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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pneumosil Lot 1 | Experimental | Pneumosil Lot 1 |
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| Pneumosil Lot 2 | Experimental | Pneumosil Lot 2 |
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| Pneumosil Lot 3 | Experimental | Pneumosil Lot 3 |
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| Synflorix | Active Comparator | Synflorix |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumosil | Biological | 10-Valent Pneumococcal Conjugate Vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serotype-specific Geometric Mean Concentration of IgG Antibody | Serotype-specific concentrations of immunoglobulin G (IgG) antibody measured by ELISA | 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 serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL | 4 weeks after the third dose |
| 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. | 4 weeks after the third dose |
| 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. | 4 weeks after the third dose |
| Anti-pertussis Toxoid GMCs for the Pertussis Antigen | Anti-pertussis toxoid GMCs for the pertussis antigen | 4 weeks after the third dose |
| Anti Fimbriae 2/3 IgG GMCs for the Pertussis Antigen | Anti fimbriae 2/3 IgG GMCs for the pertussis antigen |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks after the third dose |
| 6A and 19A Serotype Specific Geometric Mean Concentration of IgG Antibody |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | One Year Post Booster Vaccination |
| Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios One Year Post Booster |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ed Clarke | Medical Research Council (MRC) Unit, The Gambia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Research Council (MRC) Unit, The Gambia | Fajara | The Gambia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33516293 | Derived | Clarke E, Bashorun A, Adigweme I, Badjie Hydara M, Umesi A, Futa A, Ochoge M, Obayemi D, Edem B, Saidy-Jah E, Onwuchekwa C, Dhere R, Sethna V, Kampmann B, Goldblatt D, Taylor D, Andi-Lolo I, Hosken N, Antony K, Innis BL, Alderson MR, Lamola S. Immunogenicity and safety of a novel ten-valent pneumococcal conjugate vaccine in healthy infants in The Gambia: a phase 3, randomised, double-blind, non-inferiority trial. Lancet Infect Dis. 2021 Jun;21(6):834-846. doi: 10.1016/S1473-3099(20)30735-0. Epub 2021 Jan 28. |
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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.
Recruitment period: 21 June 2017 to 29 January 2018
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| ID | Title | Description |
|---|---|---|
| FG000 | Pneumosil Lot 1 | 10-Valent Pneumococcal Conjugate Vaccine Lot 1 |
| FG001 | Pneumosil Lot 2 | 10-Valent Pneumococcal Conjugate Vaccine Lot 2 |
| FG002 | Pneumosil Lot 3 | 10-Valent Pneumococcal Conjugate Vaccine Lot 3 |
| FG003 | Synflorix | Pneumococcal conjugate vaccine (Non-Typeable Haemophilus influenzae (NTHi) protein D, diphtheria or tetanus toxoid conjugates) adsorbed |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary and Booster Phase |
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| Immune Persistence Phase |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pneumosil Lot 1 | Three doses of Pneumosil Lot 1 |
| BG001 | Pneumosil Lot 2 | Three doses of Pneumosil Lot 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at enrollment in days |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serotype-specific Geometric Mean Concentration of IgG Antibody | Serotype-specific concentrations of immunoglobulin G (IgG) antibody measured by ELISA | All subjects who received all primary series doses of study vaccines, had post-dose immunogenicity measurement(s) with no major protocol deviations | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | 4 weeks after the third dose |
|
Recording and reporting of all AEs occurred from signing of the ICF (6-8 weeks of age) through the EOS visit for each subject enrolled in the priming phase of the study (upto 18-20 weeks of age), and through Visit 6 for each study subject enrolled in the booster phase (upto 12 months of age). Subjects included in the third phase for immune persistence evaluation, serious adverse events were monitored from 4 weeks post booster to 12 months after booster.
Immediate solicited local and systemic reactogenicity events and vital signs were assessed 30 minutes following vaccination in all subjects. Half of the subjects in each treatment group were randomly selected to be part of the primary reactogenicity cohort. These subjects and those who received a booster dose were monitored daily at home for 6 days after each study vaccine dose by field workers. As stated in the SAP, pooled PNEUMOSIL data was used for safety analyses.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pneumosil | Three doses of Pneumosil in primary series cohort and three + 1 booster dose in booster cohort |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchiolitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steve Lamola | PATH | + 1 206.302.6067 | slamola@path.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 1, 2018 | Apr 16, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 28, 2018 | Apr 16, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011018 | Pneumonia, Pneumococcal |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| C547294 | PHiD-CV vaccine |
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| Synflorix | Biological | Pneumococcal conjugate vaccine (Non-Typeable Haemophilus influenzae (NTHi) protein D, diphtheria or tetanus toxoid conjugates) adsorbed |
|
| 4 weeks after the third dose |
| 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]. | 7 days (including day of vaccination) |
| 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]. | 7 days (including day of vaccination) |
