Pneumococcal Disease
Conditions
Brief summary
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants
Interventions
BIOLOGICAL20-valent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine
BIOLOGICAL13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
Sponsors
Pfizer
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 112 Days
Healthy volunteers
Yes
Inclusion criteria
* Male or female infants born at \>36 weeks of gestation and 2 months of age at the time of consent. * Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
Exclusion criteria
* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis). * Major known congenital malformation or serious chronic disorder. * Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. * Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | 1 month after Dose 3 | Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F and additional serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. Assay results below the LLOQ were set to 0.5 \* LLOQ. GMC and corresponding 2-sided 95% CIs were calculated by exponentiating mean logarithm of concentration, and the corresponding 2-sided 95% CIs (based on Student's t distribution). |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort | Within 7 Days after Dose 2 | Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: temperature \>=38.0 degree C and categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper & Pearson method. |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort | Within 7 Days after Dose 3 | Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: temperature \>=38.0 degree C and categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper & Pearson method. |
| Percentage of Participants With AEs From Dose 1 to 1 Month After Dose 2: Russian Cohort | From Dose 1 to 1 month after Dose 2 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events collected from an e-diary. |
| Percentage of Participants With AEs From Dose 3 to 1 Month After Dose 3: Russian Cohort | From Dose 3 to 1 month after Dose 3 | An AE was any untoward medical occurrence in a participants, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events collected from an e-diary. |
| Percentage of Participants With SAEs From Dose 1 to 1 Month After Dose 3: Russian Cohort | From Dose 1 to 1 month after Dose 3 | A SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method. |
| Percentage of Participants With NDCMC From Dose 1 to 1 Month After Dose 3: Russian Cohort | From Dose 1 to 1 month after Dose 3 | A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. 95% CI was based on the Clopper and Pearson method. |
| Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | 1 month after Dose 2 | Predefined IgG concentrations were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: \>=0.35 mcg/mL, for serotype 5: \>=0.23 mcg/mL, for serotype 6B. \>=0.10 mcg/mL and for serotype 19A: \>=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method. |
| GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | 1 month after Dose 2 | Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F and 7 additional serotypes: 8, 10A, 11A, 12F, 15B, 22F, 33F. Assay results below the LLOQ were set to 0.5 \* LLOQ. GMC and corresponding 2-sided 95% CIs were calculated by exponentiating mean logarithm of concentration, and the corresponding 2-sided 95% CIs (based on Student's t distribution). |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population | Within 7 days after Dose 1 | Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than \[\>\] 0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95 percent (%) confidence interval (CI) was based on Clopper and Pearson method. |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population | Within 7 days after Dose 2 | Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method. |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population | Within 7 days after Dose 3 | Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method. |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population | Within 7 Days after Dose 1 | Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: was defined as temperature \>=38.0 degree Celsius (C) and categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method. |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population | Within 7 Days after Dose 2 | Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using an e-diary. Fever: was defined as temperature \>=38.0 degree C and categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method. |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population | Within 7 Days after Dose 3 | Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: was defined as temperature \>=38.0 degree C and categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) & severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method. |
| Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 2: Primary Study Population | From Dose 1 to 1 month after Dose 2 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events collected from an e-diary. |
| Percentage of Participants With Adverse Events (AEs) From Dose 3 to 1 Month After Dose 3: Primary Study Population | From Dose 3 to 1 month after Dose 3 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events collected from an e-diary. |
| Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 3: Primary Study Population | From Dose 1 to 1 month after Dose 3 | A SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method. |
| Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From Dose 1 to 1 Month After Dose 3: Primary Study Population | From Dose 1 to 1 month after Dose 3 | A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. 95% CI was based on the Clopper and Pearson method. |
| Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | 1 month after Dose 2 | Predefined IgG concentrations were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: \>=0.35 microgram per mL (mcg/mL), for serotype 5: \>=0.23 mcg/mL, for serotype 6B: \>=0.10 mcg/mL and for serotype 19A: \>=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method. |
| Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | 1 month after Dose 2 | Pneumococcal serotype-specific IgG concentration was measured for serum sample for 13vPnC serotype: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 7 additional serotype: 8, 10A, 11A, 12F, 15B, 22F, 33F. GMC and corresponding 2-sided 95% CIs were calculated by exponentiating mean logarithm of concentration, corresponding 2-sided 95% CIs (based on Student's t distribution). Assay result below LLOQ was set to 0.5\*LLOQ. Geometric mean ratios (GMRs) were reported in statistical analysis section and were calculated by exponentiating mean difference of logarithm of concentration and corresponding 2-sided 95% CIs (based on Student's t distribution). |
| GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | 1 month after Dose 3 | Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 7 additional serotype: 8, 10A, 11A, 12F, 15B, 22F,33F. GMC and corresponding 2-sided 95% CI were calculated by exponentiating mean logarithm of concentrations and corresponding 2-sided 95% CI (based on Student's t distribution). Assay result below LLOQ were set to 0.5\*LLOQ. GMRs were reported in statistical analysis section and were calculated by exponentiating mean difference of logarithm of concentration and corresponding 2-sided 95% CI (based on Student's t distribution). |
| Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population | 1 month after Dose 3 | Diphtheria and tetanus toxoids: concentration of antibody (AB) (in international units \[IU\]) to diphtheria & tetanus toxoid (prespecified level\>=0.1 IU/mL); Pertussis antigens-pertussis toxin (PT), filamentous hemagglutinin (FHA), pertactin (PRN): prespecified level \>=observed Anti pertussis Antibody concentration achieved by 95% of 13vPnC recipient; HBsAg prespecified level \>=10 milli-IU per mL (mIU/mL); Poliovirus strains (types 1, 2 and 3): prespecified level: \>=1:8; Hemophilus influenzae type b(Hib): prespecified level \>=0.15 microgram per millilitre (mcg/mL) polyribosylribitol phosphate (anti-PRP) in mcg/mL. Concomitant vaccine response was assessed from subset of randomly selected study participants. |
| GMC of Measles Virus Antibody 1 Month After Dose 3: Primary Study Population | 1 month after Dose 3 | Pre-specified vaccine antigen (measles) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants. |
| GMC of Mumps Virus Antibody 1 Month After Dose 3: Primary Study Population | 1 month after Dose 3 | Pre-specified vaccine antigen (mumps) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants. |
| GMC of Rubella Virus Antibody 1 Month After Dose 3: Primary Study Population | 1 month after Dose 3 | Pre-specified vaccine antigen (rubella) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below LLOQ were set to 0.5\*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants. |
| GMC of Varicella Virus Antibody 1 Month After Dose 3: Primary Study Population | 1 month after Dose 3 | Pre-specified vaccine antigen (varicella) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants. |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort | Within 7 days after Dose 1 | Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0 to 2.0 cm), moderate (\> 2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method. |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort | Within 7 days after Dose 2 | Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0 to 2.0 cm), moderate (\> 2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method. |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort | Within 7 days after Dose 3 | Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0 to 2.0 cm), moderate (\> 2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method. |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort | Within 7 Days after Dose 1 | Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using e-diary. Fever: temperature \>=38.0 degree C & categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0-degree C. Decreased appetite: was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper & Pearson method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | 1 month after Dose 2 | OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomly selected subsets of participants at 1 month after Dose 2. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the Student's t distribution. |
| Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | 1 Month after Dose 3 | OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomly selected subsets of participants at 1 month after Dose 3. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the Student's t distribution. |
| Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Before Dose 3 to 1 month after Dose 3 | 20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student's t distribution). |
| Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population | 1 month after Dose 2 | Pre-specified vaccines were administered concomitantly with 20vPnC or 13vPnC and responses assessed using pre-defined levels as follows: Diphtheria and tetanus toxoids: concentration of antibody (in international units \[IU\]) to diphtheria and tetanus toxoid (prespecified level \>= observed anti-pertussis antibody concentration achieved by 95% of 13vPnC recipients); Poliomyelitis: NA titers to poliovirus types 1, 2, and 3 (prespecified level NA titer \>=1:8); and Hib: concentration of antibody to Hib (PRP) in mcg/mL (prespecified level \>=0.15 mcg/mL anti-PRP). 2-sided 95% CI was based on Clopper and Pearson method. The assays were performed on randomly selected subsets. |
| Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | 1 Month after Dose 3 | Predefined IgG concentrations were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: \>=0.35 mcg/mL, for serotype 5: \>=0.23 mcg/mL, for serotype 6B: \>=0.10 mcg/mL and for serotype 19A: \>=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method. |
| GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | 1 month after Dose 2 | OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomly selected subsets of participants at 1 month after Dose 2. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the student's t distribution. |
| GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | 1 Month after Dose 3 | OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomly selected subsets of participants at 1 month after Dose 3. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the student's t distribution. |
| Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | 1 Month after Dose 3 | Predefined IgG concentrations were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: \>=0.35 mcg/mL, for serotype 5: \>=0.23 mcg/mL, for serotype 6B: \>=0.10 mcg/mL and for serotype 19A: \>=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method. |
Countries
Australia, Belgium, Czechia, Denmark, Estonia, Finland, Italy, Netherlands, Norway, Poland, Russia, Slovakia
Participant flow
Pre-assignment details
For primary study population,1207 participants were enrolled and assigned to receive 3 doses of 20-valent pneumococcal conjugate vaccine (20vPnC) or 13-valent pneumococcal conjugate vaccine (13vPnC) of which 3 participants were not vaccinated, 1204 were vaccinated with 20vPnC or 13vPnC.Additional 51 Russian participants were enrolled, all of whom were vaccinated with 20vPnC or 13vPnC.
