Pneumonia, Pneumococcal
Conditions
Brief summary
The primary objectives of this study are to evaluate the immunogenicity (antibody response) and safety and tolerability of a 2-dose primary series and booster dose (2+1 schedule) of Pneumosil co-administered with routine pediatric vaccines in healthy infants in The Gambia.
Detailed description
This study will provide data necessary to evaluate the safety and immunogenicity of Pneumosil when administered in an alternative schedule to the 3 dose primary schedule (3+0) evaluated in the Phase 3 pivotal trial (VAC-056; NCT03197376) - namely in a 2 dose primary and booster (2+1) schedule - and compare immunogenicity to that of both currently licensed second-generation pneumococcal conjugate vaccines (Synflorix and Prevenar 13) administered in the same 2+1 schedule. In this prospective, single center, randomized, active-controlled, observer-blind, Phase 3 descriptive study, 660 healthy Gambian pneumococcal conjugate vaccine (PCV)-naïve infants will be randomized 1:1:1 to receive 3 doses of either Pneumosil, Synflorix or Prevenar 13 at 6 weeks, 14 weeks and 9-10 months of age. Standard Expanded Program on Immunization (EPI) vaccinations in The Gambia will be given concomitantly with all 3 doses of study vaccine. The booster vaccination window was extended up to 18 months of age due to a pause in the study due to the coronavirus disease 2019 (COVID-19) pandemic. The study schedule for participants is as follows: * Age 6 weeks: First primary vaccination dose administered * Age 14 weeks: Second primary vaccination dose administered (8 weeks after first primary dose) * Age 18 weeks: Blood sample for immunogenicity testing (4 weeks after second primary dose) * Age 9-18 months: Blood sample for immunogenicity testing and booster vaccination dose administered * Age 10-19 months: Blood sample for immunogenicity testing (4 weeks after booster dose)
Interventions
BIOLOGICALPneumosil
One single dose contains 2 μg of polysaccharide for serotypes 1, 5, 6A, 7F, 9V, 14, 19A, 19F and 23F, and 4 μg for serotype 6B formulated with aluminium phosphate as an adjuvant in an appropriate buffer
BIOLOGICALPrevenar 13
One single dose contains 2.2 µg of the following pneumococcal polysaccharides serotypes - 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F - and 4.4 µg of pneumococcal polysaccharide serotype 6B, all conjugated to CRM197 and absorbed onto aluminum phosphate
BIOLOGICALSynflorix
One single dose contains 1 μg of polysaccharide for serotypes 1, 5, 6B, 7F, 9V, 14, and 23F, and 3μg of serotypes 4, 18C, and 19F formulated with aluminum phosphate as an adjuvant.
Sponsors
Serum Institute of India Pvt. Ltd.
Medical Research Council Unit, The Gambia
University College, London
FHI 360
PATH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
42 Days to 56 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy infants based on medical history and clinical assessment. * 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. * Subjects must have been born full-term, have a weight-to-height Z score of ≥ -2 at the time of enrollment (WHO child growth standard), and be ≥ 3.5 kg at randomization. * Subject's parents must be available for the duration of trial participation
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 study 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 suddenly without apparent cause. * History of meningitis, seizures or any neurological disorder. * Exposure to human immunodeficiency virus (HIV) by history.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | 4 weeks post booster dose | The IgG antibody concentration to each of the 10 serotypes contained in Pneumosil was measured by enzyme-linked immunosorbent assay (ELISA) in serum samples collected 4 weeks after the booster dose (Visit 6). The pneumococcal serotype-specific IgG ELISAs were performed using the World Health Organisation (WHO) reference assay at the WHO Pneumococcal Serology Reference Laboratory, at the Institute of Child Health, University College London, United Kingdom (UK), where the assay was validated. |
| Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Day 0 to Day 6 after each vaccination | Solicited local reactions included tenderness, erythema/redness and induration/swelling at the study vaccine injection site. Solicited systemic reactions included cutaneous rash, fever (based on axillary temperature), irritability, drowsiness, and decreased appetite. The severity of all solicited AEs was graded from mild (Grade 1) to potentially life threatening (Grade 4), based on protocol-defined criteria that were derived from Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (Version 2.0, November 2014). |
| Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post vaccination; approximately 8.5 months overall. | AEs include any intercurrent illness or injury during the study, clinically significant worsening of a preexisting condition, and any solicited AE that occurred or was ongoing 6 days after study vaccine administration. A TEAE is an event that was not present prior to administration of the study vaccine, or increased in intensity after administration of the study vaccine. Unsolicited AEs were graded using the scale below: Grade 1: Mild; asymptomatic or mild symptoms; intervention not indicated. Grade 2: Moderate; minimal, local, or noninvasive intervention indicated. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. Related AEs are AEs where the Investigator determined a reasonable causal relationship between the vaccine administered and the AE based on medical judgement. |
| Number of Participants With Serious Adverse Events (SAEs) | SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall. | An SAE was a specific AE that: * Resulted in death. * Was life-threatening. * Required inpatient hospitalization or prolongation of an existing hospitalization. * Resulted in a persistent or significant disability or incapacity. * Resulted in a congenital anomaly or birth defect |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | 4 weeks after completion of primary vaccinations (at age 18 weeks) | The seroresponse rate was defined as the percentage of infants with serotype-specific IgG antibody concentrations of at least 0.35 μg/mL, which is the reference concentration for assessment of vaccine efficacy against invasive pneumococcal diseases (IPDs). The IgG concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected 4 weeks after the second primary vaccination dose. |
| Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | 4 weeks after completion of primary vaccinations (at age 18 weeks) | The IgG antibody concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected 4 weeks after the second primary vaccination dose. |
| Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | 4 weeks after completion of primary vaccinations (at age 18 weeks) | The OPA seroresponse rate was defined as the percentage of infants with an OPA titer of at least 8. Opsonophagocytic activity was measured using the 4-fold multiplexed opsonophagocytic assay (MOPA). |
| Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | 4 weeks after completion of primary vaccinations (at age 18 weeks) | Opsonophagocytic activity was measured using the 4-fold multiplexed opsonophagocytic assay (MOPA). |
| Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Prior to the booster dose at approximately 9 to 16 months of age | The seroresponse rate was defined as the percentage of infants with serotype-specific IgG concentrations of at least 0.35 μg/mL, which is the reference concentration for assessment of vaccine efficacy against invasive pneumococcal diseases (IPDs). The IgG concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected immediately prior to the booster vaccination dose. |
| Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | 4 weeks post booster dose | The functional activity of the antibody response to the 10 serotypes contained in Pneumosil was determined in serum samples collected 4 weeks after the booster dose in a subset of 50 participants per group. This activity was determined using the 4-fold multiplexed opsonophagocytic assay (MOPA) developed at the University of Alabama at Birmingham, and performed at the WHO Pneumococcal Serology Reference Laboratory, at the Institute of Child Health, University College London, UK, where the assay was validated. A higher titer indicates increased antibody-mediated opsonophagocytosis. |
| Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Prior to the booster dose at approximately 9 to 16 months of age | The OPA seroresponse rate was defined as the percentage of infants with an OPA titer of at least 8. Opsonophagocytic activity was measured using the 4-fold multiplexed opsonophagocytic assay (MOPA) from serum samples collected immediately prior to the booster vaccination dose. |
| Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Prior to the booster dose at approximately 9 to 16 months of age | Opsonophagocytic activity was measured using the 4-fold multiplexed opsonophagocytic assay (MOPA) from serum samples collected immediately prior to the booster vaccination dose. |
| Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | 4 weeks after completion of primary vaccinations (at age 18 weeks) and 4 weeks post booster | Booster response was measured by the ratio of IgG GMCs measured at the post-booster visit to those measured 4 weeks after completion of primary vaccinations. |
| Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | 4 weeks after completion of primary vaccinations (at age 18 weeks) and 4 weeks post booster | OPA booster response was measured by the ratio of OPA GMTs measured at the post-booster visit to those measured 4 weeks after completion of primary vaccinations. |
| Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Prior to the booster dose at approximately 9 to 16 months of age | The IgG antibody concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected immediately prior to the booster vaccination dose. |
| Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | 4 weeks post booster dose | The seroresponse rate was defined as the percentage of infants with serotype-specific IgG antibody concentrations of at least 0.35 μg/mL, which is the reference concentration for assessment of vaccine efficacy against invasive pneumococcal diseases (IPDs). The IgG concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected 4 weeks after the booster dose. |
| Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | 4 weeks post booster dose | Seroresponse rate was also defined as the percentage of infants with serotype-specific IgG antibody concentrations of at least 1.0 μg/mL. The IgG concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected 4 weeks after the booster dose. |
| Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | 4 weeks post booster dose | The OPA seroresponse rate was defined as the percentage of infants with an OPA titer of at least 8. Opsonophagocytic activity was measured using the 4-fold multiplexed opsonophagocytic assay (MOPA) from serum samples taken 4 weeks after the booster vaccination. |
Countries
The Gambia
Participant flow
Recruitment details
Healthy, Gambian male and female, pneumococcal conjugate vaccine (PCV)-naïve infants were screened and enrolled at the Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine (MRCG at LSHTM).
Pre-assignment details
Eligible participants were randomized equally (in a 1:1:1 ratio), based on a pre-established randomization scheme, to receive either Pneumosil, Synflorix or Prevenar 13. Participants were to receive two primary vaccinations plus a booster vaccination at 9-10 months of age. The booster vaccination window was extended up to 18 months of age due to a pause in the study due to the COVID-19 pandemic; actual mean age of booster administration was 12.5 months and ranged from 9 to 16 months.
Participants by arm
| Arm | Count |
|---|---|
| Pneumosil Infants received two primary vaccinations with Pneumosil, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age. | 220 |
| Synflorix Infants received two primary vaccinations with Synflorix, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age. | 220 |
| Prevenar 13 Infants received two primary vaccinations with Prevenar 13, the first at age 6 weeks and the second at age 14 weeks. A booster vaccination was given between 9 and 16 months of age. | 220 |
| Total | 660 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 |
| Overall Study | Death | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 2 | 1 | 1 |
| Overall Study | Met Ineligibility Criteria During the Study | 1 | 1 | 2 |
| Overall Study | Other | 5 | 6 | 7 |
| Overall Study | Parent Requested Withdrawal | 8 | 12 | 9 |
Baseline characteristics
| Characteristic | Total | Pneumosil | Synflorix | Prevenar 13 |
|---|---|---|---|---|
| Age, Continuous | 46.9 days STANDARD_DEVIATION 3.86 | 47.3 days STANDARD_DEVIATION 3.86 | 46.8 days STANDARD_DEVIATION 3.96 | 46.7 days STANDARD_DEVIATION 3.74 |
| Ethnicity Fula | 76 Participants | 26 Participants | 25 Participants | 25 Participants |
| Ethnicity Jola | 74 Participants | 28 Participants | 31 Participants | 15 Participants |
| Ethnicity Mandinka | 351 Participants | 109 Participants | 118 Participants | 124 Participants |
| Ethnicity Manjago | 10 Participants | 5 Participants | 1 Participants | 4 Participants |
| Ethnicity Other | 37 Participants | 13 Participants | 11 Participants | 13 Participants |
| Ethnicity Serahule | 27 Participants | 9 Participants | 9 Participants | 9 Participants |
| Ethnicity Serere | 25 Participants | 9 Participants | 8 Participants | 8 Participants |
| Ethnicity Wolof | 60 Participants | 21 Participants | 17 Participants | 22 Participants |
| Length | 55.40 cm STANDARD_DEVIATION 2.02 | 55.44 cm STANDARD_DEVIATION 1.91 | 55.48 cm STANDARD_DEVIATION 2.02 | 55.29 cm STANDARD_DEVIATION 2.11 |
| Primary Cooking Fuel Source Gas/electricity | 4 Participants | 2 Participants | 1 Participants | 1 Participants |
| Primary Cooking Fuel Source Wood/charcoal | 656 Participants | 218 Participants | 219 Participants | 219 Participants |
| Primary Water Source for Cooking/Drinking Community tap, well or borehole | 134 Participants | 52 Participants | 40 Participants | 42 Participants |
| Primary Water Source for Cooking/Drinking Private tap, well or borehole | 526 Participants | 168 Participants | 180 Participants | 178 Participants |
| Race/Ethnicity, Customized African | 660 Participants | 220 Participants | 220 Participants | 220 Participants |
| Sex: Female, Male Female | 342 Participants | 125 Participants | 108 Participants | 109 Participants |
| Sex: Female, Male Male | 318 Participants | 95 Participants | 112 Participants | 111 Participants |
| Weight | 4.66 kg STANDARD_DEVIATION 0.59 | 4.64 kg STANDARD_DEVIATION 0.55 | 4.68 kg STANDARD_DEVIATION 0.58 | 4.67 kg STANDARD_DEVIATION 0.65 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 220 | 0 / 220 | 1 / 220 |
| other Total, other adverse events | 212 / 220 | 213 / 220 | 211 / 220 |
| serious Total, serious adverse events | 12 / 220 | 10 / 220 | 7 / 220 |
Outcome results
Primary
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster
The IgG antibody concentration to each of the 10 serotypes contained in Pneumosil was measured by enzyme-linked immunosorbent assay (ELISA) in serum samples collected 4 weeks after the booster dose (Visit 6). The pneumococcal serotype-specific IgG ELISAs were performed using the World Health Organisation (WHO) reference assay at the WHO Pneumococcal Serology Reference Laboratory, at the Institute of Child Health, University College London, United Kingdom (UK), where the assay was validated.