| 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]. | 7 days (including day of vaccination) |
| 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]. | 7 days (including day of vaccination) |
| 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 | 4 weeks post last vaccination |
| 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 | 4 weeks post last vaccination |
6A and 19A Serotype Specific Immune Responses in terms of IgG GMCs measured by ELISA |
| 4 weeks after the third dose |
| Number and Percentage of Subjects With Functional Antibody Responses | Serotype-specific functional antibody titer measured by OPA | 4 weeks after the third dose |
| Serotype-specific OPA Geometric Mean Titer | Serotype-specific functional antibody titer measured by OPA and expressed as OPA GMT in a subset | 4 weeks after the third 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 | 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 | 4 weeks post booster vaccination |
| 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 | 4 weeks post booster vaccination |
| 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 | 4 weeks post booster vaccination |
| 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 | 4 weeks post booster vaccination |
| 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 | 4 weeks post booster vaccination |
Comparison of Serotype-specific immune persistence responses (antibody concentrations) to PNEUMOSIL in comparison to Synflorix one year post booster |
| One year post booster vaccination |
| 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 | One year post booster vaccination |
| 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 | One year post booster vaccination |
| 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 | One year post booster vaccination |
| 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 | One year post booster vaccination |
| Death |
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| Lost to Follow-up |
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| Physician Decision |
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| Withdrawal by subject's parents |
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| Ineligibility criteria |
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| Not vaccine related |
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| COMPLETED |
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| NOT COMPLETED |
|
|
| BG002 |
| Pneumosil Lot 3 |
Three doses of Pneumosil Lot 3 |
| BG003 | Synflorix | Three doses of Synflorix |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Lot 3 |
Three doses of Pneumosil Lot 3 |
|
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| 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 | 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. | Posted | Count of Participants | Participants | 4 weeks after the third dose |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | 4 weeks after the third dose |
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| 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. | 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. | Posted | Count of Participants | Participants | 4 weeks after the third dose |
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| Primary | Anti-pertussis Toxoid GMCs for the Pertussis Antigen | Anti-pertussis toxoid GMCs for the pertussis antigen | 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 | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | 4 weeks after the third dose |
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| Primary | Anti Fimbriae 2/3 IgG GMCs for the Pertussis Antigen | Anti fimbriae 2/3 IgG GMCs for the pertussis antigen | 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). | Posted | Geometric Mean | 95% Confidence Interval | U/mL | 4 weeks after the third dose |
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| 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]. | 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. | Posted | Count of Participants | Participants | 7 days (including day of vaccination) |
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| 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]. | 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. | Posted | Count of Participants | Participants | 7 days (including day of vaccination) |
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| 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]. | 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. | Posted | Count of Participants | Participants | 7 days (including day of vaccination) |
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| 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]. | 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) | Posted | Count of Participants | Participants | 7 days (including day of vaccination) |
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| 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 | 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. | Posted | Count of Participants | Participants | 4 weeks post last vaccination |
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| 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 | 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. | Posted | Count of Participants | Participants | 4 weeks post last vaccination |
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| 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 | 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 | Posted | Count of Participants | Participants | 4 weeks after the third dose |
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| 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 | 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 | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | 4 weeks after the third dose |
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| Secondary | Number and Percentage of Subjects With Functional Antibody Responses | Serotype-specific functional antibody titer measured by OPA | 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 | Posted | Count of Participants | Participants | 4 weeks after the third dose |