Participants by arm
| Arm | Count |
|---|---|
| 20vPnC: Primary Study Population Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 millilitre (mL) 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age. | 601 |
| 13vPnC: Primary Study Population Infants 42 to 112 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 42 to 63 days after dose 1 and dose 3 was administered at 11 to 12 months of age. | 603 |
| 20vPnC: Russian Cohort Infants 42 to 70 days of age were enrolled to receive 3 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 60 to 90 days after dose 1 and dose 3 was administered at 11 to 15 months of age. | 24 |
| 13vPnC: Russian Cohort Infants 42 to 70 days of age were enrolled to receive 3 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was administered at enrollment, dose 2 was given 60 to 90 days after dose 1 and dose 3 was administered at 11 to 15 months of age. | 27 |
| Total | 1,255 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 5 | 4 | 0 | 0 |
| Overall Study | No Longer met eligibility criteria | 3 | 3 | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 1 | 0 | 0 |
| Overall Study | Withdrawal by parent/guardian | 6 | 5 | 1 | 1 |
Baseline characteristics
| Characteristic | 20vPnC: Primary Study Population | 13vPnC: Primary Study Population | 20vPnC: Russian Cohort | 13vPnC: Russian Cohort | Total |
|---|---|---|---|---|---|
| Age, Customized 28 days-23 months | 601 Participants | 603 Participants | 24 Participants | 27 Participants | 1255 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 1 Participants | 0 Participants | 0 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 577 Participants | 586 Participants | 22 Participants | 25 Participants | 1210 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 20 Participants | 16 Participants | 2 Participants | 2 Participants | 40 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 5 Participants | 0 Participants | 1 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 5 Participants | 0 Participants | 0 Participants | 12 Participants |
| Race (NIH/OMB) White | 585 Participants | 592 Participants | 24 Participants | 26 Participants | 1227 Participants |
| Sex: Female, Male Female | 302 Participants | 292 Participants | 16 Participants | 12 Participants | 622 Participants |
| Sex: Female, Male Male | 299 Participants | 311 Participants | 8 Participants | 15 Participants | 633 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 601 | 0 / 603 | 0 / 24 | 0 / 27 |
| other Total, other adverse events | 589 / 601 | 593 / 603 | 17 / 24 | 20 / 27 |
| serious Total, serious adverse events | 34 / 601 | 40 / 603 | 0 / 24 | 0 / 27 |
Outcome results
Primary
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population
Pneumococcal serotype-specific IgG concentration was measured for serum sample for 13vPnC serotype: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 7 additional serotype: 8, 10A, 11A, 12F, 15B, 22F, 33F. GMC and corresponding 2-sided 95% CIs were calculated by exponentiating mean logarithm of concentration, corresponding 2-sided 95% CIs (based on Student's t distribution). Assay result below LLOQ was set to 0.5\*LLOQ. Geometric mean ratios (GMRs) were reported in statistical analysis section and were calculated by exponentiating mean difference of logarithm of concentration and corresponding 2-sided 95% CIs (based on Student's t distribution).
Time frame: 1 month after Dose 2
Population: Dose 2 evaluable immunogenicity population: eligible participants 42-112 days of age at first vaccination, received 1st 2 doses as randomized, at least 1 valid immunogenicity result from blood collection (27-56 days after Dose2). Number of Participants Analyzed=participants in Dose 2 evaluable immunogenicity population, Number Analyzed= participants with valid IgG assay result for specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 20vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 1 | 0.57 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 3 | 0.41 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 4 | 0.55 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 5 | 0.34 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 6A | 0.45 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 6B | 0.03 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 7F | 1.02 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 9V | 0.45 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 14 | 1.05 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 18C | 0.69 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 19A | 0.67 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 19F | 2.21 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 23F | 0.13 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 8 | 1.62 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 10A | 0.16 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 11A | 1.62 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 12F | 0.15 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 15B | 3.33 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 22F | 2.25 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 33F | 0.31 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 15B | 0.04 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 1 | 0.93 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 19A | 1.13 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 3 | 0.58 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 11A | 0.02 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 4 | 0.92 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 19F | 3.06 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 5 | 0.56 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 33F | 0.03 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 6A | 0.84 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 23F | 0.25 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 6B | 0.06 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 12F | 0.01 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 7F | 1.41 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 8 | 0.02 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 9V | 0.77 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 22F | 0.01 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 14 | 1.28 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 10A | 0.02 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Primary Study Population | Serotype 18C | 0.87 Microgram per millilitre (mcg/mL) |
Comparison: Serotype 195% CI: [0.54, 0.69]
Comparison: Serotype 395% CI: [0.64, 0.79]
Comparison: Serotype 495% CI: [0.52, 0.69]
Comparison: Serotype 595% CI: [0.52, 0.7]
Comparison: Serotype 6A95% CI: [0.45, 0.65]
Comparison: Serotype 6B95% CI: [0.43, 0.61]
Comparison: Serotype 7F95% CI: [0.64, 0.8]
Comparison: Serotype 9V95% CI: [0.5, 0.69]
Comparison: Serotype 1495% CI: [0.7, 0.96]
Comparison: Serotype 18C95% CI: [0.67, 0.92]
Comparison: Serotype 19A95% CI: [0.51, 0.69]
Comparison: Serotype 19F95% CI: [0.64, 0.82]
Comparison: Serotype 23F95% CI: [0.44, 0.62]
Comparison: Serotype 895% CI: [22.98, 30.67]
Comparison: Serotype 10A95% CI: [2.25, 3.17]
Comparison: Serotype 11A95% CI: [22.95, 30.82]
Comparison: Serotype 12F95% CI: [2.08, 2.97]
Comparison: Serotype 15B95% CI: [46.35, 64.3]
Comparison: Serotype 22F95% CI: [31.57, 42.89]
Comparison: Serotype 33F95% CI: [4.27, 5.92]
Primary
GMC of Measles Virus Antibody 1 Month After Dose 3: Primary Study Population
Pre-specified vaccine antigen (measles) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants.
