Pneumonia, Pneumococcal
Conditions
Brief summary
This study will examine the consistency of 3 batches of the Pneumosil vaccine by looking at the immune response in infants. In addition, the study will compare the immunogenicity of the Pneumosil vaccine to another WHO-prequalified vaccine, Synflorix.
Detailed description
This is a randomized, active-controlled, double-blind, Phase 3 study in 2,250 healthy infants (6 to 8 weeks of age). Subjects will receive 3 doses of either PNEUMOSIL (3 groups receiving vaccine from different lots) or Synflorix (1 group) at 6, 10, and 14 weeks of age. The first 675 randomized subjects will receive a booster dose of either PNEUMOSIL or Synflorix at 9 months of age that matches the treatment assignment for the priming phase. Standard EPI vaccinations in The Gambia will be given concomitantly with all 4 doses of the study vaccines. Out of the 675 booster subjects, subjects who consented for further evaluation will participate for the assessment of immune persistence 12 (+1) months after the booster vaccination The primary objectives are to demonstrate that the three lots of the Pneumosil vaccine is consistent by evaluating the immune responses, and to demonstrate that the immune responses generated by Pneumosil are non-inferior to those generated by Synflorix. The safety and tolerability of Pneumosil will also be evaluated.
Interventions
Sponsors
PATH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 8 Weeks
Healthy volunteers
Yes
Inclusion criteria
* They are healthy infants based on medical history and clinical assessment. * They are between 6 and 8 weeks (ie 42 to 56 days) old, inclusive. * Subject's parent must provide voluntary written/thumb-printed informed consent and be willing to comply with study requirements and procedures.
Exclusion criteria
* Use of any investigational medicinal product prior to randomization. * Previous vaccination against or infection with S. pneumoniae. * History of anaphylactic shock or an allergic reaction to any prior vaccination. * Any fever, illness (including malaria). * Receipt of another vaccine within 30 days of study start. * Chronic administration of an immunosuppressant or administration of immunoglobulins * History of blood disorder, primary immunodeficiency, or a sibling who has such a diagnosis or who died of suddenly without apparent cause. * History of meningitis, seizures or any neurological disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of All SAEs by Severity and Relatedness | 4 weeks post last vaccination | 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 |
| Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | 4 weeks post last vaccination | 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 |
| Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | 7 days (including day of vaccination) | 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 \[life threatening\]. |
| Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | 7 days (including day of vaccination) | 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 \[life threatening\]. |
| Serotype-specific Geometric Mean Concentration of IgG Antibody | 4 weeks after the third dose | Serotype-specific concentrations of immunoglobulin G (IgG) antibody measured by ELISA |
| Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL | 4 weeks after the third dose | Number and Percentage of subjects with serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL |
| Number and Percentage of Subjects With EPI Vaccine Immune Responses (Diphtheria, Tetanus, Hepatitis B, Hib, Polio and Rotavirus) | 4 weeks after the third dose | 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. |
| Anti-pertussis Toxoid GMCs for the Pertussis Antigen | 4 weeks after the third dose | Anti-pertussis toxoid GMCs for the pertussis antigen |
| Anti Fimbriae 2/3 IgG GMCs for the Pertussis Antigen | 4 weeks after the third dose | Anti fimbriae 2/3 IgG GMCs for the pertussis antigen |
| Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | 7 days (including day of vaccination) | 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 \[life threatening\]. |
| Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | 7 days (including day of vaccination) | 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 \[life threatening\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose | 4 weeks post booster vaccination | Comparison of Serotype-specific booster responses (functional response) to PNEUMOSIL in comparison to Synflorix 4 weeks after a booster dose |
| 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 | 4 weeks post booster vaccination | 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 |
| Number and Percentage of Subjects With 6A and 19A Serotype-specific Concentrations of Immunoglobulin G Antibody | 4 weeks after the third dose | Subjects with 6A and 19A serotype-specific concentrations of immunoglobulin G (IgG) antibody measured by ELISA |
| 6A and 19A Serotype Specific Geometric Mean Concentration of IgG Antibody | 4 weeks after the third dose | 6A and 19A Serotype Specific Immune Responses in terms of IgG GMCs measured by ELISA |
| Number and Percentage of Subjects With Functional Antibody Responses | 4 weeks after the third dose | Serotype-specific functional antibody titer measured by OPA |
| Serotype-specific OPA Geometric Mean Titer | 4 weeks after the third dose | Serotype-specific functional antibody titer measured by OPA and expressed as OPA GMT in a subset |
| Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose | 4 weeks post booster vaccination | Comparison of Serotype-specific booster responses (antibody concentrations) to PNEUMOSIL in comparison to Synflorix 4 weeks after a booster dose |
| Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | 4 weeks post booster vaccination | 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 |
| Number and Percentage of Subjects With EPI Vaccine Immune Responses (Measles, Rubella and Yellow Fever) | 4 weeks post booster vaccination | Anti-measles IgG, anti-rubella IgG and anti-yellow fever neutralizing antibody titer |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster | One Year Post Booster Vaccination | Treatment group proportions and treatment-group difference in proportions of IgG responders (IgG concentration ≥ 0.35 μg/mL) |
| Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | One year post booster vaccination | Comparison of Serotype-specific booster responses (functional response-OPA) from 4 weeks after a booster dose to one year post booster |
| Serotype-specific OPA Geometric Mean Titer One Year Post Booster | One year post booster vaccination | Serotype-specific functional antibody titer measured by OPA and expressed as OPA GMT in a subset one year post booster |
| Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster | One year post booster vaccination | Serotype-specific functional antibody titer measured by OPA |
| Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a Booster Dose to One Year After a Booster Dose | One year post booster vaccination | Comparison of Serotype-specific responses (antibody concentrations) measured by ELISA from 4 weeks after a booster dose to one year after a booster dose |
| Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios One Year Post Booster | One year post booster vaccination | Comparison of Serotype-specific immune persistence responses (antibody concentrations) to PNEUMOSIL in comparison to Synflorix one year post booster |
Countries
The Gambia
Participant flow
Recruitment details
Recruitment period: 21 June 2017 to 29 January 2018
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Pneumosil Lot 1 Three doses of Pneumosil Lot 1 | 502 |
| Pneumosil Lot 2 Three doses of Pneumosil Lot 2 | 501 |
| Pneumosil Lot 3 Three doses of Pneumosil Lot 3 | 500 |
| Synflorix Three doses of Synflorix | 747 |
| Total | 2,250 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Immune Persistence Phase | Lost to Follow-up | 0 | 0 | 2 | 1 |
| Immune Persistence Phase | Not vaccine related | 1 | 0 | 1 | 1 |
| Immune Persistence Phase | Withdrawal by subject's parents | 4 | 4 | 2 | 3 |
| Primary and Booster Phase | Adverse Event | 0 | 0 | 0 | 1 |
| Primary and Booster Phase | Death | 1 | 0 | 0 | 2 |
| Primary and Booster Phase | Ineligibility criteria | 1 | 1 | 4 | 2 |
| Primary and Booster Phase | Lost to Follow-up | 0 | 0 | 1 | 0 |
| Primary and Booster Phase | Not vaccine related | 1 | 2 | 0 | 6 |
| Primary and Booster Phase | Physician Decision | 1 | 0 | 1 | 3 |
| Primary and Booster Phase | Withdrawal by subject's parents | 11 | 10 | 14 | 11 |
Baseline characteristics
| Characteristic | Pneumosil Lot 1 | Pneumosil Lot 2 | Pneumosil Lot 3 | Synflorix | Total |
|---|---|---|---|---|---|
| Age, Continuous | 47.0 Days STANDARD_DEVIATION 3.78 | 47.1 Days STANDARD_DEVIATION 4.1 | 47.3 Days STANDARD_DEVIATION 4.03 | 47.1 Days STANDARD_DEVIATION 4.05 | 47.2 Days STANDARD_DEVIATION 4.01 |
| Race/Ethnicity, Customized Ethnicity-Fula | 61 Participants | 63 Participants | 62 Participants | 86 Participants | 272 Participants |
| Race/Ethnicity, Customized Ethnicity-Jola | 63 Participants | 54 Participants | 63 Participants | 100 Participants | 280 Participants |
| Race/Ethnicity, Customized Ethnicity-Mandinka | 264 Participants | 256 Participants | 257 Participants | 397 Participants | 1174 Participants |
| Race/Ethnicity, Customized Ethnicity-Manjago | 8 Participants | 11 Participants | 5 Participants | 11 Participants | 35 Participants |
| Race/Ethnicity, Customized Ethnicity-Other | 26 Participants | 29 Participants | 29 Participants | 42 Participants | 126 Participants |
| Race/Ethnicity, Customized Ethnicity-Serahule | 11 Participants | 16 Participants | 20 Participants | 29 Participants | 76 Participants |
| Race/Ethnicity, Customized Ethnicity-Serere | 21 Participants | 14 Participants | 13 Participants | 21 Participants | 69 Participants |
| Race/Ethnicity, Customized Ethnicity-Wolof | 47 Participants | 58 Participants | 51 Participants | 61 Participants | 217 Participants |
| Race/Ethnicity, Customized Race-African | 502 Participants | 500 Participants | 500 Participants | 747 Participants | 2249 Participants |
| Race/Ethnicity, Customized Race-Other | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Region of Enrollment Gambia | 502 participants | 501 participants | 500 participants | 747 participants | 2250 participants |
| Sex: Female, Male Female | 252 Participants | 241 Participants | 245 Participants | 347 Participants | 1085 Participants |
| Sex: Female, Male Male | 250 Participants | 260 Participants | 255 Participants | 400 Participants | 1165 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 1,503 | 2 / 747 |
| other Total, other adverse events | 1,131 / 1,503 | 572 / 747 |
| serious Total, serious adverse events | 51 / 1,503 | 26 / 747 |
Outcome results
Primary
Anti Fimbriae 2/3 IgG GMCs for the Pertussis Antigen
Anti fimbriae 2/3 IgG GMCs for the pertussis antigen
Time frame: 4 weeks after the third dose
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Lot 1 | Anti Fimbriae 2/3 IgG GMCs for the Pertussis Antigen | 317.97 U/mL |
| Lot 2 | Anti Fimbriae 2/3 IgG GMCs for the Pertussis Antigen | 324.87 U/mL |
95% CI: [0.77, 1.25]
Primary
Anti-pertussis Toxoid GMCs for the Pertussis Antigen
Anti-pertussis toxoid GMCs for the pertussis antigen
Time frame: 4 weeks after the third dose
Population: 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
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Lot 1 | Anti-pertussis Toxoid GMCs for the Pertussis Antigen | 50.95 IU/mL |
| Lot 2 | Anti-pertussis Toxoid GMCs for the Pertussis Antigen | 61.82 IU/mL |
95% CI: [0.62, 1.09]
Primary
Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness
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
Time frame: 4 weeks post last vaccination
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Bronchiolitis | Severe-Related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Bronchiolitis | Severe-Not related | 13 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Bronchiolitis | None | 1440 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Tinea infection | Mild-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Tinea infection | Moderate-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Tinea infection | Severe-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Tinea infection | None | 1441 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Febrile infection | Mild-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Febrile infection | Moderate-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Febrile infection | Severe-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Febrile infection | None | 1450 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Pneumonia | Mild-Related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Pneumonia | Mild-Not related | 17 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Pneumonia | Moderate-Related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Pneumonia | Moderate-Not related | 21 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Pneumonia | Severe-Related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Pneumonia | Severe-Not related | 5 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Pneumonia | None | 1460 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Tinea capitis | Mild-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Tinea capitis | Moderate-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Tinea capitis | Severe-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Tinea capitis | None | 1474 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Oral candidiasis | Mild-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Oral candidiasis | Moderate-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Oral candidiasis | Severe-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Oral candidiasis | None | 1468 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Body tinea | Mild-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Body tinea | Moderate-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Body tinea | Severe-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Body tinea | None | 1474 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Impetigo | Mild-Related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Impetigo | Mild-Not related | 24 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Impetigo | Moderate-Related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Impetigo | Moderate-Not related | 3 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Impetigo | Severe-Related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Impetigo | Severe-Not related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Impetigo | None | 1476 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Rash pustular | Mild-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Rash pustular | Moderate-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Rash pustular | Severe-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Rash pustular | None | 1478 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Skin candida | Mild-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Skin candida | Moderate-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Skin candida | Severe-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Skin candida | None | 1489 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Diarrhoea | Mild-Related | 1 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Diarrhoea | Mild-Not related | 268 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Diarrhoea | Moderate-Related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Diarrhoea | Moderate-Not related | 16 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Diarrhoea | Severe-Related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Diarrhoea | Severe-Not related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Diarrhoea | None | 1218 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Vomiting | Mild-Related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Vomiting | Mild-Not related | 22 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Vomiting | Moderate-Related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Vomiting | Moderate-Not related | 2 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Vomiting | Severe-Related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Vomiting | Severe-Not related | 1 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Vomiting | None | 1478 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis diaper | Mild-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis diaper | Moderate-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis diaper | Severe-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis diaper | None | 1467 Participants |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Rash maculo-papular | None | 1466 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Rash papular | Mild-Related | 1 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Rash papular | Moderate-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Rash papular | Severe-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Rash papular | None | 1483 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis contact | Mild-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis contact | Moderate-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis contact | Severe-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis contact | None | 1485 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis atopic | Mild-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis atopic | Moderate-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis atopic | Severe-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis atopic | None | 1491 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Seborrhoeic dermatitis | Mild-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Seborrhoeic dermatitis | Moderate-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Seborrhoeic dermatitis | Severe-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Seborrhoeic dermatitis | None | 1486 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Cough | Mild-Related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Cough | Mild-Not related | 95 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Cough | Moderate-Related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Cough | Moderate-Not related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Cough | Severe-Related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Cough | Severe-Not related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Cough | None | 1408 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Pyrexia | Mild-Related | 1 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Pyrexia | Mild-Not related | 17 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Pyrexia | Moderate-Related | 1 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Pyrexia | Moderate-Not related | 8 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Pyrexia | Severe-Related | 3 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Pyrexia | Severe-Not related | 1 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Pyrexia | None | 1472 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Thermal burn | Mild-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Thermal burn | Moderate-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Thermal burn | Severe-Related | 0 Participants |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Thermal burn | None | 1494 Participants |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Furuncle | Mild-Related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Furuncle | Mild-Not related | 142 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Furuncle | Moderate-Related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Furuncle | Moderate-Not related | 11 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Furuncle | Severe-Related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Furuncle | Severe-Not related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Furuncle | None | 1350 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Gastroenteritis | Mild-Related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Gastroenteritis | Mild-Not related | 125 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Gastroenteritis | Moderate-Related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Gastroenteritis | Moderate-Not related | 27 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Gastroenteritis | Severe-Related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Gastroenteritis | Severe-Not related | 5 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Gastroenteritis | None | 1346 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Conjunctivitis | Mild-Related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Conjunctivitis | Mild-Not related | 103 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Conjunctivitis | Moderate-Related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Conjunctivitis | Moderate-Not related | 8 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Conjunctivitis | Severe-Related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Conjunctivitis | Severe-Not related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Conjunctivitis | None | 1392 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Bronchiolitis | Mild-Related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Bronchiolitis | Mild-Not related | 30 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Bronchiolitis | Moderate-Related | 0 Participants |
| Lot 1 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Bronchiolitis | Moderate-Not related | 20 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Rash maculo-papular | Mild-Related | 1 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Bronchiolitis | Severe-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Pyrexia | Moderate-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Bronchiolitis | Severe-Not related | 4 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Rash maculo-papular | Mild-Not related | 14 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Bronchiolitis | None | 703 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Furuncle | Moderate-Not related | 3 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Tinea infection | Mild-Related | 0 Participants |
| Lot 2 | 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 |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Tinea infection | Mild-Not related | 21 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Pyrexia | Moderate-Not related | 1 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Tinea infection | Moderate-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Rash maculo-papular | Moderate-Not related | 2 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Tinea infection | Moderate-Not related | 1 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Conjunctivitis | Mild-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Tinea infection | Severe-Related | 0 Participants |
| Lot 2 | 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 |
| Lot 2 | 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 |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Pyrexia | Severe-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Tinea infection | None | 725 Participants |
| Lot 2 | 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 |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Febrile infection | Mild-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Furuncle | Severe-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Febrile infection | Mild-Not related | 20 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Rash maculo-papular | None | 730 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Febrile infection | Moderate-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Pyrexia | Severe-Not related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Febrile infection | Moderate-Not related | 7 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Rash papular | Mild-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Febrile infection | Severe-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Bronchiolitis | Mild-Not related | 32 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Febrile infection | Severe-Not related | 1 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Rash papular | Mild-Not related | 11 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Febrile infection | None | 719 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Pyrexia | None | 731 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Pneumonia | Mild-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Rash papular | Moderate-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Pneumonia | Mild-Not related | 10 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Furuncle | Severe-Not related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Pneumonia | Moderate-Related | 0 Participants |
| Lot 2 | 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 |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Pneumonia | Moderate-Not related | 5 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Thermal burn | Mild-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Pneumonia | Severe-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Rash papular | Severe-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Pneumonia | Severe-Not related | 6 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Conjunctivitis | Mild-Not related | 62 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Pneumonia | None | 726 Participants |
| Lot 2 | 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 |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Tinea capitis | Mild-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Thermal burn | Mild-Not related | 10 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Tinea capitis | Mild-Not related | 22 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Rash papular | None | 736 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Tinea capitis | Moderate-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Furuncle | None | 682 Participants |
| Lot 2 | 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 |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis contact | Mild-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Tinea capitis | Severe-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Thermal burn | Moderate-Related | 0 Participants |
| Lot 2 | 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 |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis contact | Mild-Not related | 7 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Tinea capitis | None | 725 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Conjunctivitis | None | 683 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Oral candidiasis | Mild-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis contact | Moderate-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Oral candidiasis | Mild-Not related | 15 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Thermal burn | Moderate-Not related | 1 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Oral candidiasis | Moderate-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis contact | Moderate-Not related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Oral candidiasis | Moderate-Not related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Gastroenteritis | Mild-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Oral candidiasis | Severe-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis contact | Severe-Related | 0 Participants |
| Lot 2 | 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 |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Thermal burn | Severe-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Oral candidiasis | None | 732 Participants |
| Lot 2 | 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 |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Body tinea | Mild-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Conjunctivitis | Moderate-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Body tinea | Mild-Not related | 18 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis contact | None | 740 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Body tinea | Moderate-Related | 0 Participants |
| Lot 2 | 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 |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Body tinea | Moderate-Not related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis atopic | Mild-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Body tinea | Severe-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Gastroenteritis | Mild-Not related | 67 Participants |
| Lot 2 | 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 |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis atopic | Mild-Not related | 10 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Body tinea | None | 729 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Thermal burn | None | 736 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Impetigo | Mild-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis atopic | Moderate-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Impetigo | Mild-Not related | 19 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Bronchiolitis | Moderate-Not related | 8 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Impetigo | Moderate-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis atopic | Moderate-Not related | 1 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Impetigo | Moderate-Not related | 0 Participants |
| Lot 2 | 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 |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Impetigo | Severe-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis atopic | Severe-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Impetigo | Severe-Not related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Gastroenteritis | Moderate-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Impetigo | None | 728 Participants |
| Lot 2 | 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 |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Rash pustular | Mild-Related | 0 Participants |
| Lot 2 | 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 | 366 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Rash pustular | Mild-Not related | 15 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis atopic | None | 736 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Rash pustular | Moderate-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Conjunctivitis | Moderate-Not related | 2 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Rash pustular | Moderate-Not related | 1 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Seborrhoeic dermatitis | Mild-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Rash pustular | Severe-Related | 0 Participants |
| Lot 2 | 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 |
| Lot 2 | 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 |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Seborrhoeic dermatitis | Mild-Not related | 5 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Rash pustular | None | 731 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Gastroenteritis | Moderate-Not related | 7 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Skin candida | Mild-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Seborrhoeic dermatitis | Moderate-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Skin candida | Mild-Not related | 11 Participants |
| Lot 2 | 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 | 26 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Skin candida | Moderate-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Seborrhoeic dermatitis | Moderate-Not related | 0 Participants |
| Lot 2 | 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 |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Bronchiolitis | Mild-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Skin candida | Severe-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Seborrhoeic dermatitis | Severe-Related | 0 Participants |
| Lot 2 | 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 |
| Lot 2 | 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 |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Skin candida | None | 736 Participants |
| Lot 2 | 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 |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Diarrhoea | Mild-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Gastroenteritis | Severe-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Diarrhoea | Mild-Not related | 130 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Seborrhoeic dermatitis | None | 742 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Diarrhoea | Moderate-Related | 0 Participants |
| Lot 2 | 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 | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Diarrhoea | Moderate-Not related | 3 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Cough | Mild-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Diarrhoea | Severe-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Conjunctivitis | Severe-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Diarrhoea | Severe-Not related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Cough | Mild-Not related | 38 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Diarrhoea | None | 614 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Upper respiratory tract infection | None | 355 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Vomiting | Mild-Related | 1 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Cough | Moderate-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Vomiting | Mild-Not related | 12 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Gastroenteritis | Severe-Not related | 3 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Vomiting | Moderate-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Cough | Moderate-Not related | 1 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Vomiting | Moderate-Not related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Furuncle | Mild-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Vomiting | Severe-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Cough | Severe-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Vomiting | Severe-Not related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Bronchiolitis | Moderate-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Vomiting | None | 734 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Cough | Severe-Not related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis diaper | Mild-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Furuncle | Mild-Not related | 62 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis diaper | Mild-Not related | 27 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Cough | None | 708 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis diaper | Moderate-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Gastroenteritis | None | 670 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis diaper | Moderate-Not related | 1 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Pyrexia | Mild-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis diaper | Severe-Related | 0 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Furuncle | Moderate-Related | 0 Participants |
