titer
Interval 1227.5 to 2116.4
|
139.8 Titer
Interval 78.3 to 249.8
|
|
Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose
OPA Type 1
|
345.8 Titer
Interval 256.7 to 465.9
|
11.0 Titer
Interval 8.0 to 15.1
|
191.7 Titer
Interval 144.8 to 253.7
|
8.7 Titer
Interval 5.9 to 12.9
|
|
Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose
OPA Type 5
|
422.9 Titer
Interval 315.4 to 567.1
|
41.4 Titer
Interval 27.6 to 62.0
|
369.6 Titer
Interval 289.0 to 472.8
|
31.6 Titer
Interval 20.0 to 50.1
|
|
Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose
OPA Type 6A
|
3119.4 Titer
Interval 2313.3 to 4206.5
|
118.1 Titer
Interval 61.6 to 226.5
|
49.9 Titer
Interval 27.9 to 89.3
|
8.3 Titer
Interval 5.0 to 13.6
|
|
Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose
OPA Type 6B
|
3012.0 Titer
Interval 2309.2 to 3928.6
|
116.3 Titer
Interval 74.9 to 180.6
|
1613.8 Titer
Interval 1258.1 to 2070.1
|
31.1 Titer
Interval 20.5 to 47.2
|
|
Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose
OPA Type 7F
|
6757.8 Titer
Interval 5305.8 to 8607.2
|
1765.9 Titer
Interval 1238.1 to 2518.8
|
4033.5 Titer
Interval 3251.2 to 5004.1
|
1851.8 Titer
Interval 1251.3 to 2740.5
|
|
Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose
OPA Type 9V
|
1114.9 Titer
Interval 828.6 to 1500.2
|
114.5 Titer
Interval 63.8 to 205.5
|
1231.4 Titer
Interval 966.5 to 1568.9
|
158.2 Titer
Interval 86.3 to 289.9
|
|
Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose
OPA Type 14
|
3128.9 Titer
Interval 2279.9 to 4294.0
|
215.1 Titer
Interval 126.2 to 366.6
|
1423.1 Titer
Interval 962.7 to 2103.8
|
193.4 Titer
Interval 107.9 to 346.6
|
|
Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose
OPA Type 19A
|
643.6 Titer
Interval 479.0 to 864.9
|
89.7 Titer
Interval 50.2 to 160.3
|
54.6 Titer
Interval 34.1 to 87.4
|
17.6 Titer
Interval 11.0 to 28.3
|
|
Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose
OPA Type 23F
|
3933.9 Titer
Interval 2961.7 to 5225.1
|
393.8 Titer
Interval 219.3 to 707.4
|
1219.8 Titer
Interval 946.8 to 1571.5
|
91.6 Titer
Interval 54.0 to 155.3
|
Adverse Events
Pneumosil
Serious events: 51 serious events
Other events: 1131 other events
Deaths: 1 deaths
Synflorix
Serious events: 26 serious events
Other events: 572 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Pneumosil
n=1503 participants at risk
Three doses of Pneumosil in primary series cohort and three + 1 booster dose in booster cohort
|
Synflorix
n=747 participants at risk
Three doses of Synflorix in primary series cohort and three + 1 booster dose in booster cohort
|
|---|---|---|
|
Infections and infestations
Bronchiolitis
|
0.93%
14/1503 • Number of events 14 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
0.54%
4/747 • Number of events 4 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Infections and infestations
Gastroenteritis
|
1.00%
15/1503 • Number of events 17 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
1.2%
9/747 • Number of events 9 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Infections and infestations
Pneumonia
|
0.27%
4/1503 • Number of events 4 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
0.80%
6/747 • Number of events 6 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Infections and infestations
Dysentery
|
0.00%
0/1503 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
0.13%
1/747 • Number of events 1 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/1503 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
0.13%
1/747 • Number of events 1 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Infections and infestations
HIV infection WHO clinical stage IV
|
0.00%
0/1503 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
0.13%
1/747 • Number of events 1 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Infections and infestations
Meningitis pneumococcal
|
0.07%
1/1503 • Number of events 1 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
0.00%
0/747 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Infections and infestations
Perinatal HIV infection
|
0.00%
0/1503 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
0.13%
1/747 • Number of events 1 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Infections and infestations
Periorbital cellulitis
|
0.20%
3/1503 • Number of events 3 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
0.13%
1/747 • Number of events 1 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.27%
4/1503 • Number of events 4 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
0.00%
0/747 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Congenital, familial and genetic disorders
Fallot's tetralogy
|
0.07%
1/1503 • Number of events 1 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
0.13%
1/747 • Number of events 1 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Congenital, familial and genetic disorders
Trisomy 21
|
0.13%
2/1503 • Number of events 2 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
0.00%
0/747 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Congenital, familial and genetic disorders
Atrioventricular septal defect
|
0.07%
1/1503 • Number of events 1 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
0.00%
0/747 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Gastrointestinal disorders
Intussusception
|
0.13%
2/1503 • Number of events 2 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
0.00%
0/747 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.07%
1/1503 • Number of events 1 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
0.00%
0/747 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Gastrointestinal disorders
Vomiting
|
0.20%
3/1503 • Number of events 3 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
0.00%
0/747 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
General disorders
Developmental delay
|
0.07%
1/1503 • Number of events 1 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
0.00%
0/747 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/1503 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
0.13%
1/747 • Number of events 1 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Nervous system disorders
Seizure
|
0.07%
1/1503 • Number of events 1 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
0.00%
0/747 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.07%
1/1503 • Number of events 1 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
0.00%
0/747 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.07%
1/1503 • Number of events 1 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