Time frame: 1 month after Dose 3
Population: Dose 3 evaluable immunogenicity population = eligible participants 42-112 days of age at first vaccination, received all 3 doses as randomized with 335-386 days of age at Dose 3, at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, no major protocol deviations. Here, Number of Participants Analyzed= participants in Dose 3 evaluable immunogenicity population, received measles vaccine and had valid assay results for measle vaccine antigen.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 20vPnC: Primary Study Population | GMC of Measles Virus Antibody 1 Month After Dose 3: Primary Study Population | 228.63 Arbitrary units per millilitre | 95% Confidence Interval 186.34 |
| 13vPnC: Primary Study Population | GMC of Measles Virus Antibody 1 Month After Dose 3: Primary Study Population | 216.72 Arbitrary units per millilitre | 95% Confidence Interval 174.92 |
Comparison: Measles95% CI: [0.79, 1.42]
Primary
GMC of Mumps Virus Antibody 1 Month After Dose 3: Primary Study Population
Pre-specified vaccine antigen (mumps) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants.
Time frame: 1 month after Dose 3
Population: Dose 3 evaluable immunogenicity population = eligible participants 42-112 days of age at first vaccination, received all 3 doses as randomized with 335-386 days of age at Dose 3, at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, no major protocol deviations. Here, Number of Participants Analyzed= participants in Dose 3 evaluable immunogenicity population, received mumps vaccine and had valid assay results for mumps vaccine antigen.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 20vPnC: Primary Study Population | GMC of Mumps Virus Antibody 1 Month After Dose 3: Primary Study Population | 36.81 Arbitrary units per millilitre | 95% Confidence Interval 29.12 |
| 13vPnC: Primary Study Population | GMC of Mumps Virus Antibody 1 Month After Dose 3: Primary Study Population | 35.25 Arbitrary units per millilitre | 95% Confidence Interval 28.14 |
Comparison: Mumps95% CI: [0.76, 1.44]
Primary
GMC of Rubella Virus Antibody 1 Month After Dose 3: Primary Study Population
Pre-specified vaccine antigen (rubella) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below LLOQ were set to 0.5\*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants.
Time frame: 1 month after Dose 3
Population: Dose 3 evaluable immunogenicity population = eligible participants 42-112 days of age at first vaccination, received all 3 doses as randomized with 335-386 days of age at Dose 3, at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, no major protocol deviations. Here, Number of Participants Analyzed= participants in Dose 3 evaluable immunogenicity population, received rubella vaccine and had valid assay results for rubella vaccine antigen.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 20vPnC: Primary Study Population | GMC of Rubella Virus Antibody 1 Month After Dose 3: Primary Study Population | 31.81 International units per millilitre | 95% Confidence Interval 25.54 |
| 13vPnC: Primary Study Population | GMC of Rubella Virus Antibody 1 Month After Dose 3: Primary Study Population | 38.20 International units per millilitre | 95% Confidence Interval 32.1 |
Comparison: Rubella95% CI: [0.63, 1.1]
Primary
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F and 7 additional serotypes: 8, 10A, 11A, 12F, 15B, 22F, 33F. Assay results below the LLOQ were set to 0.5 \* LLOQ. GMC and corresponding 2-sided 95% CIs were calculated by exponentiating mean logarithm of concentration, and the corresponding 2-sided 95% CIs (based on Student's t distribution).
Time frame: 1 month after Dose 2
Population: Dose 2 evaluable immunogenicity population: eligible participants 42-70days of age at first vaccination, received first 2 doses as randomized, at least 1 valid immunogenicity results within 27 to 56 days after Dose 2, no other major protocol deviations. Number of Participants Analyzed= Participants in Dose 2 evaluable immunogenicity population; Number Analyzed= participants with valid IgG results for specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 1 | 0.76 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.49 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 3 | 0.28 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.19 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 4 | 0.67 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.45 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 5 | 0.53 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.31 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 6A | 0.45 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.2 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 6B | 0.07 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.03 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 7F | 1.06 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.68 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 9V | 0.44 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.23 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 14 | 1.56 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.88 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 18C | 0.94 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.46 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 19A | 1.15 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.47 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 19F | 1.51 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.84 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 23F | 0.25 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.11 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 8 | 0.79 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.37 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 10A | 0.31 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.1 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 11A | 0.83 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.43 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 12F | 0.06 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.03 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 15B | 1.19 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.46 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 22F | 0.48 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.16 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 33F | 0.40 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.18 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 15B | 0.16 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.05 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 1 | 1.04 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.64 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 19A | 1.21 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.59 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 3 | 0.47 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.31 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 11A | 0.04 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.02 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 4 | 1.00 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.58 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 19F | 3.32 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 2.03 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 5 | 0.75 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.4 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 33F | 0.07 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.03 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 6A | 1.57 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.8 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 23F | 0.73 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.37 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 6B | 0.27 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.12 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 12F | 0.02 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.01 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 7F | 1.89 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 1.32 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 8 | 0.07 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.03 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 9V | 1.22 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.73 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 22F | 0.02 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.01 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 14 | 2.66 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 1.46 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 10A | 0.04 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.01 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 18C | 0.94 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.5 |
Primary
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 7 additional serotype: 8, 10A, 11A, 12F, 15B, 22F,33F. GMC and corresponding 2-sided 95% CI were calculated by exponentiating mean logarithm of concentrations and corresponding 2-sided 95% CI (based on Student's t distribution). Assay result below LLOQ were set to 0.5\*LLOQ. GMRs were reported in statistical analysis section and were calculated by exponentiating mean difference of logarithm of concentration and corresponding 2-sided 95% CI (based on Student's t distribution).
Time frame: 1 month after Dose 3
Population: Dose 3 evaluable immunogenicity population (EIP)=eligible participants 42-112 days of age at first vaccination, received all 3 dose as randomized with 335-386 day of age at Dose 3 at least 1 valid immunogenicity results within 27-56 days after Dose 3, no major protocol deviation Number of Participants Analyzed=participants in Dose 3 EIP; Number Analyzed=participants with valid IgG results for specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 19A | 4.51 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 19F | 6.19 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 23F | 2.64 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 8 | 3.57 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 10A | 4.86 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 11A | 3.74 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 12F | 1.86 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 15B | 13.09 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 22F | 9.27 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 33F | 6.37 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 1 | 1.71 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 3 | 0.72 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 4 | 4.11 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 5 | 1.74 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 6A | 7.75 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 6B | 2.64 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 7F | 3.61 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 9V | 3.68 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 14 | 4.52 Microgram per millilitre (mcg/mL) |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 18C | 2.71 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 9V | 5.04 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 19A | 5.49 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 1 | 2.53 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 19F | 8.08 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 6B | 4.63 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 23F | 4.40 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 3 | 1.09 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 8 | 0.03 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 18C | 3.61 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 10A | 0.01 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 4 | 5.36 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 11A | 0.02 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 7F | 4.93 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 12F | 0.01 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 5 | 2.41 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 15B | 0.02 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 14 | 5.66 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 22F | 0.00 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 6A | 11.82 Microgram per millilitre (mcg/mL) |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 33F | 0.01 Microgram per millilitre (mcg/mL) |
Comparison: Serotype 195% CI: [0.6, 0.75]
Comparison: Serotype 395% CI: [0.59, 0.73]
Comparison: Serotype 495% CI: [0.68, 0.87]
Comparison: Serotype 595% CI: [0.64, 0.81]
Comparison: Serotype 6A95% CI: [0.57, 0.75]
Comparison: Serotype 6B95% CI: [0.48, 0.67]
Comparison: Serotype 7F95% CI: [0.67, 0.8]
Comparison: Serotype 9V95% CI: [0.66, 0.81]
Comparison: Serotype 1495% CI: [0.69, 0.92]
Comparison: Serotype 18C95% CI: [0.67, 0.84]
Comparison: Serotype 19A95% CI: [0.72, 0.93]
Comparison: Serotype 19F95% CI: [0.68, 0.87]
Comparison: Serotype 23F95% CI: [0.52, 0.69]
Comparison: Serotype 895% CI: [1.32, 1.66]
Comparison: Serotype 10A95% CI: [1.77, 2.3]
Comparison: Serotype 11A95% CI: [1.37, 1.75]
Comparison: Serotype 12F95% CI: [0.68, 0.87]
Comparison: Serotype 15B95% CI: [4.82, 6.1]
Comparison: Serotype 22F95% CI: [3.4, 4.34]
Comparison: Serotype 33F95% CI: [2.33, 2.99]
Primary
GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F and additional serotypes: 8, 10A, 11A, 12F, 15B, 22F and 33F. Assay results below the LLOQ were set to 0.5 \* LLOQ. GMC and corresponding 2-sided 95% CIs were calculated by exponentiating mean logarithm of concentration, and the corresponding 2-sided 95% CIs (based on Student's t distribution).