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| Secondary | Serotype-specific OPA Geometric Mean Titer | Serotype-specific functional antibody titer measured by OPA and expressed as OPA GMT in a subset | 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 | Posted | Geometric Mean | 95% Confidence Interval | titer | 4 weeks after the third dose |
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| 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 | 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. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | 4 weeks post booster vaccination |
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| 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 | 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 | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | 4 weeks post booster vaccination |
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| 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 | 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. | Posted | Geometric Mean | 95% Confidence Interval | titer | 4 weeks post booster vaccination |
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| 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 | 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 | Posted | Geometric Mean | 95% Confidence Interval | titer | 4 weeks post booster vaccination |
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| 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 | 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. | Posted | Count of Participants | Participants | 4 weeks post booster vaccination |
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| 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) | 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 | Posted | Count of Participants | Participants | One Year Post Booster Vaccination |
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|
|
| 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 | 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 | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | One year post booster vaccination |
|
|
|
|
| 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 | 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. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | One year post booster vaccination |
|
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | One year post booster vaccination |
|
|
|
|
| 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 | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | One year post booster vaccination |
|
|
|
|
| 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 | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | One year post booster vaccination |
|
|
|
|
| 1 |
| 1,503 |
| 51 |
| 1,503 |
| 1,131 |
| 1,503 |
| EG001 | Synflorix | Three doses of Synflorix in primary series cohort and three + 1 booster dose in booster cohort | 2 | 747 | 26 | 747 | 572 | 747 |
| Gastroenteritis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Dysentery | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Febrile infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| HIV infection WHO clinical stage IV | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Meningitis pneumococcal | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Perinatal HIV infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Periorbital cellulitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Fallot's tetralogy | Congenital, familial and genetic disorders | MedDRA 20.0 | Systematic Assessment |
|
| Trisomy 21 | Congenital, familial and genetic disorders | MedDRA 20.0 | Systematic Assessment |
|
| Atrioventricular septal defect | Congenital, familial and genetic disorders | MedDRA 20.0 | Systematic Assessment |
|
| Intussusception | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Developmental delay | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal wall abscess | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Abscess neck | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Tinea infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Febrile infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Tinea capitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Body tinea | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Skin candida | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
Not provided
Not provided
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018410 | Pneumonia, Bacterial |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Pn IgG Type 5 |
|
|
| Pn IgG Type 6A |
|
|
| Pn IgG Type 6B |
|
|
| Pn IgG Type 7F |
|
|
| Pn IgG Type 9V |
|
|
| Pn IgG Type 14 |
|
|
| Pn IgG Type 19A |
|
|
| Pn IgG Type 19F |
|
|
| Pn IgG Type 23F |
|
|
| Absolute Difference for Type 5 |
| 2.8 |
| 2-Sided |
| 97.5 |
| 1.2 |
| 5.0 |
| Non-Inferiority |
Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL |
| Synflorix proportion of responders for serotype 6A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL | Absolute Difference for Type 6A | 5.2 | 2-Sided | 97.5 | 1.1 | 9.5 | Non-Inferiority | Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL |
| Absolute Difference for Type 6B | 2.0 | 2-Sided | 97.5 | -2.2 | 6.4 | Non-Inferiority | Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL |
| Absolute Difference for Type 7F | 1.0 | 2-Sided | 97.5 | -0.1 | 2.7 | Non-Inferiority | Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL |
| Absolute Difference for Type 9V | 0.1 | 2-Sided | 97.5 | -1.9 | 2.5 | Non-Inferiority | Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL |
| Absolute Difference for Type 14 | -0.3 | 2-Sided | 97.5 | -1.4 | 1.0 | Non-Inferiority | Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL |
| Synflorix proportion of responders for serotype 19A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL | Absolute Difference for Type 19A | 18.7 | 2-Sided | 97.5 | 15.1 | 22.5 | Non-Inferiority | Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL |
| Absolute Difference for Type 19F | -0.8 | 2-Sided | 97.5 | -1.9 | 0.5 | Non-Inferiority | Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL |
| Absolute Difference for Type 23F | 17.2 | 2-Sided | 97.5 | 13.6 | 21.1 | Non-Inferiority | Non-inferiority was to be shown if either the lower limit of the 97.5% CI for the difference in proportions of IgG responders (PNEUMOSIL-Synflorix) exceeded -10% for 7 or more of the 10 serotypes in PNEUMOSIL |
| Pn IgG Type 5 |
|
|
| Pn IgG Type 6A |
|
|
| Pn IgG Type 6B |
|
|
| Pn IgG Type 7F |
|
|
| Pn IgG Type 9V |
|
|
| Pn IgG Type 14 |
|
|
| Pn IgG Type 19A |
|
|
| Pn IgG Type 19F |
|
|
| Pn IgG Type 23F |
|
|
| Pn IgG type 5 GMC Ratio |
| 1.37 |
| 2-Sided |
| 97.5 |
| 1.28 |
| 1.47 |
| Non-Inferiority |
Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL |
| Synflorix proportion of responders for serotype 6A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL | Pn IgG type 6A GMC Ratio | 0.89 | 2-Sided | 97.5 | 0.78 | 1.01 | Non-Inferiority | Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL |
| Pn IgG type 6B GMC Ratio | 1.07 | 2-Sided | 97.5 | 0.93 | 1.24 | Non-Inferiority | Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL |
| Pn IgG type 7F GMC Ratio | 1.30 | 2-Sided | 97.5 | 1.19 | 1.41 | Non-Inferiority | Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL |
| Pn IgG type 9V GMC Ratio | 0.92 | 2-Sided | 97.5 | 0.85 | 1.00 | Non-Inferiority | Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL |
| Pn IgG type 14 GMC Ratio | 1.23 | 2-Sided | 97.5 | 1.10 | 1.37 | Non-Inferiority | Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL |
| Synflorix proportion of responders for serotype 19A was operationally defined as the lowest observed proportion of responders among the 8 serotypes in common with PNEUMOSIL | Pn IgG type 19A GMC Ratio | 1.45 | 2-Sided | 97.5 | 1.30 | 1.63 | Non-Inferiority | Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL |
| Pn IgG type 19F GMC Ratio | 0.73 | 2-Sided | 97.5 | 0.67 | 0.80 | Non-Inferiority | Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL |
| Pn IgG type 23F GMC Ratio | 1.81 | 2-Sided | 97.5 | 1.63 | 2.01 | Non-Inferiority | Non-inferiority was to be shown if the lower limit of the 97.5% CI for the GMC ratio (PNEUMOSIL/Synflorix) exceeded 0.5, for 7 or more of the 10 serotypes in PNEUMOSIL |
| Anti-HBsAg concentration ≥ 10 mIU/mL |
|
| Anti-PRP concentration ≥ 0.15 μg/mL |
|
| Anti-Polio titer ≥ 1:8 (type 1) |
|
| Anti-Polio titer ≥ 1:8 (type 2) |
|
| Anti-Polio titer ≥ 1:8 (type 3) |
|
| Anti-Rotavirus concentration ≥ 20 U/mL |
|
| Absolute difference for Tetanus |
| 0.0 |
| 2-Sided |
CI could not be computed due to 100% response rate |
| Non-Inferiority |
Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix) |
| Absolute difference for Hepatitis B | 0.4 | 2-Sided | 95 | -0.4 | 2.5 | Non-Inferiority | Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix) |
| Absolute difference for Hib | -0.9 | 2-Sided | 95 | -2.5 | 1.2 | Non-Inferiority | Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix) |
| Absolute difference for Polio type 1 | -0.2 | 2-Sided | 95 | -1.3 | 1.5 | Non-Inferiority | Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix) |
| Absolute difference for Polio type 2 | 2.8 | 2-Sided | 95 | -3.2 | 9.3 | Non-Inferiority | Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix) |
| Absolute difference for Polio type 3 | -0.9 | 2-Sided | 95 | -3.0 | 1.8 | Non-Inferiority | Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix) |
| Absolute difference for Rotavirus | 0.2 | 2-Sided | 95 | -7.1 | 7.1 | Non-Inferiority | Non-inferiority was to be shown if the lower limit of the 95% CI exceeded -10% (for comparisons based on the difference in proportions of antibody responders to EPI vaccines between PNEUMOSIL and Synflorix) |
| Grade 2 |
|
| Cutaneous Rash |
|
| Irritability |
|
| Drowsiness |
|
| Decreased Appetite |
|
| Tenderness |
|
| Erythema/Redness |
|
| Induration/Swelling |
|
| Grade 2 |
|
| Grade 3 |
|
| Cutaneous Rash |
|
| Irritability |
|
| Drowsiness |
|
| Decreased Appetite |
|
| Tenderness |
|
| Erythema/Redness |
|
| Induration/Swelling |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Cutaneous Rash |
|
| Irritability |
|
| Drowsiness |
|
| Decreased Appetite |
|
| Tenderness |
|
| Erythema/Redness |
|
| Induration/Swelling |
|
| Grade 2 |
|
| Grade 3 |
|
| Cutaneous Rash |
|
| Irritability |
|
| Drowsiness |
|
| Decreased Appetite |
|
| Tenderness |
|
| Erythema/Redness |
|
| Induration/Swelling |
|
| Moderate-Related |
|
| Moderate-Not related |
|
| Severe-Related |
|
| Severe-Not related |
|
| None |
|
| Furuncle |
|
| Gastroenteritis |
|
| Conjunctivitis |
|
| Bronchiolitis |
|
| Tinea infection |
|
| Febrile infection |
|
| Pneumonia |
|
| Tinea capitis |
|
| Oral candidiasis |
|
| Body tinea |
|
| Impetigo |
|
| Rash pustular |
|
| Skin candida |
|
| Diarrhoea |
|
| Vomiting |
|
| Dermatitis diaper |
|
| Rash maculo-papular |
|
| Rash papular |
|
| Dermatitis contact |
|
| Dermatitis atopic |
|
| Seborrhoeic dermatitis |
|
| Cough |
|
| Pyrexia |
|
| Thermal burn |
|
| None |
|
| Gastroenteritis |
|
| Pneumonia |
|
| Dysentery |
|
| Febrile infection |
|
| HIV infection WHO clinical stage IV |
|
| Meningitis pneumococcal |
|
| Perinatal HIV infection |
|
| Periorbital cellulitis |
|
| Upper respiratory tract infection |
|
| Fallot's tetralogy |
|
| Trisomy 21 |
|
| Atrioventricular septal defect |
|
| Intussusception |
|
| Diarrhoea haemorrhagic |
|
| Vomiting |
|
| Developmental delay |
|
| Malnutrition |
|
| Seizure |
|
| Epistaxis |
|
| Stevens-Johnson syndrome |
|
| Pn IgG Type 19A |
|
|
| Difference for Type 19A |
| 54.7 |
| 2-Sided |
| 97.5 |
| 50.3 |
| 58.9 |
| Superiority |
Proportions with IgG concentration ≥ 0.35 µg/mL will be compared using a z-test for proportions. The test will be done at the two-sided 2.5% significance level to adjust for the two superiority tests. 97.5% CIs for treatment-group differences in response, will also be reported |