Time frame: 4 weeks post booster dose
Population: Primary Per Protocol Immunogenicity Population (PP\_IMM) includes all randomized participants who received all 3 study vaccinations (including booster), contributed post-booster immunogenicity measurements, and with no major protocol deviations that were determined to potentially interfere with immunogenicity assessment. Participants with available data for each serotype are included in the analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Pneumosil | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 1 | 8.45 μg/mL |
| Pneumosil | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 5 | 1.54 μg/mL |
| Pneumosil | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 6A | 9.56 μg/mL |
| Pneumosil | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 6B | 12.46 μg/mL |
| Pneumosil | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 7F | 6.66 μg/mL |
| Pneumosil | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 9V | 3.46 μg/mL |
| Pneumosil | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 14 | 8.28 μg/mL |
| Pneumosil | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 19A | 8.82 μg/mL |
| Pneumosil | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 19F | 11.11 μg/mL |
| Pneumosil | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 23F | 4.95 μg/mL |
| Synflorix | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 19F | 17.31 μg/mL |
| Synflorix | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 1 | 2.90 μg/mL |
| Synflorix | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 9V | 2.45 μg/mL |
| Synflorix | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 7F | 3.15 μg/mL |
| Synflorix | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 5 | 0.80 μg/mL |
| Synflorix | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 23F | 2.16 μg/mL |
| Synflorix | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 19A | 2.39 μg/mL |
| Synflorix | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 6A | 0.60 μg/mL |
| Synflorix | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 14 | 5.02 μg/mL |
| Synflorix | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 6B | 4.96 μg/mL |
| Prevenar 13 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 19A | 12.21 μg/mL |
| Prevenar 13 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 6B | 15.54 μg/mL |
| Prevenar 13 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 7F | 6.31 μg/mL |
| Prevenar 13 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 9V | 3.87 μg/mL |
| Prevenar 13 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 19F | 14.99 μg/mL |
| Prevenar 13 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 14 | 9.17 μg/mL |
| Prevenar 13 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 1 | 5.87 μg/mL |
| Prevenar 13 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 23F | 4.97 μg/mL |
| Prevenar 13 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 5 | 2.04 μg/mL |
| Prevenar 13 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies Four Weeks Post-Booster | Serotype 6A | 10.95 μg/mL |
Comparison: Serotype 1 geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.95% CI: [2.47, 3.44]
Comparison: Serotype 1 geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.95% CI: [1.23, 1.69]
Comparison: Serotype 5 geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.95% CI: [1.66, 2.25]
Comparison: Serotype 5 geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.95% CI: [0.65, 0.88]
Comparison: Serotype 6A geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.95% CI: [12.84, 20.03]
Comparison: Serotype 6A geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.95% CI: [0.72, 1.06]
Comparison: Serotype 6B geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.95% CI: [2.14, 2.95]
Comparison: Serotype 6B geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.95% CI: [0.68, 0.95]
Comparison: Serotype 7F geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.95% CI: [1.83, 2.44]
Comparison: Serotype 7F geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.95% CI: [0.91, 1.22]
Comparison: Serotype 9V geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.95% CI: [1.21, 1.65]
Comparison: Serotype 9V geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.95% CI: [0.76, 1.05]
Comparison: Serotype 14 geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.95% CI: [1.29, 2.1]
Comparison: Serotype 14 geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.95% CI: [0.73, 1.12]
Comparison: Serotype 19A geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.95% CI: [2.91, 4.67]
Comparison: Serotype 19A geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.95% CI: [0.6, 0.87]
Comparison: Serotype 19F geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.95% CI: [0.52, 0.79]
Comparison: Serotype 19F geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.95% CI: [0.62, 0.89]
Comparison: Serotype 23F geometric mean concentration ratio (Pneumosil / Synflorix) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.95% CI: [1.89, 2.76]
Comparison: Serotype 23F geometric mean concentration ratio (Pneumosil / Prevenar 13) and 95% confidence interval (CI). Differences between groups were considered statistically significant if the 95% CI excludes 1.95% CI: [0.82, 1.22]
Primary
Number of Participants With Serious Adverse Events (SAEs)
An SAE was a specific AE that: * Resulted in death. * Was life-threatening. * Required inpatient hospitalization or prolongation of an existing hospitalization. * Resulted in a persistent or significant disability or incapacity. * Resulted in a congenital anomaly or birth defect
Time frame: SAEs were collected from first dose at age 6 weeks up to 4 weeks post booster vaccination, approximately 15.5 months overall.
Population: Safety analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pneumosil | Number of Participants With Serious Adverse Events (SAEs) | Any serious adverse event | 12 Participants |
| Pneumosil | Number of Participants With Serious Adverse Events (SAEs) | Vaccine-related serious adverse events | 0 Participants |
| Synflorix | Number of Participants With Serious Adverse Events (SAEs) | Any serious adverse event | 10 Participants |
| Synflorix | Number of Participants With Serious Adverse Events (SAEs) | Vaccine-related serious adverse events | 0 Participants |
| Prevenar 13 | Number of Participants With Serious Adverse Events (SAEs) | Any serious adverse event | 7 Participants |
| Prevenar 13 | Number of Participants With Serious Adverse Events (SAEs) | Vaccine-related serious adverse events | 0 Participants |
Primary
Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination
Solicited local reactions included tenderness, erythema/redness and induration/swelling at the study vaccine injection site. Solicited systemic reactions included cutaneous rash, fever (based on axillary temperature), irritability, drowsiness, and decreased appetite. The severity of all solicited AEs was graded from mild (Grade 1) to potentially life threatening (Grade 4), based on protocol-defined criteria that were derived from Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (Version 2.0, November 2014).