| Lot 2 | 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 |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Pyrexia | Mild-Not related | 15 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Dermatitis diaper | None | 719 Participants |
| Lot 2 | Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness | Conjunctivitis | Severe-Not related | 0 Participants |
Primary
Number and Percentage of All SAEs by Severity and Relatedness
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
Time frame: 4 weeks post last vaccination
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | HIV infection WHO clinical stage IV | Moderate-Not Related | 0 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Pneumonia | None | 1499 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Bronchiolitis | Moderate-Not Related | 0 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Bronchiolitis | Severe-Not Related | 13 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Bronchiolitis | None | 1490 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Gastroenteritis | Moderate-Not Related | 4 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Gastroenteritis | Severe-Not Related | 5 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Gastroenteritis | None | 1494 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Pneumonia | Moderate-Not Related | 0 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Dysentery | Moderate-Not Related | 0 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Dysentery | Severe-Not Related | 0 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Dysentery | None | 1503 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Febrile infection | Moderate-Not Related | 0 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Febrile infection | Severe-Not Related | 0 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Febrile infection | None | 1503 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Pneumonia | Severe-Not Related | 4 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | HIV infection WHO clinical stage IV | Severe-Not Related | 0 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | HIV infection WHO clinical stage IV | None | 1503 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Meningitis pneumococcal | Moderate-Not Related | 0 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Meningitis pneumococcal | Severe-Not Related | 1 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Meningitis pneumococcal | None | 1502 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Perinatal HIV infection | Moderate-Not Related | 0 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Perinatal HIV infection | Severe-Not Related | 0 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Perinatal HIV infection | None | 1503 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Periorbital cellulitis | Moderate-Not Related | 0 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Periorbital cellulitis | Severe-Not Related | 0 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Periorbital cellulitis | None | 1503 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Upper respiratory tract infection | Moderate-Not Related | 0 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Upper respiratory tract infection | Severe-Not Related | 1 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Upper respiratory tract infection | None | 1502 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Fallot's tetralogy | Moderate-Not Related | 0 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Fallot's tetralogy | Severe-Not Related | 1 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Fallot's tetralogy | None | 1502 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Trisomy 21 | Moderate-Not Related | 0 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Trisomy 21 | Severe-Not Related | 2 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Trisomy 21 | None | 1501 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Atrioventricular septal defect | Moderate-Not Related | 0 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Atrioventricular septal defect | Severe-Not Related | 1 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Atrioventricular septal defect | None | 1502 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Intussusception | Moderate-Not Related | 0 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Intussusception | Severe-Not Related | 2 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Intussusception | None | 1501 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Diarrhoea haemorrhagic | Moderate-Not Related | 0 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Diarrhoea haemorrhagic | Severe-Not Related | 1 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Diarrhoea haemorrhagic | None | 1502 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Vomiting | Moderate-Not Related | 0 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Vomiting | Severe-Not Related | 1 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Vomiting | None | 1502 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Developmental delay | Moderate-Not Related | 0 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Developmental delay | Severe-Not Related | 1 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Developmental delay | None | 1502 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Malnutrition | Moderate-Not Related | 0 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Malnutrition | Severe-Not Related | 0 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Malnutrition | None | 1503 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Seizure | Moderate-Not Related | 0 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Seizure | Severe-Not Related | 1 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Seizure | None | 1502 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Epistaxis | Moderate-Not Related | 0 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Epistaxis | Severe-Not Related | 1 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Epistaxis | None | 1502 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Stevens-Johnson syndrome | Moderate-Not Related | 0 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Stevens-Johnson syndrome | Severe-Not Related | 1 Participants |
| Lot 1 | Number and Percentage of All SAEs by Severity and Relatedness | Stevens-Johnson syndrome | None | 1502 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Fallot's tetralogy | Severe-Not Related | 1 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Pneumonia | Severe-Not Related | 6 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Vomiting | None | 747 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Fallot's tetralogy | None | 746 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Bronchiolitis | Moderate-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Seizure | Severe-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Bronchiolitis | Severe-Not Related | 4 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Trisomy 21 | Moderate-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Bronchiolitis | None | 743 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Developmental delay | Moderate-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Gastroenteritis | Moderate-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Trisomy 21 | Severe-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Gastroenteritis | Severe-Not Related | 3 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Epistaxis | None | 747 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Gastroenteritis | None | 744 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Trisomy 21 | None | 747 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Pneumonia | Moderate-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Pneumonia | None | 741 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Developmental delay | Severe-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Dysentery | Moderate-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Atrioventricular septal defect | Moderate-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Dysentery | Severe-Not Related | 1 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Seizure | None | 747 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Dysentery | None | 746 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Atrioventricular septal defect | Severe-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Febrile infection | Moderate-Not Related | 1 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Developmental delay | None | 747 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Febrile infection | Severe-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Atrioventricular septal defect | None | 747 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Febrile infection | None | 746 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Stevens-Johnson syndrome | Severe-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | HIV infection WHO clinical stage IV | Moderate-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Intussusception | Moderate-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | HIV infection WHO clinical stage IV | Severe-Not Related | 1 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Malnutrition | Moderate-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | HIV infection WHO clinical stage IV | None | 746 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Intussusception | Severe-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Meningitis pneumococcal | Moderate-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Epistaxis | Moderate-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Meningitis pneumococcal | Severe-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Intussusception | None | 747 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Meningitis pneumococcal | None | 747 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Malnutrition | Severe-Not Related | 1 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Perinatal HIV infection | Moderate-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Diarrhoea haemorrhagic | Moderate-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Perinatal HIV infection | Severe-Not Related | 1 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Stevens-Johnson syndrome | Moderate-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Perinatal HIV infection | None | 746 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Diarrhoea haemorrhagic | Severe-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Periorbital cellulitis | Moderate-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Malnutrition | None | 746 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Periorbital cellulitis | Severe-Not Related | 1 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Diarrhoea haemorrhagic | None | 747 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Periorbital cellulitis | None | 746 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Epistaxis | Severe-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Upper respiratory tract infection | Moderate-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Vomiting | Moderate-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Upper respiratory tract infection | Severe-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Seizure | Moderate-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Upper respiratory tract infection | None | 747 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Vomiting | Severe-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Fallot's tetralogy | Moderate-Not Related | 0 Participants |
| Lot 2 | Number and Percentage of All SAEs by Severity and Relatedness | Stevens-Johnson syndrome | None | 747 Participants |
Primary
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster
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 \[life threatening\].
Time frame: 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)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Irritability | Grade 0 | 415 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Temperature | Grade 1 | 14 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Temperature | Grade 2 | 9 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Temperature | Grade 3 | 1 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Cutaneous Rash | Grade 0 | 424 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Cutaneous Rash | Grade 1 | 4 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Cutaneous Rash | Grade 2 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Cutaneous Rash | Grade 3 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Temperature | Grade 0 | 404 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Irritability | Grade 1 | 12 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Irritability | Grade 2 | 1 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Irritability | Grade 3 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Drowsiness | Grade 0 | 418 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Drowsiness | Grade 1 | 9 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Drowsiness | Grade 2 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Drowsiness | Grade 3 | 1 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Decreased Appetite | Grade 0 | 425 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Decreased Appetite | Grade 1 | 2 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Decreased Appetite | Grade 2 | 1 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Decreased Appetite | Grade 3 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Tenderness | Grade 0 | 395 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Tenderness | Grade 1 | 28 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Tenderness | Grade 2 | 5 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Tenderness | Grade 3 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Erythema/Redness | Grade 0 | 428 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Erythema/Redness | Grade 1 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Erythema/Redness | Grade 2 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Erythema/Redness | Grade 3 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Induration/Swelling | Grade 0 | 423 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Induration/Swelling | Grade 1 | 5 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Induration/Swelling | Grade 2 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Induration/Swelling | Grade 3 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Induration/Swelling | Grade 3 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Temperature | Grade 0 | 197 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Decreased Appetite | Grade 0 | 211 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Temperature | Grade 1 | 12 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Erythema/Redness | Grade 0 | 213 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Temperature | Grade 2 | 4 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Decreased Appetite | Grade 1 | 2 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Temperature | Grade 3 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Induration/Swelling | Grade 0 | 209 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Cutaneous Rash | Grade 0 | 211 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Decreased Appetite | Grade 2 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Cutaneous Rash | Grade 1 | 2 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Erythema/Redness | Grade 1 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Cutaneous Rash | Grade 2 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Decreased Appetite | Grade 3 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Cutaneous Rash | Grade 3 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Induration/Swelling | Grade 2 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Irritability | Grade 0 | 207 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Tenderness | Grade 0 | 200 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Irritability | Grade 1 | 6 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Erythema/Redness | Grade 2 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Irritability | Grade 2 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Tenderness | Grade 1 | 9 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Irritability | Grade 3 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Induration/Swelling | Grade 1 | 4 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Drowsiness | Grade 0 | 208 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Tenderness | Grade 2 | 4 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Drowsiness | Grade 1 | 5 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Erythema/Redness | Grade 3 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Drowsiness | Grade 2 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Tenderness | Grade 3 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster | Drowsiness | Grade 3 | 0 Participants |
Primary
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1
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 \[life threatening\].