Time frame: 1 month after Dose 3
Population: Dose 3 evaluable immunogenicity population = eligible participants 42-70 days of age at first vaccination, received all 3 doses as randomized with 335-455 days of age at Dose 3, at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, no major protocol deviations. Here, Number of Participants Analyzed= participants in Dose 3 evaluable immunogenicity population; Number Analyzed= participants with valid IgG results for specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 1 | 1.61 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.93 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 3 | 0.84 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.44 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 4 | 3.05 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 1.5 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 5 | 1.50 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.8 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 6A | 6.63 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 2.96 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 6B | 1.94 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.82 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 7F | 3.53 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 1.97 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 9V | 2.32 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 1.28 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 14 | 4.01 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 1.64 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 18C | 2.60 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 1.24 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 19A | 4.81 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 2.07 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 19F | 4.97 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 2.3 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 23F | 3.52 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 1.68 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 8 | 1.33 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.5 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 10A | 1.99 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.63 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 11A | 1.50 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.58 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 12F | 0.17 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.05 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 15B | 4.90 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 1.67 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 22F | 1.52 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.38 |
| 20vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 33F | 1.38 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.53 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 15B | 0.07 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.03 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 1 | 1.65 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.94 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 19A | 2.69 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 1.12 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 3 | 0.57 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.32 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 11A | 0.06 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.02 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 4 | 3.04 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 1.72 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 19F | 4.58 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 2.36 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 5 | 1.72 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.9 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 33F | 0.04 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.02 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 6A | 5.63 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 2.96 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 23F | 2.96 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 1.33 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 6B | 1.49 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.67 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 12F | 0.02 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.01 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 7F | 4.14 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 2.73 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 8 | 0.09 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.04 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 9V | 2.27 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 1.19 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 22F | 0.02 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.01 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 14 | 5.06 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 3.04 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 10A | 0.03 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 0.01 |
| 13vPnC: Primary Study Population | GMC of Serotype-specific Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 18C | 2.64 Microgram per millilitre (mcg/mL) | 95% Confidence Interval 1.49 |
Primary
GMC of Varicella Virus Antibody 1 Month After Dose 3: Primary Study Population
Pre-specified vaccine antigen (varicella) was administered concomitantly with 20vPnC or 13vPnC at Dose 3 and responses were measured 1 month after Dose 3. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student's t distribution). The immune responses were only measured on random subset of participants.
Time frame: 1 month after Dose 3
Population: Dose 3 evaluable immunogenicity population = eligible participants 42-112 days of age at first vaccination, received all 3 doses as randomized with 335-386 days of age at Dose 3, at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, no major protocol deviations. Here, Number of Participants Analyzed= participants in Dose 3 evaluable immunogenicity population, received varicella vaccine and had valid assay results varicella vaccine antigen.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 20vPnC: Primary Study Population | GMC of Varicella Virus Antibody 1 Month After Dose 3: Primary Study Population | 195.58 Milli-international units per millilitre | 95% Confidence Interval 165.14 |
| 13vPnC: Primary Study Population | GMC of Varicella Virus Antibody 1 Month After Dose 3: Primary Study Population | 157.60 Milli-international units per millilitre | 95% Confidence Interval 133.57 |
Comparison: Varicella95% CI: [0.98, 1.57]
Primary
Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 2: Primary Study Population
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events collected from an e-diary.
Time frame: From Dose 1 to 1 month after Dose 2
Population: Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| 20vPnC: Primary Study Population | Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 2: Primary Study Population | 13.8 Percentage of participants | 95% Confidence Interval 11.2 |
| 13vPnC: Primary Study Population | Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 2: Primary Study Population | 14.4 Percentage of participants | 95% Confidence Interval 11.7 |
Primary
Percentage of Participants With Adverse Events (AEs) From Dose 3 to 1 Month After Dose 3: Primary Study Population
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events collected from an e-diary.
Time frame: From Dose 3 to 1 month after Dose 3
Population: Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose. Here, Number of Participants Analyzed signifies the number of participants who received Dose 3.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| 20vPnC: Primary Study Population | Percentage of Participants With Adverse Events (AEs) From Dose 3 to 1 Month After Dose 3: Primary Study Population | 15.5 Percentage of participants | 95% Confidence Interval 12.6 |
| 13vPnC: Primary Study Population | Percentage of Participants With Adverse Events (AEs) From Dose 3 to 1 Month After Dose 3: Primary Study Population | 16.5 Percentage of participants | 95% Confidence Interval 13.6 |
Primary
Percentage of Participants With AEs From Dose 1 to 1 Month After Dose 2: Russian Cohort
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events collected from an e-diary.
Time frame: From Dose 1 to 1 month after Dose 2
Population: Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| 20vPnC: Primary Study Population | Percentage of Participants With AEs From Dose 1 to 1 Month After Dose 2: Russian Cohort | 8.3 Percentage of participants | 95% Confidence Interval 1 |
| 13vPnC: Primary Study Population | Percentage of Participants With AEs From Dose 1 to 1 Month After Dose 2: Russian Cohort | 3.7 Percentage of participants | 95% Confidence Interval 0.1 |
Primary
Percentage of Participants With AEs From Dose 3 to 1 Month After Dose 3: Russian Cohort
An AE was any untoward medical occurrence in a participants, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. AEs reported in this outcome measure excluded local reactions and systemic events collected from an e-diary.
Time frame: From Dose 3 to 1 month after Dose 3
Population: Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose. Here, Number of Participants Analyzed signifies the number of participants who received Dose 3.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| 20vPnC: Primary Study Population | Percentage of Participants With AEs From Dose 3 to 1 Month After Dose 3: Russian Cohort | 4.5 Percentage of participants | 95% Confidence Interval 0.1 |
| 13vPnC: Primary Study Population | Percentage of Participants With AEs From Dose 3 to 1 Month After Dose 3: Russian Cohort | 0 Percentage of participants | 95% Confidence Interval 0 |
Primary
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population
Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than \[\>\] 0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95 percent (%) confidence interval (CI) was based on Clopper and Pearson method.
Time frame: Within 7 days after Dose 1
Population: Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose. Here, Number of Participants Analyzed signifies the number of participants with any e-diary data after Dose 1.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population | Redness: Moderate | 4.5 Percentage of participants | 95% Confidence Interval 3 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population | Swelling: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population | Swelling: Mild | 12.7 Percentage of participants | 95% Confidence Interval 10.1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population | Pain at Injection Site: Mild | 16.7 Percentage of participants | 95% Confidence Interval 13.8 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population | Redness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population | Pain at Injection Site: Moderate | 12.0 Percentage of participants | 95% Confidence Interval 9.5 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population | Swelling: Moderate | 8.7 Percentage of participants | 95% Confidence Interval 6.6 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population | Pain at Injection Site: Severe | 0.3 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population | Redness: Mild | 20.7 Percentage of participants | 95% Confidence Interval 17.6 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population | Pain at Injection Site: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population | Redness: Mild | 22.7 Percentage of participants | 95% Confidence Interval 19.4 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population | Redness: Moderate | 4.8 Percentage of participants | 95% Confidence Interval 3.2 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population | Redness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population | Swelling: Mild | 12.9 Percentage of participants | 95% Confidence Interval 10.4 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population | Swelling: Moderate | 7.3 Percentage of participants | 95% Confidence Interval 5.4 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population | Swelling: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population | Pain at Injection Site: Mild | 17.9 Percentage of participants | 95% Confidence Interval 14.9 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Primary Study Population | Pain at Injection Site: Moderate | 11.4 Percentage of participants | 95% Confidence Interval 9 |
Primary
Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort
Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0 to 2.0 cm), moderate (\> 2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method.