Time frame: Day 0 to Day 6 after each vaccination
Population: The Safety Analysis Set (Safety Population) included all participants who were randomized, received a study vaccination, and provided post-vaccination safety data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pneumosil | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Any local reaction | 72 Participants |
| Pneumosil | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Any local reaction Grade 3 or higher | 0 Participants |
| Pneumosil | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Tenderness | 70 Participants |
| Pneumosil | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Erythema/Redness | 1 Participants |
| Pneumosil | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Induration/Swelling | 3 Participants |
| Pneumosil | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Any systemic reaction | 160 Participants |
| Pneumosil | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Any systemic reaction Grade 3 or higher | 3 Participants |
| Pneumosil | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Fever Grade 3 or higher | 3 Participants |
| Pneumosil | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Cutaneous Rash | 16 Participants |
| Pneumosil | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Cutaneous Rash Grade 3 or higher | 0 Participants |
| Pneumosil | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Irritability | 105 Participants |
| Pneumosil | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Irritability Grade 3 or higher | 0 Participants |
| Pneumosil | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Drowsiness | 12 Participants |
| Pneumosil | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Drowsiness Grade 3 or higher | 0 Participants |
| Pneumosil | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Decreased Appetite | 25 Participants |
| Pneumosil | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Decreased Appetite Grade 3 or higher | 0 Participants |
| Pneumosil | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Fever | 98 Participants |
| Synflorix | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Fever | 105 Participants |
| Synflorix | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Decreased Appetite | 18 Participants |
| Synflorix | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Fever Grade 3 or higher | 0 Participants |
| Synflorix | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Cutaneous Rash | 7 Participants |
| Synflorix | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Cutaneous Rash Grade 3 or higher | 0 Participants |
| Synflorix | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Decreased Appetite Grade 3 or higher | 0 Participants |
| Synflorix | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Irritability | 110 Participants |
| Synflorix | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Irritability Grade 3 or higher | 0 Participants |
| Synflorix | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Any local reaction | 84 Participants |
| Synflorix | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Drowsiness | 15 Participants |
| Synflorix | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Any local reaction Grade 3 or higher | 0 Participants |
| Synflorix | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Tenderness | 83 Participants |
| Synflorix | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Any systemic reaction | 167 Participants |
| Synflorix | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Erythema/Redness | 3 Participants |
| Synflorix | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Drowsiness Grade 3 or higher | 0 Participants |
| Synflorix | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Induration/Swelling | 5 Participants |
| Synflorix | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Any systemic reaction Grade 3 or higher | 0 Participants |
| Prevenar 13 | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Erythema/Redness | 1 Participants |
| Prevenar 13 | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Fever | 108 Participants |
| Prevenar 13 | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Tenderness | 61 Participants |
| Prevenar 13 | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Any local reaction | 63 Participants |
| Prevenar 13 | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Fever Grade 3 or higher | 2 Participants |
| Prevenar 13 | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Decreased Appetite | 28 Participants |
| Prevenar 13 | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Any systemic reaction | 160 Participants |
| Prevenar 13 | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Cutaneous Rash | 6 Participants |
| Prevenar 13 | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Any systemic reaction Grade 3 or higher | 2 Participants |
| Prevenar 13 | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Induration/Swelling | 1 Participants |
| Prevenar 13 | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Cutaneous Rash Grade 3 or higher | 0 Participants |
| Prevenar 13 | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Any local reaction Grade 3 or higher | 0 Participants |
| Prevenar 13 | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Drowsiness | 18 Participants |
| Prevenar 13 | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Irritability | 101 Participants |
| Prevenar 13 | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Decreased Appetite Grade 3 or higher | 0 Participants |
| Prevenar 13 | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Drowsiness Grade 3 or higher | 0 Participants |
| Prevenar 13 | Number of Participants With Solicited Local and Systemic Adverse Events (AEs) Through Day 6 Following Any Vaccination | Irritability Grade 3 or higher | 0 Participants |
Primary
Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs)
AEs include any intercurrent illness or injury during the study, clinically significant worsening of a preexisting condition, and any solicited AE that occurred or was ongoing 6 days after study vaccine administration. A TEAE is an event that was not present prior to administration of the study vaccine, or increased in intensity after administration of the study vaccine. Unsolicited AEs were graded using the scale below: Grade 1: Mild; asymptomatic or mild symptoms; intervention not indicated. Grade 2: Moderate; minimal, local, or noninvasive intervention indicated. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. Related AEs are AEs where the Investigator determined a reasonable causal relationship between the vaccine administered and the AE based on medical judgement.
Time frame: AEs were collected from first dose at age 6 weeks up to 9 months of age, and then from the date of the booster vaccination through 4 weeks post vaccination; approximately 8.5 months overall.
Population: Safety analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pneumosil | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Any treatment-emergent adverse event (TEAE) | 198 Participants |
| Pneumosil | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Any vaccine-related TEAE | 1 Participants |
| Pneumosil | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Grade 1 TEAE | 196 Participants |
| Pneumosil | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Vaccine-related Grade 1 TEAE | 1 Participants |
| Pneumosil | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Grade 2 TEAE | 22 Participants |
| Pneumosil | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Vaccine-related Grade 2 TEAE | 0 Participants |
| Pneumosil | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Grade 3 TEAE | 11 Participants |
| Pneumosil | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Vaccine-related Grade 3 TEAE | 0 Participants |
| Pneumosil | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Grade 4 TEAE | 0 Participants |
| Pneumosil | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Grade 5 TEAE | 1 Participants |
| Pneumosil | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Vaccine related Grade 5 TEAE | 0 Participants |
| Pneumosil | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | TEAEs leading to study discontinuation | 0 Participants |
| Synflorix | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | TEAEs leading to study discontinuation | 0 Participants |
| Synflorix | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Any treatment-emergent adverse event (TEAE) | 197 Participants |
| Synflorix | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Grade 3 TEAE | 10 Participants |
| Synflorix | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Grade 4 TEAE | 0 Participants |
| Synflorix | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Any vaccine-related TEAE | 2 Participants |
| Synflorix | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Vaccine-related Grade 2 TEAE | 0 Participants |
| Synflorix | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Vaccine related Grade 5 TEAE | 0 Participants |
| Synflorix | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Grade 1 TEAE | 195 Participants |
| Synflorix | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Vaccine-related Grade 3 TEAE | 1 Participants |
| Synflorix | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Grade 2 TEAE | 20 Participants |
| Synflorix | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Vaccine-related Grade 1 TEAE | 1 Participants |
| Synflorix | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Grade 5 TEAE | 0 Participants |
| Prevenar 13 | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Vaccine-related Grade 1 TEAE | 0 Participants |
| Prevenar 13 | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Grade 2 TEAE | 17 Participants |
| Prevenar 13 | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Grade 5 TEAE | 1 Participants |
| Prevenar 13 | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Vaccine-related Grade 2 TEAE | 0 Participants |
| Prevenar 13 | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Grade 3 TEAE | 6 Participants |
| Prevenar 13 | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Vaccine-related Grade 3 TEAE | 0 Participants |
| Prevenar 13 | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Vaccine related Grade 5 TEAE | 0 Participants |
| Prevenar 13 | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Any treatment-emergent adverse event (TEAE) | 189 Participants |
| Prevenar 13 | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Any vaccine-related TEAE | 0 Participants |
| Prevenar 13 | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Grade 4 TEAE | 0 Participants |
| Prevenar 13 | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | Grade 1 TEAE | 186 Participants |
| Prevenar 13 | Number of Participants With Unsolicited Treatment-emergent Adverse Events (TEAEs) | TEAEs leading to study discontinuation | 1 Participants |
Secondary
Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations
The IgG antibody concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected 4 weeks after the second primary vaccination dose.