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Cutaneous Rash | Grade 2 | 1 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Temperature | Grade 0 | 516 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Temperature | Grade 1 | 183 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Temperature | Grade 2 | 52 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Cutaneous Rash | Grade 0 | 731 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Cutaneous Rash | Grade 1 | 19 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Induration/Swelling | Grade 2 | 3 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Irritability | Grade 0 | 619 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Irritability | Grade 1 | 127 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Irritability | Grade 2 | 5 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Drowsiness | Grade 0 | 732 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Drowsiness | Grade 1 | 19 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Drowsiness | Grade 2 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Decreased Appetite | Grade 0 | 728 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Decreased Appetite | Grade 1 | 22 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Decreased Appetite | Grade 2 | 1 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Tenderness | Grade 0 | 539 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Tenderness | Grade 1 | 185 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Tenderness | Grade 2 | 27 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Erythema/Redness | Grade 0 | 736 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Erythema/Redness | Grade 1 | 15 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Erythema/Redness | Grade 2 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Induration/Swelling | Grade 0 | 731 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Induration/Swelling | Grade 1 | 17 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Induration/Swelling | Grade 0 | 345 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Induration/Swelling | Grade 2 | 3 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Drowsiness | Grade 2 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Temperature | Grade 0 | 249 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Tenderness | Grade 2 | 20 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Temperature | Grade 1 | 88 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Decreased Appetite | Grade 0 | 349 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Temperature | Grade 2 | 27 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Erythema/Redness | Grade 2 | 1 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Cutaneous Rash | Grade 0 | 353 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Decreased Appetite | Grade 1 | 12 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Cutaneous Rash | Grade 1 | 10 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Erythema/Redness | Grade 0 | 350 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Cutaneous Rash | Grade 2 | 1 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Decreased Appetite | Grade 2 | 3 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Irritability | Grade 0 | 301 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Induration/Swelling | Grade 1 | 16 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Irritability | Grade 1 | 57 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Tenderness | Grade 0 | 251 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Irritability | Grade 2 | 6 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Erythema/Redness | Grade 1 | 13 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Drowsiness | Grade 0 | 352 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Tenderness | Grade 1 | 93 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1 | Drowsiness | Grade 1 | 12 Participants |
Primary
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2
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 \[life threatening\].
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Temperature | Grade 0 | 590 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Decreased Appetite | Grade 0 | 728 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Irritability | Grade 0 | 646 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Decreased Appetite | Grade 1 | 10 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Cutaneous Rash | Grade 0 | 727 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Decreased Appetite | Grade 2 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Irritability | Grade 1 | 84 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Decreased Appetite | Grade 3 | 1 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Induration/Swelling | Grade 3 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Tenderness | Grade 0 | 585 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Temperature | Grade 2 | 25 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Tenderness | Grade 1 | 127 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Irritability | Grade 2 | 8 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Tenderness | Grade 2 | 27 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Cutaneous Rash | Grade 1 | 10 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Tenderness | Grade 3 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Irritability | Grade 3 | 1 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Erythema/Redness | Grade 0 | 725 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Temperature | Grade 1 | 121 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Erythema/Redness | Grade 1 | 14 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Drowsiness | Grade 0 | 726 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Erythema/Redness | Grade 2 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Cutaneous Rash | Grade 2 | 2 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Erythema/Redness | Grade 3 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Drowsiness | Grade 1 | 13 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Induration/Swelling | Grade 0 | 724 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Temperature | Grade 3 | 3 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Induration/Swelling | Grade 1 | 14 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Drowsiness | Grade 2 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Induration/Swelling | Grade 2 | 1 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Cutaneous Rash | Grade 3 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Drowsiness | Grade 3 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Decreased Appetite | Grade 3 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Temperature | Grade 0 | 271 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Temperature | Grade 1 | 70 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Temperature | Grade 2 | 19 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Temperature | Grade 3 | 1 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Cutaneous Rash | Grade 0 | 355 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Cutaneous Rash | Grade 1 | 4 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Cutaneous Rash | Grade 2 | 1 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Cutaneous Rash | Grade 3 | 1 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Irritability | Grade 0 | 324 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Irritability | Grade 1 | 36 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Irritability | Grade 2 | 1 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Irritability | Grade 3 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Drowsiness | Grade 0 | 359 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Drowsiness | Grade 1 | 2 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Drowsiness | Grade 2 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Drowsiness | Grade 3 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Decreased Appetite | Grade 0 | 354 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Decreased Appetite | Grade 1 | 4 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Decreased Appetite | Grade 2 | 3 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Tenderness | Grade 0 | 283 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Tenderness | Grade 1 | 63 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Tenderness | Grade 2 | 15 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Tenderness | Grade 3 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Erythema/Redness | Grade 0 | 356 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Erythema/Redness | Grade 1 | 5 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Erythema/Redness | Grade 2 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Erythema/Redness | Grade 3 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Induration/Swelling | Grade 0 | 348 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Induration/Swelling | Grade 1 | 11 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Induration/Swelling | Grade 2 | 2 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2 | Induration/Swelling | Grade 3 | 0 Participants |
Primary
Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3
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 \[life threatening\].
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Irritability | Grade 0 | 657 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Temperature | Grade 1 | 122 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Temperature | Grade 2 | 37 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Temperature | Grade 3 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Temperature | Grade 4 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Cutaneous Rash | Grade 0 | 726 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Cutaneous Rash | Grade 1 | 9 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Cutaneous Rash | Grade 2 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Cutaneous Rash | Grade 3 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Cutaneous Rash | Grade 4 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Temperature | Grade 0 | 576 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Irritability | Grade 1 | 74 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Irritability | Grade 2 | 3 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Irritability | Grade 3 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Irritability | Grade 4 | 1 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Drowsiness | Grade 0 | 717 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Drowsiness | Grade 1 | 17 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Drowsiness | Grade 2 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Drowsiness | Grade 3 | 1 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Drowsiness | Grade 4 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Decreased Appetite | Grade 0 | 716 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Decreased Appetite | Grade 1 | 17 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Decreased Appetite | Grade 2 | 1 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Decreased Appetite | Grade 3 | 1 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Decreased Appetite | Grade 4 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Tenderness | Grade 0 | 605 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Tenderness | Grade 1 | 110 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Tenderness | Grade 2 | 20 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Tenderness | Grade 3 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Tenderness | Grade 4 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Erythema/Redness | Grade 0 | 730 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Erythema/Redness | Grade 1 | 4 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Erythema/Redness | Grade 2 | 1 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Erythema/Redness | Grade 3 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Erythema/Redness | Grade 4 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Induration/Swelling | Grade 0 | 727 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Induration/Swelling | Grade 1 | 7 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Induration/Swelling | Grade 2 | 1 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Induration/Swelling | Grade 3 | 0 Participants |
| Lot 1 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Induration/Swelling | Grade 4 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Induration/Swelling | Grade 2 | 1 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Temperature | Grade 0 | 301 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Decreased Appetite | Grade 0 | 353 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Temperature | Grade 1 | 51 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Erythema/Redness | Grade 0 | 357 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Temperature | Grade 2 | 7 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Decreased Appetite | Grade 1 | 6 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Temperature | Grade 3 | 1 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Induration/Swelling | Grade 0 | 353 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Temperature | Grade 4 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Decreased Appetite | Grade 2 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Cutaneous Rash | Grade 0 | 358 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Erythema/Redness | Grade 1 | 3 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Cutaneous Rash | Grade 1 | 2 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Decreased Appetite | Grade 3 | 1 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Cutaneous Rash | Grade 2 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Induration/Swelling | Grade 4 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Cutaneous Rash | Grade 3 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Decreased Appetite | Grade 4 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Cutaneous Rash | Grade 4 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Erythema/Redness | Grade 2 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Irritability | Grade 0 | 316 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Tenderness | Grade 0 | 296 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Irritability | Grade 1 | 41 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Induration/Swelling | Grade 1 | 6 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Irritability | Grade 2 | 3 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Tenderness | Grade 1 | 55 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Irritability | Grade 3 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Erythema/Redness | Grade 3 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Irritability | Grade 4 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Tenderness | Grade 2 | 9 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Drowsiness | Grade 0 | 352 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Induration/Swelling | Grade 3 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Drowsiness | Grade 1 | 8 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Tenderness | Grade 3 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Drowsiness | Grade 2 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Erythema/Redness | Grade 4 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Drowsiness | Grade 3 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Tenderness | Grade 4 | 0 Participants |
| Lot 2 | Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3 | Drowsiness | Grade 4 | 0 Participants |
Primary
Number and Percentage of Subjects With EPI Vaccine Immune Responses (Diphtheria, Tetanus, Hepatitis B, Hib, Polio and Rotavirus)
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.