Time frame: Within 7 days after Dose 1
Population: Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose. Here, Number of Participants Analyzed signifies number of participants with any e-diary data after Dose 1
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort | Redness: Moderate | 4.2 Percentage of participants | 95% Confidence Interval 0.1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort | Swelling: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort | Swelling: Mild | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort | Pain at Injection Site: Mild | 8.3 Percentage of participants | 95% Confidence Interval 1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort | Redness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort | Pain at Injection Site: Moderate | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort | Swelling: Moderate | 4.2 Percentage of participants | 95% Confidence Interval 0.1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort | Pain at Injection Site: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort | Redness: Mild | 4.2 Percentage of participants | 95% Confidence Interval 0.1 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort | Pain at Injection Site: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort | Redness: Mild | 7.4 Percentage of participants | 95% Confidence Interval 0.9 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort | Redness: Moderate | 3.7 Percentage of participants | 95% Confidence Interval 0.1 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort | Redness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort | Swelling: Mild | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort | Swelling: Moderate | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort | Swelling: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort | Pain at Injection Site: Mild | 7.4 Percentage of participants | 95% Confidence Interval 0.9 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Russian Cohort | Pain at Injection Site: Moderate | 3.7 Percentage of participants | 95% Confidence Interval 0.1 |
Primary
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population
Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method.
Time frame: Within 7 days after Dose 2
Population: Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose. Here, Number of Participants Analyzed signifies the number of participants with any e-diary data after Dose 2.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population | Redness: Moderate | 3.7 Percentage of participants | 95% Confidence Interval 2.3 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population | Swelling: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population | Swelling: Mild | 13.7 Percentage of participants | 95% Confidence Interval 11 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population | Pain at Injection Site: Mild | 13.3 Percentage of participants | 95% Confidence Interval 10.7 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population | Redness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population | Pain at Injection Site: Moderate | 9.3 Percentage of participants | 95% Confidence Interval 7.1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population | Swelling: Moderate | 8.3 Percentage of participants | 95% Confidence Interval 6.2 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population | Pain at Injection Site: Severe | 0.2 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population | Redness: Mild | 24.8 Percentage of participants | 95% Confidence Interval 21.4 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population | Pain at Injection Site: Severe | 0.2 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population | Redness: Mild | 22.9 Percentage of participants | 95% Confidence Interval 19.6 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population | Redness: Moderate | 5.1 Percentage of participants | 95% Confidence Interval 3.4 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population | Redness: Severe | 0.2 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population | Swelling: Mild | 14.1 Percentage of participants | 95% Confidence Interval 11.4 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population | Swelling: Moderate | 6.2 Percentage of participants | 95% Confidence Interval 4.4 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population | Swelling: Severe | 0.2 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population | Pain at Injection Site: Mild | 16.5 Percentage of participants | 95% Confidence Interval 13.6 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Primary Study Population | Pain at Injection Site: Moderate | 7.9 Percentage of participants | 95% Confidence Interval 5.9 |
Primary
Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort
Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0 to 2.0 cm), moderate (\> 2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method.
Time frame: Within 7 days after Dose 2
Population: Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose. Here, Number of Participants Analyzed signifies the number of participants with any e-diary data after Dose 2.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort | Redness: Moderate | 4.3 Percentage of participants | 95% Confidence Interval 0.1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort | Swelling: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort | Swelling: Mild | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort | Pain at Injection Site: Mild | 8.7 Percentage of participants | 95% Confidence Interval 1.1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort | Redness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort | Pain at Injection Site: Moderate | 4.3 Percentage of participants | 95% Confidence Interval 0.1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort | Swelling: Moderate | 8.7 Percentage of participants | 95% Confidence Interval 1.1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort | Pain at Injection Site: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort | Redness: Mild | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort | Pain at Injection Site: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort | Redness: Mild | 3.7 Percentage of participants | 95% Confidence Interval 0.1 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort | Redness: Moderate | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort | Redness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort | Swelling: Mild | 7.4 Percentage of participants | 95% Confidence Interval 0.9 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort | Swelling: Moderate | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort | Swelling: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort | Pain at Injection Site: Mild | 7.4 Percentage of participants | 95% Confidence Interval 0.9 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Russian Cohort | Pain at Injection Site: Moderate | 0 Percentage of participants | 95% Confidence Interval 0 |
Primary
Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population
Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method.
Time frame: Within 7 days after Dose 3
Population: Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose. Here, Number of Participants Analyzed signifies the number of participants with any e-diary data after Dose 3.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population | Redness: Moderate | 13.4 Percentage of participants | 95% Confidence Interval 10.8 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population | Swelling: Severe | 0.2 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population | Swelling: Mild | 17.8 Percentage of participants | 95% Confidence Interval 14.7 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population | Pain at Injection Site: Mild | 24.7 Percentage of participants | 95% Confidence Interval 21.2 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population | Redness: Severe | 0.2 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population | Pain at Injection Site: Moderate | 17.4 Percentage of participants | 95% Confidence Interval 14.4 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population | Swelling: Moderate | 11.9 Percentage of participants | 95% Confidence Interval 9.4 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population | Pain at Injection Site: Severe | 0.3 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population | Redness: Mild | 23.3 Percentage of participants | 95% Confidence Interval 19.9 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population | Pain at Injection Site: Severe | 0.3 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population | Redness: Mild | 25.1 Percentage of participants | 95% Confidence Interval 21.6 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population | Redness: Moderate | 8.5 Percentage of participants | 95% Confidence Interval 6.4 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population | Redness: Severe | 0.2 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population | Swelling: Mild | 14.5 Percentage of participants | 95% Confidence Interval 11.8 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population | Swelling: Moderate | 9.7 Percentage of participants | 95% Confidence Interval 7.5 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population | Swelling: Severe | 0.3 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population | Pain at Injection Site: Mild | 22.4 Percentage of participants | 95% Confidence Interval 19 |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Primary Study Population | Pain at Injection Site: Moderate | 17.2 Percentage of participants | 95% Confidence Interval 14.3 |
Primary
Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort
Local reactions included redness, swelling and, pain at the injection site, recorded by parents/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (\>0 to 2.0 cm), moderate (\> 2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). 95% CI was based on Clopper and Pearson method.
Time frame: Within 7 days after Dose 3
Population: Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose. Here, Number of Participants Analyzed signifies the number of participants with any e-diary data after Dose 3.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort | Redness: Moderate | 4.5 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort | Swelling: Severe | 0 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort | Swelling: Mild | 0 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort | Pain at Injection Site: Mild | 13.6 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort | Redness: Severe | 0 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort | Pain at Injection Site: Moderate | 0 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort | Swelling: Moderate | 9.1 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort | Pain at Injection Site: Severe | 0 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort | Redness: Mild | 0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort | Pain at Injection Site: Severe | 0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort | Redness: Mild | 4.0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort | Redness: Moderate | 0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort | Redness: Severe | 4.0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort | Swelling: Mild | 0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort | Swelling: Moderate | 0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort | Swelling: Severe | 4.0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort | Pain at Injection Site: Mild | 8.0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Russian Cohort | Pain at Injection Site: Moderate | 0 Percentage of participants |
Primary
Percentage of Participants With NDCMC From Dose 1 to 1 Month After Dose 3: Russian Cohort
A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. 95% CI was based on the Clopper and Pearson method.