Time frame: 4 weeks after completion of primary vaccinations (at age 18 weeks)
Population: Primary Per Protocol Immunogenicity Population with available serotype data
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Pneumosil | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 1 | 3.63 μg/mL |
| Pneumosil | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 5 | 1.19 μg/mL |
| Pneumosil | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 6A | 1.19 μg/mL |
| Pneumosil | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 6B | 1.82 μg/mL |
| Pneumosil | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 7F | 3.46 μg/mL |
| Pneumosil | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 9V | 1.93 μg/mL |
| Pneumosil | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 14 | 4.03 μg/mL |
| Pneumosil | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 19A | 1.75 μg/mL |
| Pneumosil | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 19F | 5.45 μg/mL |
| Pneumosil | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 23F | 2.21 μg/mL |
| Synflorix | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 19F | 8.86 μg/mL |
| Synflorix | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 1 | 1.36 μg/mL |
| Synflorix | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 9V | 1.31 μg/mL |
| Synflorix | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 7F | 1.73 μg/mL |
| Synflorix | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 5 | 0.87 μg/mL |
| Synflorix | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 23F | 0.57 μg/mL |
| Synflorix | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 19A | 0.65 μg/mL |
| Synflorix | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 6A | 0.14 μg/mL |
| Synflorix | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 14 | 2.58 μg/mL |
| Synflorix | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 6B | 0.91 μg/mL |
| Prevenar 13 | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 19A | 4.38 μg/mL |
| Prevenar 13 | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 6B | 1.75 μg/mL |
| Prevenar 13 | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 7F | 4.67 μg/mL |
| Prevenar 13 | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 9V | 2.56 μg/mL |
| Prevenar 13 | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 19F | 9.06 μg/mL |
| Prevenar 13 | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 14 | 3.27 μg/mL |
| Prevenar 13 | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 1 | 3.40 μg/mL |
| Prevenar 13 | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 23F | 1.64 μg/mL |
| Prevenar 13 | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 5 | 1.81 μg/mL |
| Prevenar 13 | Geometric Mean Concentration of Serotype-specific IgG Antibodies Four Weeks After Completion of Primary Vaccinations | Serotype 6A | 2.62 μg/mL |
Secondary
Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster
The IgG antibody concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected immediately prior to the booster vaccination dose.
Time frame: Prior to the booster dose at approximately 9 to 16 months of age
Population: Primary Per Protocol Immunogenicity population with available serotype data
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Pneumosil | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 1 | 0.36 μg/mL |
| Pneumosil | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 5 | 0.17 μg/mL |
| Pneumosil | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 6A | 0.62 μg/mL |
| Pneumosil | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 6B | 0.97 μg/mL |
| Pneumosil | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 7F | 0.60 μg/mL |
| Pneumosil | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 9V | 0.25 μg/mL |
| Pneumosil | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 14 | 0.71 μg/mL |
| Pneumosil | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 19A | 0.49 μg/mL |
| Pneumosil | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 19F | 0.83 μg/mL |
| Pneumosil | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 23F | 0.32 μg/mL |
| Synflorix | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 19F | 1.25 μg/mL |
| Synflorix | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 1 | 0.16 μg/mL |
| Synflorix | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 9V | 0.29 μg/mL |
| Synflorix | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 7F | 0.43 μg/mL |
| Synflorix | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 5 | 0.16 μg/mL |
| Synflorix | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 23F | 0.16 μg/mL |
| Synflorix | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 19A | 0.40 μg/mL |
| Synflorix | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 6A | 0.22 μg/mL |
| Synflorix | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 14 | 0.48 μg/mL |
| Synflorix | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 6B | 0.56 μg/mL |
| Prevenar 13 | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 19A | 0.53 μg/mL |
| Prevenar 13 | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 6B | 0.45 μg/mL |
| Prevenar 13 | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 7F | 0.72 μg/mL |
| Prevenar 13 | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 9V | 0.28 μg/mL |
| Prevenar 13 | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 19F | 0.72 μg/mL |
| Prevenar 13 | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 14 | 1.16 μg/mL |
| Prevenar 13 | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 1 | 0.37 μg/mL |
| Prevenar 13 | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 23F | 0.17 μg/mL |
| Prevenar 13 | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 5 | 0.24 μg/mL |
| Prevenar 13 | Geometric Mean Concentration of Serotype-specific Serum IgG Antibodies Prior to Booster | Serotype 6A | 0.50 μg/mL |
Secondary
Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster
Opsonophagocytic activity was measured using the 4-fold multiplexed opsonophagocytic assay (MOPA) from serum samples collected immediately prior to the booster vaccination dose.