Time frame: 4 weeks after the third dose
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 2 | Number and Percentage of Subjects With EPI Vaccine Immune Responses (Diphtheria, Tetanus, Hepatitis B, Hib, Polio and Rotavirus) | Anti-Rotavirus concentration ≥ 20 U/mL | 61 Participants |
| Lot 2 | 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 | 225 Participants |
| Lot 2 | 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) | 225 Participants |
| Lot 2 | 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 | 225 Participants |
| Lot 2 | 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) | 222 Participants |
| Lot 2 | Number and Percentage of Subjects With EPI Vaccine Immune Responses (Diphtheria, Tetanus, Hepatitis B, Hib, Polio and Rotavirus) | Anti-HBsAg concentration ≥ 10 mIU/mL | 224 Participants |
| Lot 2 | 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) | 182 Participants |
| Lot 2 | 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 | 224 Participants |
95% CI: [-0.4, 2.5]
95% CI: [-2.5, 1.2]
95% CI: [-1.3, 1.5]
95% CI: [-3.2, 9.3]
95% CI: [-3, 1.8]
95% CI: [-7.1, 7.1]
Primary
Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL
Number and Percentage of subjects with serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL
Time frame: 4 weeks after the third dose
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lot 1 | Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL | Pn IgG Type 1 | 1454 Participants |
| Lot 1 | Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL | Pn IgG Type 5 | 1435 Participants |
| Lot 1 | Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL | Pn IgG Type 6A | 1193 Participants |
| Lot 1 | Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL | Pn IgG Type 6B | 1142 Participants |
| Lot 1 | Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL | Pn IgG Type 7F | 1443 Participants |
| Lot 1 | Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL | Pn IgG Type 9V | 1391 Participants |
| Lot 1 | Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL | Pn IgG Type 14 | 1437 Participants |
| Lot 1 | Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL | Pn IgG Type 19A | 1386 Participants |
| Lot 1 | Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL | Pn IgG Type 19F | 1427 Participants |
| Lot 1 | Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL | Pn IgG Type 23F | 1372 Participants |
| Lot 2 | Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL | Pn IgG Type 19A | 555 Participants |
| Lot 2 | Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL | Pn IgG Type 1 | 717 Participants |
| Lot 2 | Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL | Pn IgG Type 9V | 690 Participants |
| Lot 2 | Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL | Pn IgG Type 5 | 692 Participants |
| Lot 2 | Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL | Pn IgG Type 23F | 557 Participants |
| Lot 2 | Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL | Pn IgG Type 6A | 555 Participants |
| Lot 2 | Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL | Pn IgG Type 14 | 715 Participants |
| Lot 2 | Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL | Pn IgG Type 6B | 555 Participants |
| Lot 2 | Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL | Pn IgG Type 19F | 713 Participants |
| Lot 2 | Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL | Pn IgG Type 7F | 709 Participants |
97.5% CI: [0, 1.9]
97.5% CI: [1.2, 5]
Comparison: Synflorix proportion of responders for serotype 6A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL97.5% CI: [1.1, 9.5]
97.5% CI: [-2.2, 6.4]
97.5% CI: [-0.1, 2.7]
97.5% CI: [-1.9, 2.5]
97.5% CI: [-1.4, 1]
Comparison: Synflorix proportion of responders for serotype 19A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL97.5% CI: [15.1, 22.5]
97.5% CI: [-1.9, 0.5]
97.5% CI: [13.6, 21.1]
Primary
Serotype-specific Geometric Mean Concentration of IgG Antibody
Serotype-specific concentrations of immunoglobulin G (IgG) antibody measured by ELISA
Time frame: 4 weeks after the third dose
Population: All subjects who received all primary series doses of study vaccines, had post-dose immunogenicity measurement(s) with no major protocol deviations
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Lot 1 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 1 | 4.08 µg/mL |
| Lot 1 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 5 | 1.34 µg/mL |
| Lot 1 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 6A | 1.05 µg/mL |
| Lot 1 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 6B | 1.30 µg/mL |
| Lot 1 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 7F | 2.79 µg/mL |
| Lot 1 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 9V | 1.28 µg/mL |
| Lot 1 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 14 | 4.99 µg/mL |
| Lot 1 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 19A | 1.53 µg/mL |
| Lot 1 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 19F | 4.20 µg/mL |
| Lot 1 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 23F | 1.61 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 19F | 5.02 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 1 | 4.24 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 9V | 1.19 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 7F | 2.55 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 5 | 1.80 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 23F | 1.57 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 19A | 1.66 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 6A | 0.95 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 14 | 5.37 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 6B | 0.92 µg/mL |
| Lot 3 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 19A | 1.74 µg/mL |
| Lot 3 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 6B | 1.49 µg/mL |
| Lot 3 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 7F | 3.70 µg/mL |
| Lot 3 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 9V | 1.46 µg/mL |
| Lot 3 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 19F | 3.89 µg/mL |
| Lot 3 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 14 | 5.25 µg/mL |
| Lot 3 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 1 | 4.58 µg/mL |
| Lot 3 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 23F | 1.56 µg/mL |
| Lot 3 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 5 | 1.84 µg/mL |
| Lot 3 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 6A | 1.01 µg/mL |
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)95% CI: [0.88, 1.05]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)95% CI: [0.69, 0.81]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)95% CI: [0.96, 1.26]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)95% CI: [1.18, 1.69]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)95% CI: [0.99, 1.2]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)95% CI: [0.98, 1.18]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)95% CI: [0.81, 1.07]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)95% CI: [0.83, 1.04]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)95% CI: [0.76, 0.92]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)95% CI: [0.91, 1.15]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)95% CI: [0.82, 0.97]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 295% CI: [0.67, 0.8]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 295% CI: [0.91, 1.2]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)95% CI: [0.74, 1.04]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)95% CI: [0.68, 0.83]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)95% CI: [0.8, 0.97]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)95% CI: [0.83, 1.09]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)95% CI: [0.79, 0.98]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)95% CI: [0.97, 1.2]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)95% CI: [0.92, 1.15]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)95% CI: [0.85, 1.01]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)95% CI: [0.9, 1.07]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)95% CI: [0.82, 1.09]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)95% CI: [0.52, 0.74]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)95% CI: [0.62, 0.76]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)95% CI: [0.74, 0.9]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)95% CI: [0.89, 1.17]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)95% CI: [0.85, 1.06]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)95% CI: [1.16, 1.44]
Comparison: The 3 lots were to be considered equivalent if, for each serotype, all 3 CIs for IgG GMC ratios 4 weeks after the primary vaccination series lay within the interval (0.5, 2)95% CI: [0.89, 1.13]
Primary
Serotype-specific Geometric Mean Concentration of IgG Antibody
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.
Time frame: 4 weeks after the third dose
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Lot 1 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 1 | 4.29 µg/mL |
| Lot 1 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 5 | 1.65 µg/mL |
| Lot 1 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 6A | 1.00 µg/mL |
| Lot 1 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 6B | 1.21 µg/mL |
| Lot 1 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 7F | 2.97 µg/mL |
| Lot 1 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 9V | 1.31 µg/mL |
| Lot 1 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 14 | 5.20 µg/mL |
| Lot 1 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 19A | 1.64 µg/mL |
| Lot 1 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 19F | 4.35 µg/mL |
| Lot 1 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 23F | 1.58 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 19A | 1.13 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 1 | 1.99 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 9V | 1.42 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 5 | 1.20 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 23F | 0.87 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 6A | 1.13 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 14 | 4.24 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 6B | 1.13 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 19F | 5.93 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 7F | 2.29 µg/mL |
97.5% CI: [2, 2.32]
97.5% CI: [1.28, 1.47]
Comparison: Synflorix proportion of responders for serotype 6A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL97.5% CI: [0.78, 1.01]
97.5% CI: [0.93, 1.24]
97.5% CI: [1.19, 1.41]
97.5% CI: [0.85, 1]
97.5% CI: [1.1, 1.37]
Comparison: Synflorix proportion of responders for serotype 19A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL97.5% CI: [1.3, 1.63]
97.5% CI: [0.67, 0.8]
97.5% CI: [1.63, 2.01]
Secondary
6A and 19A Serotype Specific Geometric Mean Concentration of IgG Antibody
6A and 19A Serotype Specific Immune Responses in terms of IgG GMCs measured by ELISA
Time frame: 4 weeks after the third dose
Population: 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
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Lot 1 | 6A and 19A Serotype Specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 6A | 1.00 µg/mL |
| Lot 1 | 6A and 19A Serotype Specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 19A | 1.64 µg/mL |
| Lot 2 | 6A and 19A Serotype Specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 6A | 0.12 µg/mL |