Time frame: From Dose 1 to 1 month after Dose 3
Population: Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 20vPnC: Primary Study Population | Percentage of Participants With NDCMC From Dose 1 to 1 Month After Dose 3: Russian Cohort | 0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With NDCMC From Dose 1 to 1 Month After Dose 3: Russian Cohort | 0 Percentage of participants |
Primary
Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From Dose 1 to 1 Month After Dose 3: Primary Study Population
A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. 95% CI was based on the Clopper and Pearson method.
Time frame: From Dose 1 to 1 month after Dose 3
Population: Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| 20vPnC: Primary Study Population | Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From Dose 1 to 1 Month After Dose 3: Primary Study Population | 1.0 Percentage of participants | 95% Confidence Interval 0.4 |
| 13vPnC: Primary Study Population | Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From Dose 1 to 1 Month After Dose 3: Primary Study Population | 1.0 Percentage of participants | 95% Confidence Interval 0.4 |
Primary
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population
Diphtheria and tetanus toxoids: concentration of antibody (AB) (in international units \[IU\]) to diphtheria & tetanus toxoid (prespecified level\>=0.1 IU/mL); Pertussis antigens-pertussis toxin (PT), filamentous hemagglutinin (FHA), pertactin (PRN): prespecified level \>=observed Anti pertussis Antibody concentration achieved by 95% of 13vPnC recipient; HBsAg prespecified level \>=10 milli-IU per mL (mIU/mL); Poliovirus strains (types 1, 2 and 3): prespecified level: \>=1:8; Hemophilus influenzae type b(Hib): prespecified level \>=0.15 microgram per millilitre (mcg/mL) polyribosylribitol phosphate (anti-PRP) in mcg/mL. Concomitant vaccine response was assessed from subset of randomly selected study participants.
Time frame: 1 month after Dose 3
Population: Dose 3 EIP = eligible participants 42-112 days of age at first vaccination, received all 3 doses as randomized with 335-386 days of age at Dose 3, at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, no major protocol deviations. Number of Participants Analyzed= participants in Dose 3 EIP and Number Analyzed= participants with valid assay results for specified concomitant vaccine antigen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population | Diphtheria toxoid | 99.6 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population | Tetanus toxoid | 99.4 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population | Pertussis: PT | 92.9 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population | Pertussis: FHA | 95.3 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population | Pertussis: PRN | 96.8 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population | Hepatitis B | 100.0 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population | Poliovirus: Type 1 | 100.0 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population | Poliovirus: Type 2 | 100.0 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population | Poliovirus: Type 3 | 100.0 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population | Hemophilus influenzae type b | 100.0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population | Poliovirus: Type 2 | 100.0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population | Diphtheria toxoid | 99.8 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population | Hepatitis B | 98.9 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population | Tetanus toxoid | 100.0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population | Hemophilus influenzae type b | 100.0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population | Pertussis: PT | 95.2 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population | Poliovirus: Type 1 | 100.0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population | Pertussis: FHA | 95.2 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population | Poliovirus: Type 3 | 100.0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 3: Primary Study Population | Pertussis: PRN | 95.2 Percentage of participants |
Comparison: Diphtheria95% CI: [-1.3, 0.8]
Comparison: Tetanus95% CI: [-1.8, 0.2]
Comparison: PT95% CI: [-5.3, 0.7]
Comparison: FHA95% CI: [-2.6, 2.9]
Comparison: PRN95% CI: [-0.9, 4.2]
Comparison: Hepatitis B95% CI: [-1.1, 4]
Comparison: Poliovirus Type 195% CI: [-4.6, 4.2]
Comparison: Poliovirus Type 295% CI: [-4.6, 4.2]
Comparison: Poliovirus Type 395% CI: [-4.6, 4.2]
Comparison: Hib95% CI: [-2, 2.2]
Primary
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort
Predefined IgG concentrations were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: \>=0.35 mcg/mL, for serotype 5: \>=0.23 mcg/mL, for serotype 6B. \>=0.10 mcg/mL and for serotype 19A: \>=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method.
Time frame: 1 month after Dose 2
Population: Dose 2 evaluable immunogenicity population: eligible participants 42-70 days of age at first vaccination, received first 2 doses as randomized, at least 1 valid immunogenicity results within 27 to 56 days after Dose 2, no other major protocol deviations. Number of Participants Analyzed= participants in Dose 2 evaluable immunogenicity population; Number Analyzed= participants with valid IgG results for specified serotype.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 4 | 75.0 Percentage of participants | 95% Confidence Interval 53.3 |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 19A | 87.5 Percentage of participants | 95% Confidence Interval 67.6 |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 6B | 20.8 Percentage of participants | 95% Confidence Interval 7.1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 19F | 79.2 Percentage of participants | 95% Confidence Interval 57.8 |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 3 | 37.5 Percentage of participants | 95% Confidence Interval 18.8 |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 23F | 37.5 Percentage of participants | 95% Confidence Interval 18.8 |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 7F | 95.8 Percentage of participants | 95% Confidence Interval 78.9 |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 8 | 75.0 Percentage of participants | 95% Confidence Interval 53.3 |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 5 | 66.7 Percentage of participants | 95% Confidence Interval 44.7 |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 10A | 41.7 Percentage of participants | 95% Confidence Interval 22.1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 9V | 41.7 Percentage of participants | 95% Confidence Interval 22.1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 1 | 70.8 Percentage of participants | 95% Confidence Interval 48.9 |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 12F | 12.5 Percentage of participants | 95% Confidence Interval 2.7 |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 14 | 83.3 Percentage of participants | 95% Confidence Interval 62.6 |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 15B | 66.7 Percentage of participants | 95% Confidence Interval 44.7 |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 6A | 54.2 Percentage of participants | 95% Confidence Interval 32.8 |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 22F | 66.7 Percentage of participants | 95% Confidence Interval 44.7 |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 18C | 66.7 Percentage of participants | 95% Confidence Interval 44.7 |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 33F | 45.8 Percentage of participants | 95% Confidence Interval 25.6 |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 11A | 83.3 Percentage of participants | 95% Confidence Interval 62.6 |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 33F | 25.9 Percentage of participants | 95% Confidence Interval 11.1 |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 1 | 77.8 Percentage of participants | 95% Confidence Interval 57.7 |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 3 | 59.3 Percentage of participants | 95% Confidence Interval 38.8 |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 4 | 74.1 Percentage of participants | 95% Confidence Interval 53.7 |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 5 | 81.5 Percentage of participants | 95% Confidence Interval 61.9 |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 6A | 81.5 Percentage of participants | 95% Confidence Interval 61.9 |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 6B | 59.3 Percentage of participants | 95% Confidence Interval 38.8 |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 7F | 92.6 Percentage of participants | 95% Confidence Interval 75.7 |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 9V | 81.5 Percentage of participants | 95% Confidence Interval 61.9 |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 14 | 85.2 Percentage of participants | 95% Confidence Interval 66.3 |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 18C | 81.5 Percentage of participants | 95% Confidence Interval 61.9 |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 19A | 92.6 Percentage of participants | 95% Confidence Interval 75.7 |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 19F | 96.3 Percentage of participants | 95% Confidence Interval 81 |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 23F | 70.4 Percentage of participants | 95% Confidence Interval 49.8 |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 8 | 33.3 Percentage of participants | 95% Confidence Interval 16.5 |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 10A | 18.5 Percentage of participants | 95% Confidence Interval 6.3 |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 11A | 18.5 Percentage of participants | 95% Confidence Interval 6.3 |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 12F | 14.8 Percentage of participants | 95% Confidence Interval 4.2 |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 15B | 33.3 Percentage of participants | 95% Confidence Interval 16.5 |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 2: Russian Cohort | Serotype 22F | 14.8 Percentage of participants | 95% Confidence Interval 4.2 |
Primary
Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population
Predefined IgG concentrations were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: \>=0.35 microgram per mL (mcg/mL), for serotype 5: \>=0.23 mcg/mL, for serotype 6B: \>=0.10 mcg/mL and for serotype 19A: \>=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method.