Time frame: Prior to the booster dose at approximately 9 to 16 months of age
Population: Primary Per Protocol Immunogenicity population with available serotype data; OPA assays were conducted on the first 50 samples from each treatment group.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Pneumosil | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 19A | 13.43 titer |
| Pneumosil | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 7F | 1756.80 titer |
| Pneumosil | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 23F | 65.62 titer |
| Pneumosil | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 14 | 60.53 titer |
| Pneumosil | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 9V | 27.60 titer |
| Pneumosil | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 6A | 42.59 titer |
| Pneumosil | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 5 | 12.53 titer |
| Pneumosil | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 19F | 24.09 titer |
| Pneumosil | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 6B | 121.60 titer |
| Pneumosil | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 1 | 5.57 titer |
| Synflorix | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 9V | 27.95 titer |
| Synflorix | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 5 | 12.01 titer |
| Synflorix | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 6A | 6.41 titer |
| Synflorix | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 6B | 40.08 titer |
| Synflorix | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 7F | 1725.63 titer |
| Synflorix | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 1 | 5.19 titer |
| Synflorix | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 14 | 17.67 titer |
| Synflorix | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 19A | 12.88 titer |
| Synflorix | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 19F | 57.66 titer |
| Synflorix | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 23F | 41.99 titer |
| Prevenar 13 | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 6B | 32.27 titer |
| Prevenar 13 | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 1 | 5.45 titer |
| Prevenar 13 | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 19A | 28.20 titer |
| Prevenar 13 | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 6A | 40.66 titer |
| Prevenar 13 | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 23F | 81.42 titer |
| Prevenar 13 | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 19F | 12.27 titer |
| Prevenar 13 | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 9V | 48.64 titer |
| Prevenar 13 | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 7F | 1688.30 titer |
| Prevenar 13 | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 5 | 16.03 titer |
| Prevenar 13 | Geometric Mean Titer of Serotype-specific Serum OPA Prior to Booster | Serotype 14 | 62.77 titer |
Secondary
Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster
The functional activity of the antibody response to the 10 serotypes contained in Pneumosil was determined in serum samples collected 4 weeks after the booster dose in a subset of 50 participants per group. This activity was determined using the 4-fold multiplexed opsonophagocytic assay (MOPA) developed at the University of Alabama at Birmingham, and performed at the WHO Pneumococcal Serology Reference Laboratory, at the Institute of Child Health, University College London, UK, where the assay was validated. A higher titer indicates increased antibody-mediated opsonophagocytosis.
Time frame: 4 weeks post booster dose
Population: Primary Per Protocol Immunogenicity population with available serotype data; OPA assays were conducted on the first 50 samples from each treatment group.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Pneumosil | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 1 | 631.29 titer |
| Pneumosil | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 5 | 885.98 titer |
| Pneumosil | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 6A | 3651.54 titer |
| Pneumosil | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 6B | 3931.21 titer |
| Pneumosil | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 7F | 7053.37 titer |
| Pneumosil | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 9V | 1408.68 titer |
| Pneumosil | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 14 | 2622.36 titer |
| Pneumosil | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 19A | 1620.76 titer |
| Pneumosil | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 19F | 1384.38 titer |
| Pneumosil | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 23F | 2998.53 titer |
| Synflorix | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 19F | 2541.40 titer |
| Synflorix | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 1 | 282.35 titer |
| Synflorix | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 9V | 845.47 titer |
| Synflorix | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 7F | 4401.18 titer |
| Synflorix | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 5 | 484.66 titer |
| Synflorix | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 23F | 1427.66 titer |
| Synflorix | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 19A | 305.46 titer |
| Synflorix | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 6A | 53.86 titer |
| Synflorix | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 14 | 1381.52 titer |
| Synflorix | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 6B | 1294.61 titer |
| Prevenar 13 | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 19A | 3679.06 titer |
| Prevenar 13 | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 6B | 6012.88 titer |
| Prevenar 13 | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 7F | 8288.88 titer |
| Prevenar 13 | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 9V | 2464.43 titer |
| Prevenar 13 | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 19F | 2094.57 titer |
| Prevenar 13 | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 14 | 3131.96 titer |
| Prevenar 13 | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 1 | 429.13 titer |
| Prevenar 13 | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 23F | 5687.60 titer |
| Prevenar 13 | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 5 | 703.15 titer |
| Prevenar 13 | Geometric Mean Titers (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) Four Weeks Post-Booster | Serotype 6A | 6464.88 titer |
Secondary
Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations
Opsonophagocytic activity was measured using the 4-fold multiplexed opsonophagocytic assay (MOPA).
Time frame: 4 weeks after completion of primary vaccinations (at age 18 weeks)
Population: Primary Per Protocol Immunogenicity population with available serotype data; OPA assays were conducted on the first 50 samples from each treatment group.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Pneumosil | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 19A | 69.15 titer |
| Pneumosil | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 5 | 182.18 titer |
| Pneumosil | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 6A | 400.49 titer |
| Pneumosil | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 6B | 923.86 titer |
| Pneumosil | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 7F | 2069.84 titer |
| Pneumosil | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 9V | 134.50 titer |
| Pneumosil | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 14 | 669.79 titer |
| Pneumosil | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 19F | 381.46 titer |
| Pneumosil | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 23F | 806.12 titer |
| Pneumosil | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 1 | 99.67 titer |
| Synflorix | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 6B | 166.74 titer |
| Synflorix | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 19F | 690.36 titer |
| Synflorix | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 7F | 1096.84 titer |
| Synflorix | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 9V | 58.24 titer |
| Synflorix | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 14 | 577.98 titer |
| Synflorix | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 1 | 26.70 titer |
| Synflorix | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 19A | 22.40 titer |
| Synflorix | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 5 | 85.09 titer |
| Synflorix | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 6A | 5.35 titer |
| Synflorix | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 23F | 180.97 titer |
| Prevenar 13 | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 14 | 489.56 titer |
| Prevenar 13 | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 6B | 920.43 titer |
| Prevenar 13 | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 5 | 291.98 titer |
| Prevenar 13 | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 1 | 98.63 titer |
| Prevenar 13 | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 7F | 3069.95 titer |
| Prevenar 13 | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 19F | 647.79 titer |
| Prevenar 13 | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 19A | 324.64 titer |
| Prevenar 13 | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 9V | 331.79 titer |
| Prevenar 13 | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 23F | 748.96 titer |
| Prevenar 13 | Geometric Mean Titers of Serotype-specific Serum OPA Four Weeks After Primary Vaccinations | Serotype 6A | 1524.31 titer |
Secondary
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations
The seroresponse rate was defined as the percentage of infants with serotype-specific IgG antibody concentrations of at least 0.35 μg/mL, which is the reference concentration for assessment of vaccine efficacy against invasive pneumococcal diseases (IPDs). The IgG concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected 4 weeks after the second primary vaccination dose.