| Lot 2 | 6A and 19A Serotype Specific Geometric Mean Concentration of IgG Antibody | Pn IgG Type 19A | 0.29 µg/mL |
97.5% CI: [7.68, 9.43]
97.5% CI: [5.14, 6.18]
Secondary
Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose
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
Time frame: 4 weeks post booster vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 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 | 3063 titer |
| Lot 2 | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 19F | 1592 titer |
| Lot 2 | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 6B | 2897 titer |
| Lot 2 | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 7F | 6977 titer |
| Lot 2 | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 9V | 1155 titer |
| Lot 2 | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 14 | 3069 titer |
| Lot 2 | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 23F | 3847 titer |
| Lot 2 | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 19A | 645.6 titer |
| Lot 2 | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 1 | 344.5 titer |
| Lot 2 | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 5 | 409.9 titer |
| Lot 3 | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 19A | 8.89 titer |
| Lot 3 | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 14 | 866.8 titer |
| Lot 3 | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 23F | 211.7 titer |
| Lot 3 | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 1 | 29.76 titer |
| Lot 3 | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 6B | 495.2 titer |
| Lot 3 | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 9V | 417.0 titer |
| Lot 3 | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 19F | 801.0 titer |
| Lot 3 | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 5 | 112.9 titer |
| Lot 3 | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 7F | 1438 titer |
| Lot 3 | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 6A | 6.44 titer |
| 4 Weeks Post Booster-Synflorix | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 7F | 4036 titer |
| 4 Weeks Post Booster-Synflorix | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 19A | 53.15 titer |
| 4 Weeks Post Booster-Synflorix | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 9V | 1229 titer |
| 4 Weeks Post Booster-Synflorix | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 23F | 1213 titer |
| 4 Weeks Post Booster-Synflorix | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 14 | 1401 titer |
| 4 Weeks Post Booster-Synflorix | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 5 | 360.6 titer |
| 4 Weeks Post Booster-Synflorix | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 6A | 39.96 titer |
| 4 Weeks Post Booster-Synflorix | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 6B | 1610 titer |
| 4 Weeks Post Booster-Synflorix | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 1 | 187.2 titer |
| 4 Weeks Post Booster-Synflorix | Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose | OPA Type 19F | 1580 titer |
95% CI: [2.15, 4.04]
95% CI: [1.06, 2.46]
95% CI: [3.88, 9.21]
95% CI: [2.72, 4.44]
95% CI: [2.06, 3.13]
95% CI: [1.83, 3.42]
95% CI: [2.48, 5.69]
95% CI: [2.92, 5.18]
95% CI: [4.45, 10.52]
95% CI: [1.64, 3.65]
95% CI: [2.47, 5.36]
95% CI: [1.8, 3.14]
95% CI: [3.49, 7.06]
95% CI: [4.97, 7.96]
95% CI: [2.56, 3.98]
95% CI: [3.55, 10.84]
95% CI: [2.25, 4.7]
95% CI: [2.13, 3.69]
95% CI: [1.45, 2.68]
95% CI: [3.8, 8.63]
Secondary
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
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
Time frame: 4 weeks post booster vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 2 | 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 | 4.86 µg/mL |
| Lot 2 | 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 | 6.18 µg/mL |
| Lot 2 | 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 | 8.32 µg/mL |
| Lot 2 | 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 | 6.36 µg/mL |
| Lot 2 | 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 | 1.80 µg/mL |
| Lot 2 | 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 | 6.84 µg/mL |
| Lot 2 | 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 | 4.11 µg/mL |
| Lot 2 | 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 | 3.97 µg/mL |
| Lot 2 | 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 | 5.71 µg/mL |
| Lot 2 | 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 | 1.31 µg/mL |
| Lot 3 | 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 | 0.26 µg/mL |
| Lot 3 | 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 | 3.86 µg/mL |
| Lot 3 | 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 | 0.94 µg/mL |
| Lot 3 | 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 | 2.12 µg/mL |
| Lot 3 | 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 | 1.15 µg/mL |
| Lot 3 | 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 | 1.43 µg/mL |
| Lot 3 | 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 | 6.31 µg/mL |
| Lot 3 | 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 | 1.26 µg/mL |
| Lot 3 | 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 | 2.49 µg/mL |
| Lot 3 | 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 | 0.12 µg/mL |
| 4 Weeks Post Booster-Synflorix | 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 | 4.07 µg/mL |
| 4 Weeks Post Booster-Synflorix | 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 | 0.95 µg/mL |
| 4 Weeks Post Booster-Synflorix | 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 | 2.08 µg/mL |
| 4 Weeks Post Booster-Synflorix | 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 | 2.15 µg/mL |
| 4 Weeks Post Booster-Synflorix | 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 | 4.67 µg/mL |
| 4 Weeks Post Booster-Synflorix | 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 | 0.84 µg/mL |
| 4 Weeks Post Booster-Synflorix | 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 | 0.42 µg/mL |
| 4 Weeks Post Booster-Synflorix | 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 | 4.44 µg/mL |
| 4 Weeks Post Booster-Synflorix | 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 | 2.47 µg/mL |
| 4 Weeks Post Booster-Synflorix | 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 | 9.79 µg/mL |
95% CI: [1.31, 1.52]
95% CI: [0.81, 0.95]
95% CI: [4.01, 4.96]
95% CI: [5.7, 7.26]
95% CI: [1.89, 2.19]
95% CI: [1.29, 1.5]
95% CI: [1.21, 1.51]
95% CI: [2.4, 2.91]
95% CI: [1.36, 1.63]
95% CI: [2.29, 2.72]
95% CI: [1.06, 1.28]
95% CI: [0.61, 0.74]
95% CI: [2.97, 4.11]
95% CI: [3.23, 4.59]
95% CI: [1.47, 1.82]
95% CI: [1.31, 1.62]
95% CI: [1.03, 1.42]
95% CI: [2.99, 4.33]
95% CI: [1.38, 1.75]
95% CI: [1.98, 2.65]
Secondary
Number and Percentage of Subjects With 6A and 19A Serotype-specific Concentrations of Immunoglobulin G Antibody
Subjects with 6A and 19A serotype-specific concentrations of immunoglobulin G (IgG) antibody measured by ELISA
Time frame: 4 weeks after the third dose
Population: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lot 1 | Number and Percentage of Subjects With 6A and 19A Serotype-specific Concentrations of Immunoglobulin G Antibody | Pn IgG Type 6A | 1193 Participants |
| Lot 1 | Number and Percentage of Subjects With 6A and 19A Serotype-specific Concentrations of Immunoglobulin G Antibody | Pn IgG Type 19A | 1386 Participants |
| Lot 2 | Number and Percentage of Subjects With 6A and 19A Serotype-specific Concentrations of Immunoglobulin G Antibody | Pn IgG Type 6A | 62 Participants |
| Lot 2 | Number and Percentage of Subjects With 6A and 19A Serotype-specific Concentrations of Immunoglobulin G Antibody | Pn IgG Type 19A | 293 Participants |
97.5% CI: [69.8, 76.3]
97.5% CI: [50.3, 58.9]
Secondary
Number and Percentage of Subjects With EPI Vaccine Immune Responses (Measles, Rubella and Yellow Fever)
Anti-measles IgG, anti-rubella IgG and anti-yellow fever neutralizing antibody titer
Time frame: 4 weeks post booster vaccination
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lot 1 | Number and Percentage of Subjects With EPI Vaccine Immune Responses (Measles, Rubella and Yellow Fever) | Anti-Measles IgG ≥ 150 mIU/mL | 381 Participants |
| Lot 1 | Number and Percentage of Subjects With EPI Vaccine Immune Responses (Measles, Rubella and Yellow Fever) | Anti- Rubella IgG ≥ 4 IU/mL | 421 Participants |
| Lot 1 | 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 |
| Lot 2 | Number and Percentage of Subjects With EPI Vaccine Immune Responses (Measles, Rubella and Yellow Fever) | Anti-Measles IgG ≥ 150 mIU/mL | 183 Participants |
| Lot 2 | Number and Percentage of Subjects With EPI Vaccine Immune Responses (Measles, Rubella and Yellow Fever) | Anti- Rubella IgG ≥ 4 IU/mL | 204 Participants |
| Lot 2 | Number and Percentage of Subjects With EPI Vaccine Immune Responses (Measles, Rubella and Yellow Fever) | Anti-Yellow Fever neutralizing Ab titer ≥ 1:8 | 201 Participants |
95% CI: [-3.3, 7.4]
95% CI: [-0.9, 4]
95% CI: [0.2, 5.9]
Secondary
Number and Percentage of Subjects With Functional Antibody Responses
Serotype-specific functional antibody titer measured by OPA
Time frame: 4 weeks after the third dose
Population: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lot 1 | Number and Percentage of Subjects With Functional Antibody Responses | OPA Type 6A | 240 Participants |
| Lot 1 | Number and Percentage of Subjects With Functional Antibody Responses | OPA Type 9V | 242 Participants |
| Lot 1 | Number and Percentage of Subjects With Functional Antibody Responses | OPA Type 5 | 244 Participants |
| Lot 1 | Number and Percentage of Subjects With Functional Antibody Responses | OPA Type 14 | 237 Participants |
| Lot 1 | Number and Percentage of Subjects With Functional Antibody Responses | OPA Type 6B | 233 Participants |
| Lot 1 | Number and Percentage of Subjects With Functional Antibody Responses | OPA Type 19A | 228 Participants |
| Lot 1 | Number and Percentage of Subjects With Functional Antibody Responses | OPA Type 1 | 229 Participants |
| Lot 1 | Number and Percentage of Subjects With Functional Antibody Responses | OPA Type 19F | 239 Participants |
| Lot 1 | Number and Percentage of Subjects With Functional Antibody Responses | OPA Type 7F | 247 Participants |
| Lot 1 | Number and Percentage of Subjects With Functional Antibody Responses | OPA Type 23F | 246 Participants |
| Lot 2 | Number and Percentage of Subjects With Functional Antibody Responses | OPA Type 7F | 249 Participants |
| Lot 2 | Number and Percentage of Subjects With Functional Antibody Responses | OPA Type 1 | 188 Participants |
| Lot 2 | Number and Percentage of Subjects With Functional Antibody Responses | OPA Type 5 | 239 Participants |
| Lot 2 | Number and Percentage of Subjects With Functional Antibody Responses | OPA Type 6A | 36 Participants |
| Lot 2 | Number and Percentage of Subjects With Functional Antibody Responses | OPA Type 6B | 212 Participants |
| Lot 2 | Number and Percentage of Subjects With Functional Antibody Responses | OPA Type 23F | 243 Participants |
| Lot 2 | Number and Percentage of Subjects With Functional Antibody Responses | OPA Type 9V | 249 Participants |
| Lot 2 | Number and Percentage of Subjects With Functional Antibody Responses | OPA Type 14 | 242 Participants |
| Lot 2 | Number and Percentage of Subjects With Functional Antibody Responses | OPA Type 19A | 92 Participants |
| Lot 2 | Number and Percentage of Subjects With Functional Antibody Responses | OPA Type 19F | 246 Participants |
95% CI: [0, 6.2]
95% CI: [11, 23.6]
95% CI: [76.7, 86.6]
95% CI: [4.5, 14.6]