Time frame: 1 month after Dose 2
Population: Dose 2 evaluable immunogenicity population: eligible participants 42-112 days of age at first vaccination, received first 2 doses as randomized, at least 1 valid immunogenicity results from blood collection (27 to 56 days after Dose 2), no other major protocol deviations. Number of Participants Analyzed= participants in Dose 2 evaluable immunogenicity population, Number Analyzed= participants with valid IgG assay results for specified serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 4 | 68.6 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 19A | 92.2 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 6B | 20.7 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 19F | 94.3 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 3 | 58.0 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 23F | 23.5 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 7F | 87.6 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 8 | 96.5 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 5 | 63.4 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 10A | 28.9 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 9V | 60.2 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 11A | 94.2 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 1 | 70.7 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 12F | 30.3 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 14 | 78.6 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 15B | 94.3 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 6A | 59.5 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 18C | 71.0 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 33F | 46.8 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 22F | 94.4 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 33F | 2.7 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 1 | 84.2 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 3 | 75.8 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 4 | 79.5 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 5 | 76.0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 6A | 73.7 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 6B | 36.5 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 7F | 90.2 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 9V | 74.6 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 14 | 81.9 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 18C | 76.5 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 19A | 94.0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 19F | 95.7 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 23F | 41.8 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 8 | 2.9 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 10A | 2.7 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 11A | 2.0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 12F | 0.2 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 15B | 8.5 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2: Primary Study Population | Serotype 22F | 2.0 Percentage of participants |
Comparison: Serotype 195% CI: [-18.3, -8.7]
Comparison: Serotype 395% CI: [-23.2, -12.4]
Comparison: Serotype 495% CI: [-16, -5.9]
Comparison: Serotype 595% CI: [-17.8, -7.2]
Comparison: Serotype 6A95% CI: [-19.5, -8.6]
Comparison: Serotype 6B95% CI: [-21, -10.6]
Comparison: Serotype 7F95% CI: [-6.3, 1.1]
Comparison: Serotype 9V95% CI: [-19.7, -8.9]
Comparison: Serotype 1495% CI: [-7.9, 1.4]
Comparison: Serotype 18C95% CI: [-10.6, -0.4]
Comparison: Serotype 19A95% CI: [-4.8, 1.3]
Comparison: Serotype 19F95% CI: [-4, 1.2]
Comparison: Serotype 23F95% CI: [-23.6, -12.9]
Comparison: Serotype 895% CI: [55.6, 64.1]
Comparison: Serotype 10A95% CI: [-13.1, -2.1]
Comparison: Serotype 11A95% CI: [53.1, 61.9]
Comparison: Serotype 12F95% CI: [-11.7, -0.7]
Comparison: Serotype 15B95% CI: [53.3, 62.1]
Comparison: Serotype 22F95% CI: [53.3, 62.1]
Comparison: Serotype 33F95% CI: [4.5, 16]
Primary
Percentage of Participants With SAEs From Dose 1 to 1 Month After Dose 3: Russian Cohort
A SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method.
Time frame: From Dose 1 to 1 month after Dose 3
Population: Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 20vPnC: Primary Study Population | Percentage of Participants With SAEs From Dose 1 to 1 Month After Dose 3: Russian Cohort | 0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With SAEs From Dose 1 to 1 Month After Dose 3: Russian Cohort | 0 Percentage of participants |
Primary
Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 3: Primary Study Population
A SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method.
Time frame: From Dose 1 to 1 month after Dose 3
Population: Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| 20vPnC: Primary Study Population | Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 3: Primary Study Population | 5.7 Percentage of participants | 95% Confidence Interval 3.9 |
| 13vPnC: Primary Study Population | Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 3: Primary Study Population | 6.6 Percentage of participants | 95% Confidence Interval 4.8 |
Primary
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population
Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: was defined as temperature \>=38.0 degree Celsius (C) and categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.
Time frame: Within 7 Days after Dose 1
Population: Safety analysis set: all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose. Here, Number of Participants Analyzed signifies number of participants with any e-diary data after Dose 1.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population | Fever: >38.9 degrees C to 40.0 degrees C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population | Drowsiness: Mild | 46.0 Percentage of participants | 95% Confidence Interval 41.9 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population | Decreased appetite: Mild | 16.2 Percentage of participants | 95% Confidence Interval 13.4 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population | Drowsiness: Moderate | 14.4 Percentage of participants | 95% Confidence Interval 11.7 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population | Fever: >38.4 degrees C to 38.9 degrees C | 1.3 Percentage of participants | 95% Confidence Interval 0.6 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population | Drowsiness: Severe | 0.8 Percentage of participants | 95% Confidence Interval 0.3 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population | Decreased appetite: Moderate | 7.5 Percentage of participants | 95% Confidence Interval 5.5 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population | Irritability: Mild | 17.6 Percentage of participants | 95% Confidence Interval 14.6 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population | Fever: >40.0 degrees C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population | Irritability: Moderate | 46.2 Percentage of participants | 95% Confidence Interval 42.1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population | Decreased appetite: Severe | 1.0 Percentage of participants | 95% Confidence Interval 0.4 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population | Irritability: Severe | 8.2 Percentage of participants | 95% Confidence Interval 6.1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population | Fever: >=38.0 degrees C to 38.4 degrees C | 7.5 Percentage of participants | 95% Confidence Interval 5.5 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population | Irritability: Severe | 8.6 Percentage of participants | 95% Confidence Interval 6.5 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population | Fever: >=38.0 degrees C to 38.4 degrees C | 6.8 Percentage of participants | 95% Confidence Interval 4.9 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population | Fever: >38.4 degrees C to 38.9 degrees C | 1.3 Percentage of participants | 95% Confidence Interval 0.6 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population | Fever: >38.9 degrees C to 40.0 degrees C | 0.3 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population | Fever: >40.0 degrees C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population | Decreased appetite: Mild | 13.3 Percentage of participants | 95% Confidence Interval 10.7 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population | Decreased appetite: Moderate | 8.8 Percentage of participants | 95% Confidence Interval 6.7 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population | Decreased appetite: Severe | 0.5 Percentage of participants | 95% Confidence Interval 0.1 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population | Drowsiness: Mild | 48.6 Percentage of participants | 95% Confidence Interval 44.5 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population | Drowsiness: Moderate | 14.3 Percentage of participants | 95% Confidence Interval 11.6 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population | Drowsiness: Severe | 0.8 Percentage of participants | 95% Confidence Interval 0.3 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population | Irritability: Mild | 17.4 Percentage of participants | 95% Confidence Interval 14.5 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Primary Study Population | Irritability: Moderate | 46.4 Percentage of participants | 95% Confidence Interval 42.4 |
Primary
Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort
Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using e-diary. Fever: temperature \>=38.0 degree C & categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0-degree C. Decreased appetite: was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper & Pearson method.