Time frame: 4 weeks after completion of primary vaccinations (at age 18 weeks)
Population: Primary Per Protocol Immunogenicity population with available serotype data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Serotype 1 | 99.5 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Serotype 5 | 96.8 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Serotype 6A | 83.3 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Serotype 6B | 84.7 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Serotype 7F | 99.5 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Seroytpe 9V | 94.9 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Serotype 14 | 98.6 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Serotype 19A | 97.7 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Serotype 19F | 100 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Serotype 23F | 95.8 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Serotype 19F | 99.5 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Serotype 1 | 96.2 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Seroytpe 9V | 91.0 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Serotype 7F | 97.2 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Serotype 5 | 92.0 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Serotype 23F | 63.2 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Serotype 19A | 75.2 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Serotype 6A | 12.8 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Serotype 14 | 95.3 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Serotype 6B | 71.2 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Serotype 19A | 97.6 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Serotype 6B | 89.0 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Serotype 7F | 100 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Seroytpe 9V | 98.1 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Serotype 19F | 100 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Serotype 14 | 97.2 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Serotype 1 | 100 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Serotype 23F | 89.6 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Serotype 5 | 96.2 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks After Completion of Primary Vaccinations | Serotype 6A | 91.5 percentage of participants |
Secondary
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster
The seroresponse rate was defined as the percentage of infants with serotype-specific IgG antibody concentrations of at least 0.35 μg/mL, which is the reference concentration for assessment of vaccine efficacy against invasive pneumococcal diseases (IPDs). The IgG concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected 4 weeks after the booster dose.
Time frame: 4 weeks post booster dose
Population: Primary Per Protocol Immunogenicity population with available serotype data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 1 | 100 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 5 | 97.5 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 6A | 98.0 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 6B | 100 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 7F | 100 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 9V | 99.0 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 14 | 98.5 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 19A | 100 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 19F | 100 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 23F | 98.0 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 7F | 99.5 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 1 | 100 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 9V | 99.5 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 23F | 98.0 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 5 | 89.9 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 19F | 100 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 19A | 91.5 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 6A | 66.2 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 14 | 97.5 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 6B | 99.5 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 23F | 98.5 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 6B | 99.5 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 7F | 100 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 19F | 100 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 9V | 100 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 14 | 99.5 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 1 | 99.5 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 5 | 99.0 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 19A | 100 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 0.35 μg/mL Four Weeks Post-Booster | Serotype 6A | 99.0 percentage of participants |
Secondary
Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster
Seroresponse rate was also defined as the percentage of infants with serotype-specific IgG antibody concentrations of at least 1.0 μg/mL. The IgG concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected 4 weeks after the booster dose.
Time frame: 4 weeks post booster dose
Population: Primary Per Protocol Immunogenicity population with available data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 19A | 96.0 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 6B | 100 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 19F | 98.5 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 23F | 94.6 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 5 | 68.6 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 1 | 98.5 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 7F | 98.0 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 9V | 94.6 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 14 | 95.0 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 6A | 96.5 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 19A | 77.4 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 7F | 95.0 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 5 | 37.7 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 19F | 96.9 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 6B | 96.5 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 14 | 90.0 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 23F | 83.0 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 9V | 89.5 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 6A | 37.9 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 1 | 88.3 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 6A | 98.0 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 1 | 97.5 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 5 | 87.5 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 6B | 99.5 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 7F | 99.5 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 9V | 95.5 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 14 | 99.0 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 19A | 99.5 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 19F | 99.0 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Antibody Concentrations ≥ 1.0 μg/mL Four Weeks Post-Booster | Serotype 23F | 96.0 percentage of participants |
Secondary
Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster
The seroresponse rate was defined as the percentage of infants with serotype-specific IgG concentrations of at least 0.35 μg/mL, which is the reference concentration for assessment of vaccine efficacy against invasive pneumococcal diseases (IPDs). The IgG concentration to each of the 10 serotypes contained in Pneumosil was measured by ELISA in serum samples collected immediately prior to the booster vaccination dose.
Time frame: Prior to the booster dose at approximately 9 to 16 months of age
Population: Primary Per Protocol Immunogenicity population with available serotype data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 7F | 74.5 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 19A | 58.1 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 1 | 50.2 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 9V | 35.1 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 14 | 69.6 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 23F | 46.2 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 6A | 76.0 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 5 | 13.7 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 19F | 84.1 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 6B | 89.9 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 14 | 59.3 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 1 | 17.2 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 5 | 16.4 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 6A | 32.7 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 6B | 74.6 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 19A | 54.9 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 19F | 95.1 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 23F | 19.4 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 7F | 65.4 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 9V | 36.1 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 6A | 70.4 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 1 | 53.4 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 19F | 80.6 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 5 | 33.8 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 9V | 37.7 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 7F | 84.5 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 14 | 86.3 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 6B | 60.7 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 23F | 24.9 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum IgG Concentrations ≥ 0.35 μg/mL Prior to Booster | Serotype 19A | 65.7 percentage of participants |
Secondary
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations
The OPA seroresponse rate was defined as the percentage of infants with an OPA titer of at least 8. Opsonophagocytic activity was measured using the 4-fold multiplexed opsonophagocytic assay (MOPA).
Time frame: 4 weeks after completion of primary vaccinations (at age 18 weeks)
Population: Primary Per Protocol Immunogenicity population with available serotype data; OPA assays were conducted on the first 50 samples from each treatment group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 9V | 100 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 5 | 98.0 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 6A | 92.0 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 6B | 96.0 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 7F | 100 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 14 | 94.0 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 19A | 91.8 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 19F | 96.0 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 23F | 100 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 1 | 98.0 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 14 | 97.9 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 1 | 73.5 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 9V | 100 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 7F | 100 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 5 | 96.0 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 23F | 100 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 19F | 95.9 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 6A | 10.2 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 19A | 56.5 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 6B | 69.4 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 19F | 98.0 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 6B | 92.0 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 7F | 100 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 9V | 100 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 14 | 90.0 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 23F | 100 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 19A | 96.0 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 1 | 96.0 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 5 | 100 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks After Completion of Primary Vaccinations | Serotype 6A | 98.0 percentage of participants |
Secondary
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster
The OPA seroresponse rate was defined as the percentage of infants with an OPA titer of at least 8. Opsonophagocytic activity was measured using the 4-fold multiplexed opsonophagocytic assay (MOPA) from serum samples taken 4 weeks after the booster vaccination.