| Pn IgG Type 19A |
|
|
| Pn IgG type 19A GMC Ratio |
| 5.64 |
| 2-Sided |
| 97.5 |
| 5.14 |
| 6.18 |
| Superiority |
For each of the two serotypes, GMCs are compared by a two-sample t-test on the difference between means of log10 (antibody). The test was done at the two-sided 2.5% significance level to adjust for the two superiority tests. 97.5% CIs for treatment-group differences in response, are also be reported |
| OPA Type 5 |
|
|
| OPA Type 6A |
|
|
| OPA Type 6B |
|
|
| OPA Type 7F |
|
|
| OPA Type 9V |
|
|
| OPA Type 14 |
|
|
| OPA Type 19A |
|
|
| OPA Type 19F |
|
|
| OPA Type 23F |
|
|
| OPA Type 5 |
| 2.8 |
| 2-Sided |
| 95 |
| -0.0 |
| 6.2 |
| Other |
Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes |
| OPA Type 6A | 82.2 | 2-Sided | 95 | 76.7 | 86.6 | Other | Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes |
| OPA Type 6B | 9.4 | 2-Sided | 95 | 4.5 | 14.6 | Other | Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes |
| OPA Type 7F | 0.4 | 2-Sided | 95 | -1.1 | 2.2 | Other | Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes |
| OPA Type 9V | 0.0 | 2-Sided | CI could not be computed due to 100% response rate | Other | Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes |
| OPA Type14 | -0.8 | 2-Sided | 95 | -4.0 | 2.2 | Other | Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes |
| OPA Type 19A | 53.3 | 2-Sided | 95 | 46.0 | 60.1 | Other | Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes |
| OPA Type 19F | -1.6 | 2-Sided | 95 | -4.9 | 1.2 | Other | Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes |
| OPA Type 23F | 0.0 | 2-Sided | CI could not be computed due to 100% response rate | Other | Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes |
| OPA Type 5 |
|
|
| OPA Type 6A |
|
|
| OPA Type 6B |
|
|
| OPA Type 7F |
|
|
| OPA Type 9V |
|
|
| OPA Type 14 |
|
|
| OPA 19A |
|
|
| OPA 19F |
|
|
| OPA 23F |
|
|
| OPA GMT Ratio-Type 5 |
| 1.39 |
| 2-Sided |
| 95 |
| 1.12 |
| 1.72 |
| Other |
Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) |
| OPA GMT Ratio-Type 6A | 186 | 2-Sided | 95 | 144 | 241 | Other | Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) |
| OPA GMT Ratio-Type 6B | 1.95 | 2-Sided | 95 | 1.42 | 2.69 | Other | Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) |
| OPA GMT Ratio-Type 7F | 1.16 | 2-Sided | 95 | 0.96 | 1.39 | Other | Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) |
| OPA GMT Ratio-Type 9V | 0.38 | 2-Sided | 95 | 0.29 | 0.49 | Other | Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) |
| OPA GMT Ratio-Type 14 | 0.92 | 2-Sided | 95 | 0.67 | 1.27 | Other | Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) |
| OPA GMT Ratio-Type 19A | 13.4 | 2-Sided | 95 | 10.2 | 17.7 | Other | Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) |
| OPA GMT Ratio-Type 19F | 0.66 | 2-Sided | 95 | 0.54 | 0.81 | Other | Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) |
| OPA GMT Ratio-Type 23F | 3.03 | 2-Sided | 95 | 2.25 | 4.09 | Other | Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) |
|
| Pn IgG Type 5 |
|
|
| Pn IgG Type 6A |
|
|
| Pn IgG Type 6B |
|
|
| Pn IgG Type 7F |
|
|
| Pn IgG Type 9V |
|
|
| Pn IgG Type 14 |
|
|
| Pn IgG Type 19A |
|
|
| Pn IgG Type 19F |
|
|
| Pn IgG Type 23F |
|
|
| Pn IgG type 5 GMC Ratio |
| 0.88 |
| 2-Sided |
| 95 |
| 0.81 |
| 0.95 |
| Other |
The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points. |
| Pn IgG type 6A GMC Ratio | 4.46 | 2-Sided | 95 | 4.01 | 4.96 | Other | The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points. |
| Pn IgG type 6B GMC Ratio | 6.43 | 2-Sided | 95 | 5.70 | 7.26 | Other | The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points. |
| Pn IgG type 7F GMC Ratio | 2.04 | 2-Sided | 95 | 1.89 | 2.19 | Other | The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points. |
| Pn IgG type 9V GMC Ratio | 1.39 | 2-Sided | 95 | 1.29 | 1.50 | Other | The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points. |
| Pn IgG type 14 GMC Ratio | 1.35 | 2-Sided | 95 | 1.21 | 1.51 | Other | The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points. |
| Pn IgG type 19A GMC Ratio | 2.64 | 2-Sided | 95 | 2.40 | 2.91 | Other | The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points. |
| Pn IgG type 19F GMC Ratio | 1.49 | 2-Sided | 95 | 1.36 | 1.63 | Other | The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points. |
| Pn IgG type 23F GMC Ratio | 2.50 | 2-Sided | 95 | 2.29 | 2.72 | Other | The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points. |
| Pn IgG type 1 GMC Ratio | 1.17 | 2-Sided | 95 | 1.06 | 1.28 | Other | The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points. |
| Pn IgG type 5 GMC Ratio | 0.67 | 2-Sided | 95 | 0.61 | 0.74 | Other | The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points. |
| Pn IgG type 6A GMC Ratio | 3.49 | 2-Sided | 95 | 2.97 | 4.11 | Other | The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points. |
| Pn IgG type 6B GMC Ratio | 3.85 | 2-Sided | 95 | 3.23 | 4.59 | Other | The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points. |
| Pn IgG type 7F GMC Ratio | 1.63 | 2-Sided | 95 | 1.47 | 1.82 | Other | The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points. |
| Pn IgG type 9V GMC Ratio | 1.46 | 2-Sided | 95 | 1.31 | 1.62 | Other | The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points. |
| Pn IgG type 14 GMC Ratio | 1.21 | 2-Sided | 95 | 1.03 | 1.42 | Other | The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points. |
| Pn IgG type 19A GMC Ratio | 3.60 | 2-Sided | 95 | 2.99 | 4.33 | Other | The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points. |
| Pn IgG type 19F GMC Ratio | 1.55 | 2-Sided | 95 | 1.38 | 1.75 | Other | The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points. |
| Pn IgG type 23F GMC Ratio | 2.29 | 2-Sided | 95 | 1.98 | 2.65 | Other | The comparisons were based on the ratio of IgG GMC post-booster to the IgG GMC post-primary series in the Booster Cohort restricted to subjects who contributed relevant data at both time points. |