95% CI: [-1.1, 2.2]
95% CI: [-4, 2.2]
95% CI: [46, 60.1]
95% CI: [-4.9, 1.2]
Secondary
Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose
Comparison of Serotype-specific booster responses (antibody concentrations) to PNEUMOSIL in comparison to Synflorix 4 weeks after a booster dose
Time frame: 4 weeks post booster vaccination
Population: 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
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose | Pn IgG Type 19A | 0.94 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose | Pn IgG Type 1 | 2.45 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose | Pn IgG Type 9V | 2.07 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose | Pn IgG Type 5 | 0.83 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose | Pn IgG Type 23F | 2.13 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose | Pn IgG Type 6A | 0.42 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose | Pn IgG Type 14 | 4.62 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose | Pn IgG Type 6B | 4.42 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose | Pn IgG Type 19F | 9.70 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose | Pn IgG Type 7F | 4.06 µg/mL |
95% CI: [2.02, 2.71]
95% CI: [1.38, 1.79]
95% CI: [9.67, 14]
95% CI: [1.65, 2.15]
95% CI: [1.37, 1.8]
95% CI: [0.76, 0.99]
95% CI: [1.21, 1.82]
95% CI: [3.52, 5.06]
95% CI: [0.55, 0.73]
95% CI: [1.63, 2.24]
Secondary
Serotype-specific OPA Geometric Mean Titer
Serotype-specific functional antibody titer measured by OPA and expressed as OPA GMT in a subset
Time frame: 4 weeks after the third dose
Population: 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
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Lot 1 | Serotype-specific OPA Geometric Mean Titer | OPA Type 1 | 85.17 titer |
| Lot 1 | Serotype-specific OPA Geometric Mean Titer | OPA Type 5 | 161.34 titer |
| Lot 1 | Serotype-specific OPA Geometric Mean Titer | OPA Type 6A | 1317.16 titer |
| Lot 1 | Serotype-specific OPA Geometric Mean Titer | OPA Type 6B | 913.52 titer |
| Lot 1 | Serotype-specific OPA Geometric Mean Titer | OPA Type 7F | 1833.71 titer |
| Lot 1 | Serotype-specific OPA Geometric Mean Titer | OPA Type 9V | 141.72 titer |
| Lot 1 | Serotype-specific OPA Geometric Mean Titer | OPA Type 14 | 1019.34 titer |
| Lot 1 | Serotype-specific OPA Geometric Mean Titer | OPA 19A | 148.59 titer |
| Lot 1 | Serotype-specific OPA Geometric Mean Titer | OPA 19F | 594.27 titer |
| Lot 1 | Serotype-specific OPA Geometric Mean Titer | OPA 23F | 767.24 titer |
| Lot 2 | Serotype-specific OPA Geometric Mean Titer | OPA 19A | 11.09 titer |
| Lot 2 | Serotype-specific OPA Geometric Mean Titer | OPA Type 1 | 27.55 titer |
| Lot 2 | Serotype-specific OPA Geometric Mean Titer | OPA Type 9V | 376.77 titer |
| Lot 2 | Serotype-specific OPA Geometric Mean Titer | OPA Type 5 | 115.93 titer |
| Lot 2 | Serotype-specific OPA Geometric Mean Titer | OPA 23F | 253.09 titer |
| Lot 2 | Serotype-specific OPA Geometric Mean Titer | OPA Type 6A | 7.06 titer |
| Lot 2 | Serotype-specific OPA Geometric Mean Titer | OPA Type 14 | 1102.64 titer |
| Lot 2 | Serotype-specific OPA Geometric Mean Titer | OPA Type 6B | 467.65 titer |
| Lot 2 | Serotype-specific OPA Geometric Mean Titer | OPA 19F | 895.39 titer |
| Lot 2 | Serotype-specific OPA Geometric Mean Titer | OPA Type 7F | 1586.75 titer |
95% CI: [2.4, 3.98]
95% CI: [1.12, 1.72]
95% CI: [144, 241]
95% CI: [1.42, 2.69]
95% CI: [0.96, 1.39]
95% CI: [0.29, 0.49]
95% CI: [0.67, 1.27]
95% CI: [10.2, 17.7]
95% CI: [0.54, 0.81]
95% CI: [2.25, 4.09]
Secondary
Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose
Comparison of Serotype-specific booster responses (functional response) to PNEUMOSIL in comparison to Synflorix 4 weeks after a booster dose
Time frame: 4 weeks post booster vaccination
Population: 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
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Lot 1 | Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose | OPA Type 1 | 344.53 titer |
| Lot 1 | Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose | OPA Type 5 | 409.87 titer |
| Lot 1 | Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose | OPA Type 6A | 3063.37 titer |
| Lot 1 | Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose | OPA Type 6B | 2824.56 titer |
| Lot 1 | Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose | OPA Type 7F | 6977.27 titer |
| Lot 1 | Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose | OPA Type 9V | 1137.28 titer |
| Lot 1 | Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose | OPA Type 14 | 3114.71 titer |
| Lot 1 | Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose | OPA Type 19A | 645.56 titer |
| Lot 1 | Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose | OPA Type 19F | 1592.40 titer |
| Lot 1 | Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose | OPA Type 23F | 3846.82 titer |
| Lot 2 | Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose | OPA Type 19A | 51.47 titer |
| Lot 2 | Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose | OPA Type 1 | 187.16 titer |
| Lot 2 | Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose | OPA Type 9V | 1229.05 titer |
| Lot 2 | Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose | OPA Type 5 | 360.59 titer |
| Lot 2 | Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose | OPA Type 23F | 1226.89 titer |
| Lot 2 | Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose | OPA Type 6A | 44.98 titer |
| Lot 2 | Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose | OPA Type 14 | 1411.94 titer |
| Lot 2 | Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose | OPA Type 6B | 1610.81 titer |
| Lot 2 | Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose | OPA Type 19F | 1580.46 titer |
| Lot 2 | Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose | OPA Type 7F | 4036.08 titer |
95% CI: [1.25, 2.72]
95% CI: [0.79, 1.64]
95% CI: [37.07, 125.09]
95% CI: [1.25, 2.46]
95% CI: [1.28, 2.34]
95% CI: [0.65, 1.32]
95% CI: [1.38, 3.51]
95% CI: [7.36, 21.37]
95% CI: [0.7, 1.46]
95% CI: [2.21, 4.45]
Other Pre-specified
Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose
Comparison of Serotype-specific booster responses (functional response-OPA) from 4 weeks after a booster dose to one year post booster
Time frame: One year post booster vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Lot 1 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 1 | 345.8 Titer |
| Lot 1 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 5 | 422.9 Titer |
| Lot 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 |
| Lot 1 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 6B | 3012.0 Titer |
| Lot 1 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 7F | 6757.8 Titer |
| Lot 1 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 9V | 1114.9 Titer |
| Lot 1 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 14 | 3128.9 Titer |
| Lot 1 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 19A | 643.6 Titer |
| Lot 1 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 19F | 1651.1 Titer |
| Lot 1 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 23F | 3933.9 Titer |
| Lot 2 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 6A | 118.1 Titer |
| Lot 2 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 19F | 133.5 Titer |
| Lot 2 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 6B | 116.3 Titer |
| Lot 2 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 7F | 1765.9 Titer |
| Lot 2 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 9V | 114.5 Titer |
| Lot 2 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 14 | 215.1 Titer |
| Lot 2 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 23F | 393.8 Titer |
| Lot 2 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 19A | 89.7 Titer |
| Lot 2 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 1 | 11.0 Titer |
| Lot 2 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 5 | 41.4 Titer |
| Lot 3 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 19A | 54.6 Titer |
| Lot 3 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 14 | 1423.1 Titer |
| Lot 3 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 23F | 1219.8 Titer |
| Lot 3 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 1 | 191.7 Titer |
| Lot 3 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 6B | 1613.8 Titer |
| Lot 3 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 9V | 1231.4 Titer |
| Lot 3 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 19F | 1611.8 Titer |
| Lot 3 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 5 | 369.6 Titer |
| Lot 3 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 7F | 4033.5 Titer |
| Lot 3 | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 6A | 49.9 Titer |
| 4 Weeks Post Booster-Synflorix | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 7F | 1851.8 Titer |
| 4 Weeks Post Booster-Synflorix | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 19A | 17.6 Titer |
| 4 Weeks Post Booster-Synflorix | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 9V | 158.2 Titer |
| 4 Weeks Post Booster-Synflorix | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 23F | 91.6 Titer |
| 4 Weeks Post Booster-Synflorix | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 14 | 193.4 Titer |
| 4 Weeks Post Booster-Synflorix | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 5 | 31.6 Titer |
| 4 Weeks Post Booster-Synflorix | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 6A | 8.3 Titer |
| 4 Weeks Post Booster-Synflorix | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 6B | 31.1 Titer |
| 4 Weeks Post Booster-Synflorix | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 1 | 8.7 Titer |
| 4 Weeks Post Booster-Synflorix | Comparison of Functional Response (OPA) From 4 Weeks After a Booster Dose to One Year Post Booster Dose | OPA Type 19F | 139.8 Titer |
95% CI: [0.03, 0.06]
95% CI: [0.09, 0.14]
95% CI: [0.03, 0.08]
95% CI: [0.03, 0.07]
95% CI: [0.18, 0.38]
95% CI: [0.06, 0.23]
95% CI: [0.05, 0.11]
95% CI: [0.09, 0.3]
95% CI: [0.05, 0.18]
95% CI: [0.08, 0.18]
95% CI: [0.03, 0.06]
95% CI: [0.05, 0.1]
95% CI: [0.09, 0.48]
95% CI: [0.01, 0.03]
95% CI: [0.3, 0.65]
95% CI: [0.06, 0.2]
95% CI: [0.06, 0.22]
95% CI: [0.14, 0.49]
95% CI: [0.06, 0.14]
95% CI: [0.05, 0.12]
Other Pre-specified
Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a Booster Dose to One Year After a Booster Dose
Comparison of Serotype-specific responses (antibody concentrations) measured by ELISA from 4 weeks after a booster dose to one year after a booster dose
Time frame: One year post booster vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 2 | 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 | 0.73 µg/mL |
| Lot 2 | 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 | 0.82 µg/mL |
| Lot 2 | 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 | 0.90 µg/mL |
| Lot 2 | 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 | 0.64 µg/mL |
| Lot 2 | 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 | 0.38 µg/mL |
| Lot 2 | 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 | 0.99 µg/mL |
| Lot 2 | 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 | 0.43 µg/mL |
| Lot 2 | 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 | 0.91 µg/mL |
| Lot 2 | 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 | 0.30 µg/mL |
| Lot 2 | 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 | 0.40 µg/mL |
| Lot 3 | 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 | 1.00 µg/mL |