Time frame: 4 weeks post booster dose
Population: Primary Per Protocol Immunogenicity population with available serotype data; OPA assays were conducted on the first 50 samples from each treatment group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 1 | 100 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 5 | 100 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 6A | 100 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 6B | 100 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 7F | 100 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 9V | 100 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 14 | 100 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 19A | 100 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 19F | 98.0 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 23F | 100 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 19F | 98.0 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 1 | 96.0 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 9V | 100 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 7F | 100 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 5 | 100 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 23F | 100 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 19A | 90.0 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 6A | 55.6 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 14 | 96.0 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 6B | 98.0 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 19A | 100 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 6B | 98.0 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 7F | 100 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 9V | 100 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 19F | 98.0 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 14 | 100 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 1 | 98.0 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 23F | 100 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 5 | 100 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Four Weeks Post-Booster | Serotype 6A | 100 percentage of participants |
Secondary
Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster
The OPA seroresponse rate was defined as the percentage of infants with an OPA titer of at least 8. Opsonophagocytic activity was measured using the 4-fold multiplexed opsonophagocytic assay (MOPA) from serum samples collected immediately prior to the booster vaccination dose.
Time frame: Prior to the booster dose at approximately 9 to 16 months of age
Population: Primary Per Protocol Immunogenicity population with available serotype data; OPA assays were conducted on the first 50 samples from each treatment group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 1 | 22.4 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 5 | 58.3 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 6A | 76.6 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 6B | 87.5 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 7F | 100 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 9V | 100 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 14 | 75.5 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 19A | 35.4 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 19F | 60.4 percentage of participants |
| Pneumosil | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 23F | 100 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 19F | 79.6 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 1 | 16.0 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 9V | 100 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 7F | 100 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 5 | 49.0 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 23F | 100 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 19A | 40.8 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 6A | 14.0 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 14 | 52.1 percentage of participants |
| Synflorix | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 6B | 62.5 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 19A | 63.3 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 6B | 54.2 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 7F | 100 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 9V | 100 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 19F | 36.7 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 14 | 72.9 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 1 | 25.5 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 23F | 100 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 5 | 63.3 percentage of participants |
| Prevenar 13 | Percentage of Participants With Serotype-specific Serum OPA Titers ≥ 8 Prior to Booster | Serotype 6A | 63.8 percentage of participants |
Secondary
Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations
Booster response was measured by the ratio of IgG GMCs measured at the post-booster visit to those measured 4 weeks after completion of primary vaccinations.
Time frame: 4 weeks after completion of primary vaccinations (at age 18 weeks) and 4 weeks post booster
Population: Primary Per Protocol Immunogenicity population with available data for each serotype at both time points
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Pneumosil | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 19A | 4.98 ratio |
| Pneumosil | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 6B | 6.71 ratio |
| Pneumosil | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 19F | 1.98 ratio |
| Pneumosil | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 23F | 2.24 ratio |
| Pneumosil | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 5 | 1.29 ratio |
| Pneumosil | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 1 | 2.31 ratio |
| Pneumosil | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 7F | 1.91 ratio |
| Pneumosil | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 6A | 7.86 ratio |
| Pneumosil | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 9V | 1.76 ratio |
| Pneumosil | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 14 | 1.98 ratio |
| Synflorix | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 19A | 3.69 ratio |
| Synflorix | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 7F | 1.84 ratio |
| Synflorix | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 14 | 1.93 ratio |
| Synflorix | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 19F | 1.96 ratio |
| Synflorix | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 6B | 5.32 ratio |
| Synflorix | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 5 | 0.90 ratio |
| Synflorix | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 23F | 3.67 ratio |
| Synflorix | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 9V | 1.86 ratio |
| Synflorix | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 6A | 4.30 ratio |
| Synflorix | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 1 | 2.09 ratio |
| Prevenar 13 | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 9V | 1.55 ratio |
| Prevenar 13 | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 5 | 1.15 ratio |
| Prevenar 13 | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 6A | 4.14 ratio |
| Prevenar 13 | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 6B | 8.92 ratio |
| Prevenar 13 | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 7F | 1.36 ratio |
| Prevenar 13 | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 1 | 1.74 ratio |
| Prevenar 13 | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 14 | 2.80 ratio |
| Prevenar 13 | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 19A | 2.69 ratio |
| Prevenar 13 | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 19F | 1.68 ratio |
| Prevenar 13 | Ratio of Serotype-specific Serum IgG GMC 4 Weeks Post-Booster to Serotype-specific IgG GMC 4 Weeks After Completion of Primary Vaccinations | Serotype 23F | 3.00 ratio |
Secondary
Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations
OPA booster response was measured by the ratio of OPA GMTs measured at the post-booster visit to those measured 4 weeks after completion of primary vaccinations.
Time frame: 4 weeks after completion of primary vaccinations (at age 18 weeks) and 4 weeks post booster
Population: Primary Per Protocol Immunogenicity population with available data for each serotype at both time points; OPA assays were conducted on the first 50 samples from each treatment group.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Pneumosil | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 1 | 6.70 ratio |
| Pneumosil | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 5 | 4.91 ratio |
| Pneumosil | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 6A | 10.36 ratio |
| Pneumosil | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 6B | 4.62 ratio |
| Pneumosil | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 7F | 3.51 ratio |
| Pneumosil | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 9V | 10.24 ratio |
| Pneumosil | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 14 | 4.27 ratio |
| Pneumosil | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 19A | 23.79 ratio |
| Pneumosil | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 19F | 3.74 ratio |
| Pneumosil | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 23F | 3.81 ratio |
| Synflorix | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 9V | 14.90 ratio |
| Synflorix | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 1 | 9.35 ratio |
| Synflorix | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 7F | 4.03 ratio |
| Synflorix | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 23F | 8.71 ratio |
| Synflorix | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 5 | 5.36 ratio |
| Synflorix | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 19F | 3.30 ratio |
| Synflorix | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 19A | 12.25 ratio |
| Synflorix | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 6A | 10.12 ratio |
| Synflorix | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 14 | 2.25 ratio |
| Synflorix | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 6B | 7.70 ratio |
| Prevenar 13 | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 19A | 11.63 ratio |
| Prevenar 13 | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 6B | 6.54 ratio |
| Prevenar 13 | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 23F | 7.41 ratio |
| Prevenar 13 | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 7F | 2.71 ratio |
| Prevenar 13 | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 9V | 7.64 ratio |
| Prevenar 13 | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 19F | 3.55 ratio |
| Prevenar 13 | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 14 | 5.73 ratio |
| Prevenar 13 | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 1 | 4.45 ratio |
| Prevenar 13 | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 5 | 2.46 ratio |
| Prevenar 13 | Ratio of Serotype-specific Serum OPA GMT 4 Weeks Post-Booster to Serotype-specific OPA GMT 4 Weeks After Completion of Primary Vaccinations | Serotype 6A | 3.89 ratio |