| Pn IgG Type 5 |
|
|
| Pn IgG Type 6A |
|
|
| Pn IgG Type 6B |
|
|
| Pn IgG Type 7F |
|
|
| Pn IgG Type 9V |
|
|
| Pn IgG Type 14 |
|
|
| Pn IgG Type 19A |
|
|
| Pn IgG Type 19F |
|
|
| Pn IgG Type 23F |
|
|
| Pn IgG type 5 GMC Ratio |
| 1.57 |
| 2-Sided |
| 95 |
| 1.38 |
| 1.79 |
| Other |
The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models |
| Pn IgG type 6A GMC Ratio | 11.6 | 2-Sided | 95 | 9.67 | 14.0 | Other | The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models |
| Pn IgG type 6B GMC Ratio | 1.89 | 2-Sided | 95 | 1.65 | 2.15 | Other | The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models |
| Pn IgG type 7F GMC Ratio | 1.57 | 2-Sided | 95 | 1.37 | 1.80 | Other | The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models |
| Pn IgG type 9V GMC Ratio | 0.87 | 2-Sided | 95 | 0.76 | 0.99 | Other | The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models |
| Pn IgG type 14 GMC Ratio | 1.48 | 2-Sided | 95 | 1.21 | 1.82 | Other | The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models |
| Pn IgG type 19A GMC Ratio | 4.22 | 2-Sided | 95 | 3.52 | 5.06 | Other | The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models |
| Pn IgG type 19F GMC Ratio | 0.63 | 2-Sided | 95 | 0.55 | 0.73 | Other | The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models |
| Pn IgG type 23F GMC Ratio | 1.91 | 2-Sided | 95 | 1.63 | 2.24 | Other | The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models |
|
| OPA Type 5 |
|
|
| OPA Type 6A |
|
|
| OPA Type 6B |
|
|
| OPA Type 7F |
|
|
| OPA Type 9V |
|
|
| OPA Type 14 |
|
|
| OPA Type 19A |
|
|
| OPA Type 19F |
|
|
| OPA Type 23F |
|
|
| OPA GMT Ratio-Type 5 |
| 2.54 |
| 2-Sided |
| 95 |
| 2.06 |
| 3.13 |
| Other |
The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points |
| OPA GMT Ratio-Type 6A | 2.50 | 2-Sided | 95 | 1.83 | 3.42 | Other | The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points |
| OPA GMT Ratio-Type 6B | 3.76 | 2-Sided | 95 | 2.48 | 5.69 | Other | The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points |
| OPA GMT Ratio-Type 7F | 3.89 | 2-Sided | 95 | 2.92 | 5.18 | Other | The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points |
| OPA GMT Ratio-Type 9V | 6.85 | 2-Sided | 95 | 4.45 | 10.52 | Other | The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points |
| OPA GMT Ratio-Type 14 | 2.45 | 2-Sided | 95 | 1.64 | 3.65 | Other | The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points |
| OPA GMT Ratio-Type 19A | 3.64 | 2-Sided | 95 | 2.47 | 5.36 | Other | The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points |
| OPA GMT Ratio-Type 19F | 2.38 | 2-Sided | 95 | 1.80 | 3.14 | Other | The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points |
| OPA GMT Ratio-Type 23F | 4.97 | 2-Sided | 95 | 3.49 | 7.06 | Other | The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points |
| OPA GMT Ratio-Type 1 | 6.29 | 2-Sided | 95 | 4.97 | 7.96 | Other | The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points |
| OPA GMT Ratio-Type 5 | 3.19 | 2-Sided | 95 | 2.56 | 3.98 | Other | The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points |
| OPA GMT Ratio-Type 6A | 6.21 | 2-Sided | 95 | 3.55 | 10.84 | Other | The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points |
| OPA GMT Ratio-Type 6B | 3.25 | 2-Sided | 95 | 2.25 | 4.70 | Other | The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points |
| OPA GMT Ratio-Type 7F | 2.81 | 2-Sided | 95 | 2.13 | 3.69 | Other | The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points |
| OPA GMT Ratio-Type 9V | 2.95 | 2-Sided | 95 | 2.15 | 4.04 | Other | The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points |
| OPA GMT Ratio-Type 14 | 1.62 | 2-Sided | 95 | 1.06 | 2.46 | Other | The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points |
| OPA GMT Ratio-Type 19A | 5.98 | 2-Sided | 95 | 3.88 | 9.21 | Other | The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points |
| OPA GMT Ratio-Type 19F | 1.97 | 2-Sided | 95 | 1.45 | 2.68 | Other | The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points |
| OPA GMT Ratio-Type 23F | 5.73 | 2-Sided | 95 | 3.80 | 8.63 | Other | The comparisons were based on OPA GMTs 4 weeks post primary series and 4 weeks post booster for the OPA subset of the booster cohort. It was restricted to subjects who contributed relevant data at both time points |
| OPA Type 5 |
|
|
| OPA Type 6A |
|
|
| OPA Type 6B |
|
|
| OPA Type 7F |
|
|
| OPA Type 9V |
|
|
| OPA Type 14 |
|
|
| OPA Type 19A |
|
|
| OPA Type 19F |
|
|
| OPA Type 23F |
|
|
| OPA GMT Ratio-Type 5 |
| 1.14 |
| 2-Sided |
| 95 |
| 0.79 |
| 1.64 |
| Other |
The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models |
| OPA GMT Ratio-Type 6A | 68.10 | 2-Sided | 95 | 37.07 | 125.09 | Other | The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models |
| OPA GMT Ratio-Type 6B | 1.75 | 2-Sided | 95 | 1.25 | 2.46 | Other | The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models |
| OPA GMT Ratio-Type 7F | 1.73 | 2-Sided | 95 | 1.28 | 2.34 | Other | The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models |
| OPA GMT Ratio-Type 9V | 0.93 | 2-Sided | 95 | 0.65 | 1.32 | Other | The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models |
| OPA GMT Ratio-Type 14 | 2.21 | 2-Sided | 95 | 1.38 | 3.51 | Other | The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models |
| OPA GMT Ratio-Type 19A | 12.54 | 2-Sided | 95 | 7.36 | 21.37 | Other | The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models |
| OPA GMT Ratio-Type 19F | 1.01 | 2-Sided | 95 | 0.70 | 1.46 | Other | The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models |
| OPA GMT Ratio-Type 23F | 3.14 | 2-Sided | 95 | 2.21 | 4.45 | Other | The vaccines will be compared using the ratios of the GMT ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs based on log linear random effects models |
| Anti- Rubella IgG ≥ 4 IU/mL |
|
|
| Anti-Yellow Fever neutralizing Ab titer ≥ 1:8 |