| Lot 3 | 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 | 4.61 µg/mL |
| Lot 3 | 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 | 2.12 µg/mL |
| Lot 3 | 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 | 2.52 µg/mL |
| Lot 3 | 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 | 4.45 µg/mL |
| Lot 3 | 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 | 2.08 µg/mL |
| Lot 3 | 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 | 9.80 µg/mL |
| Lot 3 | 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 | 0.85 µg/mL |
| Lot 3 | 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 | 4.14 µg/mL |
| Lot 3 | 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 | 0.43 µg/mL |
| 4 Weeks Post Booster-Synflorix | 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 | 0.49 µg/mL |
| 4 Weeks Post Booster-Synflorix | 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 | 0.66 µg/mL |
| 4 Weeks Post Booster-Synflorix | 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 | 0.41 µg/mL |
| 4 Weeks Post Booster-Synflorix | 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 | 0.29 µg/mL |
| 4 Weeks Post Booster-Synflorix | 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 | 0.71 µg/mL |
| 4 Weeks Post Booster-Synflorix | 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 | 0.34 µg/mL |
| 4 Weeks Post Booster-Synflorix | 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 | 0.31 µg/mL |
| 4 Weeks Post Booster-Synflorix | 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 | 0.62 µg/mL |
| 4 Weeks Post Booster-Synflorix | 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 | 0.18 µg/mL |
| 4 Weeks Post Booster-Synflorix | 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 | 1.35 µg/mL |
95% CI: [0.05, 0.06]
95% CI: [0.27, 0.33]
95% CI: [0.13, 0.16]
95% CI: [0.1, 0.11]
95% CI: [0.09, 0.11]
95% CI: [0.19, 0.23]
95% CI: [0.13, 0.17]
95% CI: [0.2, 0.26]
95% CI: [0.12, 0.15]
95% CI: [0.1, 0.12]
95% CI: [0.06, 0.08]
95% CI: [0.35, 0.45]
95% CI: [0.62, 0.86]
95% CI: [0.12, 0.16]
95% CI: [0.11, 0.13]
95% CI: [0.18, 0.22]
95% CI: [0.13, 0.19]
95% CI: [0.52, 0.78]
95% CI: [0.12, 0.16]
95% CI: [0.12, 0.16]
Other Pre-specified
Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster
Treatment group proportions and treatment-group difference in proportions of IgG responders (IgG concentration ≥ 0.35 μg/mL)
Time frame: One Year Post Booster Vaccination
Population: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lot 1 | Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster | Pn IgG Type 1 | 150 Participants |
| Lot 1 | Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster | Pn IgG Type 5 | 223 Participants |
| Lot 1 | Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster | Pn IgG Type 6A | 306 Participants |
| Lot 1 | Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster | Pn IgG Type 6B | 344 Participants |
| Lot 1 | Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster | Pn IgG Type 7F | 296 Participants |
| Lot 1 | Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster | Pn IgG Type 9V | 209 Participants |
| Lot 1 | Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster | Pn IgG Type 14 | 322 Participants |
| Lot 1 | Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster | Pn IgG Type 19A | 316 Participants |
| Lot 1 | Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster | Pn IgG Type 19F | 301 Participants |
| Lot 1 | Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster | Pn IgG Type 23F | 224 Participants |
| Lot 2 | Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster | Pn IgG Type 19A | 128 Participants |
| Lot 2 | Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster | Pn IgG Type 1 | 44 Participants |
| Lot 2 | Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster | Pn IgG Type 9V | 106 Participants |
| Lot 2 | Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster | Pn IgG Type 5 | 99 Participants |
| Lot 2 | Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster | Pn IgG Type 23F | 79 Participants |
| Lot 2 | Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster | Pn IgG Type 6A | 97 Participants |
| Lot 2 | Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster | Pn IgG Type 14 | 134 Participants |
| Lot 2 | Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster | Pn IgG Type 6B | 143 Participants |
| Lot 2 | Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster | Pn IgG Type 19F | 174 Participants |
| Lot 2 | Proportions and Treatment Group Difference in Proportions of IgG Responders 1 Year Post Booster | Pn IgG Type 7F | 117 Participants |
95% CI: [8, 23.7]
95% CI: [-1.4, 15.8]
95% CI: [21.8, 38.1]
95% CI: [10.1, 23.6]
95% CI: [8.4, 24.5]
95% CI: [-8.8, 8.5]
95% CI: [7.5, 22.3]
95% CI: [7.3, 22.5]
95% CI: [-19, -8]
95% CI: [8.2, 25.4]
Other Pre-specified
Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios One Year Post Booster
Comparison of Serotype-specific immune persistence responses (antibody concentrations) to PNEUMOSIL in comparison to Synflorix one year post booster
Time frame: One year post booster vaccination
Population: 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
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 1 | 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 |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios One Year Post Booster | Pn IgG Type 19A | 0.66 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios One Year Post Booster | Pn IgG Type 1 | 0.18 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios One Year Post Booster | Pn IgG Type 9V | 0.41 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios One Year Post Booster | Pn IgG Type 5 | 0.34 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios One Year Post Booster | Pn IgG Type 23F | 0.29 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios One Year Post Booster | Pn IgG Type 6A | 0.31 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios One Year Post Booster | Pn IgG Type 14 | 0.71 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios One Year Post Booster | Pn IgG Type 6B | 0.62 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios One Year Post Booster | Pn IgG Type 19F | 1.35 µg/mL |
| Lot 2 | Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios One Year Post Booster | Pn IgG Type 7F | 0.49 µg/mL |
95% CI: [1.42, 1.89]
95% CI: [1.03, 1.4]
95% CI: [2.01, 2.78]
95% CI: [1.27, 1.66]
95% CI: [1.12, 1.49]
95% CI: [0.81, 1.09]
95% CI: [1.15, 1.72]
95% CI: [1.14, 1.68]
95% CI: [0.5, 0.74]
95% CI: [1.24, 1.81]
Other Pre-specified
Serotype-specific OPA Geometric Mean Titer One Year Post Booster
Serotype-specific functional antibody titer measured by OPA and expressed as OPA GMT in a subset one year post booster
Time frame: One year post booster vaccination
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Lot 1 | Serotype-specific OPA Geometric Mean Titer One Year Post Booster | OPA Type 6A | 118.1 Titer |
| Lot 1 | Serotype-specific OPA Geometric Mean Titer One Year Post Booster | OPA Type 9V | 114.5 Titer |
| Lot 1 | Serotype-specific OPA Geometric Mean Titer One Year Post Booster | OPA Type 5 | 41.4 Titer |
| Lot 1 | Serotype-specific OPA Geometric Mean Titer One Year Post Booster | OPA Type 14 | 215.1 Titer |
| Lot 1 | Serotype-specific OPA Geometric Mean Titer One Year Post Booster | OPA Type 19A | 89.7 Titer |
| Lot 1 | Serotype-specific OPA Geometric Mean Titer One Year Post Booster | OPA Type 6B | 116.3 Titer |
| Lot 1 | Serotype-specific OPA Geometric Mean Titer One Year Post Booster | OPA Type 19F | 133.5 Titer |
| Lot 1 | Serotype-specific OPA Geometric Mean Titer One Year Post Booster | OPA Type 1 | 11.0 Titer |
| Lot 1 | Serotype-specific OPA Geometric Mean Titer One Year Post Booster | OPA Type 23F | 393.8 Titer |
| Lot 1 | Serotype-specific OPA Geometric Mean Titer One Year Post Booster | OPA Type 7F | 1765.9 Titer |
| Lot 2 | Serotype-specific OPA Geometric Mean Titer One Year Post Booster | OPA Type 23F | 91.6 Titer |
| Lot 2 | Serotype-specific OPA Geometric Mean Titer One Year Post Booster | OPA Type 1 | 8.7 Titer |
| Lot 2 | Serotype-specific OPA Geometric Mean Titer One Year Post Booster | OPA Type 5 | 31.6 Titer |
| Lot 2 | Serotype-specific OPA Geometric Mean Titer One Year Post Booster | OPA Type 6A | 8.3 Titer |
| Lot 2 | Serotype-specific OPA Geometric Mean Titer One Year Post Booster | OPA Type 6B | 31.1 Titer |
| Lot 2 | Serotype-specific OPA Geometric Mean Titer One Year Post Booster | OPA Type 7F | 1851.8 Titer |
| Lot 2 | Serotype-specific OPA Geometric Mean Titer One Year Post Booster | OPA Type 9V | 158.2 Titer |
| Lot 2 | Serotype-specific OPA Geometric Mean Titer One Year Post Booster | OPA Type 19A | 17.6 Titer |
| Lot 2 | Serotype-specific OPA Geometric Mean Titer One Year Post Booster | OPA Type 19F | 139.8 Titer |
| Lot 2 | Serotype-specific OPA Geometric Mean Titer One Year Post Booster | OPA Type 14 | 193.4 Titer |
95% CI: [0.8, 2.1]
95% CI: [0.7, 2.4]
95% CI: [6.3, 32.1]
95% CI: [2.1, 6.8]
95% CI: [0.6, 1.6]
95% CI: [0.3, 1.7]
95% CI: [0.5, 2.4]
95% CI: [2.4, 10.8]
95% CI: [0.4, 2.3]
95% CI: [2, 9.4]
Other Pre-specified
Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster
Serotype-specific functional antibody titer measured by OPA
Time frame: One year post booster vaccination
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lot 1 | Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster | OPA Type 1 | 27 Participants |
| Lot 1 | Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster | OPA Type 5 | 39 Participants |
| Lot 1 | Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster | OPA Type 6A | 42 Participants |
| Lot 1 | Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster | OPA Type 6B | 43 Participants |
| Lot 1 | Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster | OPA Type 7F | 50 Participants |
| Lot 1 | Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster | OPA Type 9V | 43 Participants |
| Lot 1 | Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster | OPA Type 14 | 45 Participants |
| Lot 1 | Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster | OPA Type 19A | 43 Participants |
| Lot 1 | Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster | OPA Type 19F | 44 Participants |
| Lot 1 | Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster | OPA Type 23F | 49 Participants |
| Lot 2 | Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster | OPA Type 19A | 24 Participants |
| Lot 2 | Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster | OPA Type 1 | 14 Participants |
| Lot 2 | Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster | OPA Type 9V | 40 Participants |
| Lot 2 | Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster | OPA Type 5 | 37 Participants |
| Lot 2 | Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster | OPA Type 23F | 43 Participants |
| Lot 2 | Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster | OPA Type 6A | 9 Participants |
| Lot 2 | Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster | OPA Type 14 | 41 Participants |
| Lot 2 | Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster | OPA Type 6B | 31 Participants |
| Lot 2 | Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster | OPA Type 19F | 39 Participants |
| Lot 2 | Treatment Group Proportions and Treatment-group Difference in Proportions of Functional Antibody Responders (OPA) One Year Post Booster | OPA Type 7F | 48 Participants |
95% CI: [4.5, 42.1]
95% CI: [-5.8, 25.5]
95% CI: [48.3, 78]
95% CI: [6.4, 39.4]
95% CI: [-5.2, 10.8]
95% CI: [-8.5, 18.3]
95% CI: [16.5, 50.8]
95% CI: [-8.4, 19.2]