0.00%
0/747 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/1503 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
0.13%
1/747 • Number of events 1 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Infections and infestations
Abscess neck
|
0.00%
0/1503 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
0.13%
1/747 • Number of events 1 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/1503 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
0.13%
1/747 • Number of events 1 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Infections and infestations
Subcutaneous abscess
|
0.07%
1/1503 • Number of events 1 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
0.00%
0/747 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.07%
1/1503 • Number of events 1 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
0.00%
0/747 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
Other adverse events
| Measure |
Pneumosil
n=1503 participants at risk
Three doses of Pneumosil in primary series cohort and three + 1 booster dose in booster cohort
|
Synflorix
n=747 participants at risk
Three doses of Synflorix in primary series cohort and three + 1 booster dose in booster cohort
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
48.6%
730/1503 • Number of events 1041 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
50.7%
379/747 • Number of events 552 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Infections and infestations
Furuncle
|
10.0%
150/1503 • Number of events 183 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
8.7%
65/747 • Number of events 77 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Infections and infestations
Gastroenteritis
|
10.2%
154/1503 • Number of events 169 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
10.2%
76/747 • Number of events 80 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Infections and infestations
Conjunctivitis
|
7.3%
110/1503 • Number of events 116 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
8.6%
64/747 • Number of events 67 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Infections and infestations
Bronchiolitis
|
3.9%
59/1503 • Number of events 65 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
5.6%
42/747 • Number of events 47 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Infections and infestations
Tinea infection
|
4.1%
62/1503 • Number of events 62 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
2.9%
22/747 • Number of events 22 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Infections and infestations
Febrile infection
|
3.5%
52/1503 • Number of events 54 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
3.3%
25/747 • Number of events 28 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Infections and infestations
Pneumonia
|
2.7%
41/1503 • Number of events 44 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
2.8%
21/747 • Number of events 21 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Infections and infestations
Tinea capitis
|
1.9%
29/1503 • Number of events 30 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
2.9%
22/747 • Number of events 23 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Infections and infestations
Oral candidiasis
|
2.2%
33/1503 • Number of events 37 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
2.0%
15/747 • Number of events 15 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Infections and infestations
Body tinea
|
1.9%
29/1503 • Number of events 29 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
2.4%
18/747 • Number of events 18 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Infections and infestations
Impetigo
|
1.8%
27/1503 • Number of events 27 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
2.5%
19/747 • Number of events 19 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Infections and infestations
Rash pustular
|
1.7%
25/1503 • Number of events 26 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
2.1%
16/747 • Number of events 16 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Infections and infestations
Skin candida
|
0.93%
14/1503 • Number of events 14 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
1.5%
11/747 • Number of events 11 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Infections and infestations
Otitis media acute
|
0.40%
6/1503 • Number of events 6 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
1.1%
8/747 • Number of events 8 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Gastrointestinal disorders
Diarrhoea
|
18.7%
281/1503 • Number of events 317 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
17.7%
132/747 • Number of events 139 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
25/1503 • Number of events 25 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
1.7%
13/747 • Number of events 13 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
2.4%
36/1503 • Number of events 37 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
3.7%
28/747 • Number of events 31 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.5%
37/1503 • Number of events 37 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
2.1%
16/747 • Number of events 17 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
1.3%
20/1503 • Number of events 22 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
1.5%
11/747 • Number of events 13 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.1%
17/1503 • Number of events 18 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
0.94%
7/747 • Number of events 7 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.80%
12/1503 • Number of events 12 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
1.5%
11/747 • Number of events 11 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
1.1%
17/1503 • Number of events 17 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
0.67%
5/747 • Number of events 5 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.3%
95/1503 • Number of events 103 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
5.2%
39/747 • Number of events 39 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
General disorders
Pyrexia
|
2.1%
31/1503 • Number of events 31 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
2.1%
16/747 • Number of events 16 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.60%
9/1503 • Number of events 9 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
1.5%
11/747 • Number of events 11 • Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place