|
|
| Absolute difference for rubella |
| 1.0 |
| 2-Sided |
| 95 |
| -0.9 |
| 4.0 |
| Non-Inferiority |
Non-inferiority will be shown if a two-sided 95% CI for the treatment-group difference in response proportions (proportion with Synflorix co-administration minus proportion with PNEUMOSIL co-administration) has an upper limit of < 0.10. |
| Absolute difference for yellow fever | 2.4 | 2-Sided | 95 | 0.2 | 5.9 | Non-Inferiority | Non-inferiority will be shown if a two-sided 95% CI for the treatment-group difference in response proportions (proportion with Synflorix co-administration minus proportion with PNEUMOSIL co-administration) has an upper limit of < 0.10. |
| Pn IgG Type 5 |
|
|
| Pn IgG Type 6A |
|
|
| Pn IgG Type 6B |
|
|
| Pn IgG Type 7F |
|
|
| Pn IgG Type 9V |
|
|
| Pn IgG Type 14 |
|
|
| Pn IgG Type 19A |
|
|
| Pn IgG Type 19F |
|
|
| Pn IgG Type 23F |
|
|
| Absolute Difference for Type 5 |
| 7.2 |
| 2-Sided |
| 95 |
| -1.4 |
| 15.8 |
| Other |
Treatment group difference in proportions |
| Absolute Difference for Type 6A | 30.0 | 2-Sided | 95 | 21.8 | 38.1 | Other | Treatment group difference in proportions |
| Absolute Difference for Type 6B | 16.5 | 2-Sided | 95 | 10.1 | 23.6 | Other | Treatment group difference in proportions |
| Absolute Difference for Type 7F | 16.4 | 2-Sided | 95 | 8.4 | 24.5 | Other | Treatment group difference in proportions |
| Absolute Difference for Type 9V | -0.2 | 2-Sided | 95 | -8.8 | 8.5 | Other | Treatment group difference in proportions |
| Absolute Difference for Type 14 | 14.7 | 2-Sided | 95 | 7.5 | 22.3 | Other | Treatment group difference in proportions |
| Absolute Difference for Type 19A | 14.7 | 2-Sided | 95 | 7.3 | 22.5 | Other | Treatment group difference in proportions |
| Absolute Difference for Type 19F | -13.7 | 2-Sided | 95 | -19.0 | -8.0 | Other | Treatment group difference in proportions |
| Absolute Difference for Type 23F | 16.9 | 2-Sided | 95 | 8.2 | 25.4 | Other | Treatment group difference in proportions |
| Pn IgG Type 5 |
|
|
| Pn IgG Type 6A |
|
|
| Pn IgG Type 6B |
|
|
| Pn IgG Type 7F |
|
|
| Pn IgG Type 9V |
|
|
| Pn IgG Type 14 |
|
|
| Pn IgG Type 19A |
|
|
| Pn IgG Type 19F |
|
|
| Pn IgG Type 23F |
|
|
| Pn IgG type 5 GMC Ratio |
| 1.20 |
| 2-Sided |
| 95 |
| 1.03 |
| 1.40 |
| Other |
The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs |
| Pn IgG type 6A GMC Ratio | 2.36 | 2-Sided | 95 | 2.01 | 2.78 | Other | The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs |
| Pn IgG type 6B GMC Ratio | 1.45 | 2-Sided | 95 | 1.27 | 1.66 | Other | The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs |
| Pn IgG type 7F GMC Ratio | 1.29 | 2-Sided | 95 | 1.12 | 1.49 | Other | The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs |
| Pn IgG type 9V GMC Ratio | 0.94 | 2-Sided | 95 | 0.81 | 1.09 | Other | The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs |
| Pn IgG type 14 GMC Ratio | 1.41 | 2-Sided | 95 | 1.15 | 1.72 | Other | The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs |
| Pn IgG type 19A GMC Ratio | 1.38 | 2-Sided | 95 | 1.14 | 1.68 | Other | The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs |
| Pn IgG type 19F GMC Ratio | 0.61 | 2-Sided | 95 | 0.50 | 0.74 | Other | The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs |
| Pn IgG type 23F GMC Ratio | 1.50 | 2-Sided | 95 | 1.24 | 1.81 | Other | The vaccines were compared using the ratios of the GMC ratios for the two treatment groups, i.e., the PNEUMOSIL ratio divided by the Synflorix ratio, and the corresponding 95% CIs |
|
| Pn IgG Type 5 |
|
|
| Pn IgG Type 6A |
|
|
| Pn IgG Type 6B |
|
|
| Pn IgG Type 7F |
|
|
| Pn IgG Type 9V |
|
|
| Pn IgG Type 14 |
|
|
| Pn IgG Type 19A |
|
|
| Pn IgG Type 19F |
|
|
| Pn IgG Type 23F |
|
|
| Pn IgG type 5 GMC Ratio |
| 0.30 |
| 2-Sided |
| 95 |
| 0.27 |
| 0.33 |
| Other |
The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort. |
| Pn IgG type 6A GMC Ratio | 0.15 | 2-Sided | 95 | 0.13 | 0.16 | Other | The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort. |
| Pn IgG type 6B GMC Ratio | 0.11 | 2-Sided | 95 | 0.10 | 0.11 | Other | The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort. |
| Pn IgG type 7F GMC Ratio | 0.10 | 2-Sided | 95 | 0.09 | 0.11 | Other | The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort. |
| Pn IgG type 9V GMC Ratio | 0.21 | 2-Sided | 95 | 0.19 | 0.23 | Other | The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort. |
| Pn IgG type 14 GMC Ratio | 0.15 | 2-Sided | 95 | 0.13 | 0.17 | Other | The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort. |
| Pn IgG type 19A GMC Ratio | 0.23 | 2-Sided | 95 | 0.20 | 0.26 | Other | The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort. |
| Pn IgG type 19F GMC Ratio | 0.14 | 2-Sided | 95 | 0.12 | 0.15 | Other | The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort. |
| Pn IgG type 23F GMC Ratio | 0.11 | 2-Sided | 95 | 0.10 | 0.12 | Other | The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort. |
| Pn IgG type 1 GMC Ratio | 0.07 | 2-Sided | 95 | 0.06 | 0.08 | Other | The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort. |
| Pn IgG type 5 GMC Ratio | 0.40 | 2-Sided | 95 | 0.35 | 0.45 | Other | The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort. |
| Pn IgG type 6A GMC Ratio | 0.73 | 2-Sided | 95 | 0.62 | 0.86 | Other | The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort. |
| Pn IgG type 6B GMC Ratio | 0.14 | 2-Sided | 95 | 0.12 | 0.16 | Other | The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort. |
| Pn IgG type 7F GMC Ratio | 0.12 | 2-Sided | 95 | 0.11 | 0.13 | Other | The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort. |
| Pn IgG type 9V GMC Ratio | 0.20 | 2-Sided | 95 | 0.18 | 0.22 | Other | The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort. |
| Pn IgG type 14 GMC Ratio | 0.15 | 2-Sided | 95 | 0.13 | 0.19 | Other | The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort. |
| Pn IgG type 19A GMC Ratio | 0.64 | 2-Sided | 95 | 0.52 | 0.78 | Other | The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort. |
| Pn IgG type 19F GMC Ratio | 0.14 | 2-Sided | 95 | 0.12 | 0.16 | Other | The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort. |
| Pn IgG type 23F GMC Ratio | 0.14 | 2-Sided | 95 | 0.12 | 0.16 | Other | The comparisons were based on the ratio of IgG GMC one year post-booster to the IgG GMC 4 weeks post booster in the Booster Cohort. |
| OPA Type 5 |
|
|
| OPA Type 6A |
|
|
| OPA Type 6B |
|
|
| OPA Type 7F |
|
|
| OPA Type 9V |
|
|
| OPA Type 14 |
|
|
| OPA Type 19A |
|
|
| OPA Type 19F |
|
|
| OPA Type 23F |
|
|
| OPA Type 5 |
| 9.9 |
| 2-Sided |
| 95 |
| -5.8 |
| 25.5 |
| Other |
Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster |
| OPA Type 6A | 65.6 | 2-Sided | 95 | 48.3 | 78.0 | Other | Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster |
| OPA Type 6B | 23.2 | 2-Sided | 95 | 6.4 | 39.4 | Other | Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster |
| OPA Type 7F | 2.0 | 2-Sided | 95 | -5.2 | 10.8 | Other | Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster |
| OPA Type 9V | 0.0 | 2-Sided | CI could not be computed due to 100% response rate | Other | Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster |
| OPA Type14 | 4.6 | 2-Sided | 95 | -8.5 | 18.3 | Other | Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster |
| OPA Type 19A | 34.4 | 2-Sided | 95 | 16.5 | 50.8 | Other | Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster |
| OPA Type 19F | 5.0 | 2-Sided | 95 | -8.4 | 19.2 | Other | Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster |
| OPA Type 23F | 0.0 | 2-Sided | CI could not be computed due to 100% response rate | Other | Serotype specific functional antibody responses measured by OPA titer to Pneumosil in comparison with Synflorix for each of the 10 serotypes one year post booster |
| OPA Type 5 |
|
|
| OPA Type 6A |
|
|
| OPA Type 6B |
|
|
| OPA Type 7F |
|
|
| OPA Type 9V |
|
|
| OPA Type 14 |
|
|
| OPA Type 19A |
|
|
| OPA Type 19F |
|
|
| OPA Type 23F |
|
|
| OPA GMT Ratio-Type 5 |
| 1.3 |
| 2-Sided |
| 95 |
| 0.7 |
| 2.4 |
| Other |
Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose |
| OPA GMT Ratio-Type 6A | 14.3 | 2-Sided | 95 | 6.3 | 32.1 | Other | Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose |
| OPA GMT Ratio-Type 6B | 3.7 | 2-Sided | 95 | 2.1 | 6.8 | Other | Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose |
| OPA GMT Ratio-Type 7F | 1.0 | 2-Sided | 95 | 0.6 | 1.6 | Other | Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose |
| OPA GMT Ratio-Type 9V | 0.7 | 2-Sided | 95 | 0.3 | 1.7 | Other | Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose |
| OPA GMT Ratio-Type 14 | 1.1 | 2-Sided | 95 | 0.5 | 2.4 | Other | Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose |
| OPA GMT Ratio-Type 19A | 5.1 | 2-Sided | 95 | 2.4 | 10.8 | Other | Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose |
| OPA GMT Ratio-Type 19F | 1.0 | 2-Sided | 95 | 0.4 | 2.3 | Other | Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose |
| OPA GMT Ratio-Type 23F | 4.3 | 2-Sided | 95 | 2.0 | 9.4 | Other | Serotype specific functional antibody responses measured by OPA to Pneumosil in comparison with Synflorix for each of the 10 serotypes (GMT Ratio) one year post booster dose |
|
| OPA Type 5 |
|
|
| OPA Type 6A |
|
|
| OPA Type 6B |
|
|
| OPA Type 7F |
|
|
| OPA Type 9V |
|
|
| OPA Type 14 |
|
|
| OPA Type 19A |
|
|
| OPA Type 19F |
|
|
| OPA Type 23F |
|
|
| OPA GMT Ratio-Type 5 |
| 0.11 |
| 2-Sided |
| 95 |
| 0.09 |
| 0.14 |
| Other |
The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort. |
| OPA GMT Ratio-Type 6A | 0.05 | 2-Sided | 95 | 0.03 | 0.08 | Other | The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort. |
| OPA GMT Ratio-Type 6B | 0.05 | 2-Sided | 95 | 0.03 | 0.07 | Other | The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort. |
| OPA GMT Ratio-Type 7F | 0.26 | 2-Sided | 95 | 0.18 | 0.38 | Other | The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort. |
| OPA GMT Ratio-Type 9V | 0.12 | 2-Sided | 95 | 0.06 | 0.23 | Other | The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort. |
| OPA GMT Ratio-Type 14 | 0.07 | 2-Sided | 95 | 0.05 | 0.11 | Other | The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort. |
| OPA GMT Ratio-Type 19A | 0.16 | 2-Sided | 95 | 0.09 | 0.30 | Other | The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort. |
| OPA GMT Ratio-Type 19F | 0.09 | 2-Sided | 95 | 0.05 | 0.18 | Other | The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort. |
| OPA GMT Ratio-Type 23F | 0.12 | 2-Sided | 95 | 0.08 | 0.18 | Other | The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort. |
| OPA GMT Ratio-Type 1 | 0.04 | 2-Sided | 95 | 0.03 | 0.06 | Other | The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort. |
| OPA GMT Ratio-Type 5 | 0.07 | 2-Sided | 95 | 0.05 | 0.10 | Other | The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort. |
| OPA GMT Ratio-Type 6A | 0.21 | 2-Sided | 95 | 0.09 | 0.48 | Other | The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort. |
| OPA GMT Ratio-Type 6B | 0.02 | 2-Sided | 95 | 0.01 | 0.03 | Other | The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort. |
| OPA GMT Ratio-Type 7F | 0.44 | 2-Sided | 95 | 0.30 | 0.65 | Other | The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort. |
| OPA GMT Ratio-Type 9V | 0.11 | 2-Sided | 95 | 0.06 | 0.20 | Other | The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort. |
| OPA GMT Ratio-Type 14 | 0.11 | 2-Sided | 95 | 0.06 | 0.22 | Other | The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort. |
| OPA GMT Ratio-Type 19A | 0.26 | 2-Sided | 95 | 0.14 | 0.49 | Other | The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort. |
| OPA GMT Ratio-Type 19F | 0.09 | 2-Sided | 95 | 0.06 | 0.14 | Other | The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort. |
| OPA GMT Ratio-Type 23F | 0.07 | 2-Sided | 95 | 0.05 | 0.12 | Other | The comparisons were based on OPA GMTs 4 weeks post booster and one year post booster for the OPA subset of the booster cohort. |