Time frame: Within 7 Days after Dose 1
Population: Safety analysis set: all participants who received at least 1 dose of 20vPnC or 13vPnC \& had safety data assessed after any dose. Here, Number of Participants Analyzed signifies number of participants with any e-diary data after Dose 1.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort | Fever: >38.9 degrees C to 40.0 degrees C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort | Drowsiness: Mild | 20.8 Percentage of participants | 95% Confidence Interval 7.1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort | Decreased appetite: Mild | 16.7 Percentage of participants | 95% Confidence Interval 4.7 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort | Drowsiness: Moderate | 8.3 Percentage of participants | 95% Confidence Interval 1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort | Fever: >38.4 degrees C to 38.9 degrees C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort | Drowsiness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort | Decreased appetite: Moderate | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort | Irritability: Mild | 12.5 Percentage of participants | 95% Confidence Interval 2.7 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort | Fever: >40.0 degrees C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort | Irritability: Moderate | 8.3 Percentage of participants | 95% Confidence Interval 1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort | Decreased appetite: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort | Irritability: Severe | 4.2 Percentage of participants | 95% Confidence Interval 0.1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort | Fever: >=38.0 degrees C to 38.4 degrees C | 4.2 Percentage of participants | 95% Confidence Interval 0.1 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort | Irritability: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort | Fever: >=38.0 degrees C to 38.4 degrees C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort | Fever: >38.4 degrees C to 38.9 degrees C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort | Fever: >38.9 degrees C to 40.0 degrees C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort | Fever: >40.0 degrees C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort | Decreased appetite: Mild | 14.8 Percentage of participants | 95% Confidence Interval 4.2 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort | Decreased appetite: Moderate | 3.7 Percentage of participants | 95% Confidence Interval 0.1 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort | Decreased appetite: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort | Drowsiness: Mild | 18.5 Percentage of participants | 95% Confidence Interval 6.3 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort | Drowsiness: Moderate | 11.1 Percentage of participants | 95% Confidence Interval 2.4 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort | Drowsiness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort | Irritability: Mild | 7.4 Percentage of participants | 95% Confidence Interval 0.9 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Russian Cohort | Irritability: Moderate | 14.8 Percentage of participants | 95% Confidence Interval 4.2 |
Primary
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population
Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participant's using an e-diary. Fever: was defined as temperature \>=38.0 degree C and categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.
Time frame: Within 7 Days after Dose 2
Population: Safety analysis set: all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose. Here, Number of Participants Analyzed signifies number of participants with any e-diary data after Dose 2.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population | Fever: >38.9 degrees C to 40.0 degrees C | 0.7 Percentage of participants | 95% Confidence Interval 0.2 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population | Drowsiness: Mild | 37.8 Percentage of participants | 95% Confidence Interval 33.9 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population | Decreased appetite: Mild | 13.5 Percentage of participants | 95% Confidence Interval 10.9 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population | Drowsiness: Moderate | 13.2 Percentage of participants | 95% Confidence Interval 10.6 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population | Fever: >38.4 degrees C to 38.9 degrees C | 2.5 Percentage of participants | 95% Confidence Interval 1.4 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population | Drowsiness: Severe | 0.3 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population | Decreased appetite: Moderate | 10.1 Percentage of participants | 95% Confidence Interval 7.8 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population | Irritability: Mild | 22.8 Percentage of participants | 95% Confidence Interval 19.5 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population | Fever: >40.0 degrees C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population | Irritability: Moderate | 43.1 Percentage of participants | 95% Confidence Interval 39 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population | Decreased appetite: Severe | 1.0 Percentage of participants | 95% Confidence Interval 0.4 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population | Irritability: Severe | 5.7 Percentage of participants | 95% Confidence Interval 4 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population | Fever: >=38.0 degrees C to 38.4 degrees C | 11.7 Percentage of participants | 95% Confidence Interval 9.2 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population | Irritability: Severe | 6.6 Percentage of participants | 95% Confidence Interval 4.7 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population | Fever: >=38.0 degrees C to 38.4 degrees C | 11.6 Percentage of participants | 95% Confidence Interval 9.2 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population | Fever: >38.4 degrees C to 38.9 degrees C | 2.0 Percentage of participants | 95% Confidence Interval 1 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population | Fever: >38.9 degrees C to 40.0 degrees C | 0.3 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population | Fever: >40.0 degrees C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population | Decreased appetite: Mild | 12.1 Percentage of participants | 95% Confidence Interval 9.6 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population | Decreased appetite: Moderate | 6.4 Percentage of participants | 95% Confidence Interval 4.6 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population | Decreased appetite: Severe | 0.8 Percentage of participants | 95% Confidence Interval 0.3 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population | Drowsiness: Mild | 37.0 Percentage of participants | 95% Confidence Interval 33.1 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population | Drowsiness: Moderate | 13.5 Percentage of participants | 95% Confidence Interval 10.8 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population | Drowsiness: Severe | 0.2 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population | Irritability: Mild | 21.2 Percentage of participants | 95% Confidence Interval 18 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Primary Study Population | Irritability: Moderate | 40.6 Percentage of participants | 95% Confidence Interval 36.6 |
Primary
Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort
Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: temperature \>=38.0 degree C and categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper & Pearson method.
Time frame: Within 7 Days after Dose 2
Population: Safety analysis set: all participants who received at least 1 dose of 20vPnC or 13vPnC \& had safety data assessed after any dose. Here, Number of Participants Analyzed: number of participants with any e-diary data after Dose 2
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort | Fever: >38.9 degrees C to 40.0 degrees C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort | Drowsiness: Mild | 4.3 Percentage of participants | 95% Confidence Interval 0.1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort | Decreased appetite: Mild | 4.3 Percentage of participants | 95% Confidence Interval 0.1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort | Drowsiness: Moderate | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort | Fever: >38.4 degrees C to 38.9 degrees C | 4.3 Percentage of participants | 95% Confidence Interval 0.1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort | Drowsiness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort | Decreased appetite: Moderate | 4.3 Percentage of participants | 95% Confidence Interval 0.1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort | Irritability: Mild | 13.0 Percentage of participants | 95% Confidence Interval 2.8 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort | Fever: >40.0 degrees C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort | Irritability: Moderate | 4.3 Percentage of participants | 95% Confidence Interval 0.1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort | Decreased appetite: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort | Irritability: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort | Fever: >=38.0 degrees C to 38.4 degrees C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort | Irritability: Severe | 3.7 Percentage of participants | 95% Confidence Interval 0.1 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort | Fever: >=38.0 degrees C to 38.4 degrees C | 11.1 Percentage of participants | 95% Confidence Interval 2.4 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort | Fever: >38.4 degrees C to 38.9 degrees C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort | Fever: >38.9 degrees C to 40.0 degrees C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort | Fever: >40.0 degrees C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort | Decreased appetite: Mild | 7.4 Percentage of participants | 95% Confidence Interval 0.9 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort | Decreased appetite: Moderate | 3.7 Percentage of participants | 95% Confidence Interval 0.1 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort | Decreased appetite: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort | Drowsiness: Mild | 3.7 Percentage of participants | 95% Confidence Interval 0.1 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort | Drowsiness: Moderate | 3.7 Percentage of participants | 95% Confidence Interval 0.1 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort | Drowsiness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort | Irritability: Mild | 22.2 Percentage of participants | 95% Confidence Interval 8.6 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Russian Cohort | Irritability: Moderate | 18.5 Percentage of participants | 95% Confidence Interval 6.3 |
Primary
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population
Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: was defined as temperature \>=38.0 degree C and categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) & severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper and Pearson method.
Time frame: Within 7 Days after Dose 3
Population: Safety analysis set: all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose. Here, Number of Participants Analyzed signifies number of participants with any e-diary data after Dose 3.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population | Fever: >38.9 degrees C to 40.0 degrees C | 3.6 Percentage of participants | 95% Confidence Interval 2.3 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population | Drowsiness: Mild | 34.8 Percentage of participants | 95% Confidence Interval 30.9 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population | Decreased appetite: Mild | 20.0 Percentage of participants | 95% Confidence Interval 16.8 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population | Drowsiness: Moderate | 15.3 Percentage of participants | 95% Confidence Interval 12.5 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population | Fever: >38.4 degrees C to 38.9 degrees C | 6.9 Percentage of participants | 95% Confidence Interval 5 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population | Drowsiness: Severe | 0.7 Percentage of participants | 95% Confidence Interval 0.2 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population | Decreased appetite: Moderate | 17.1 Percentage of participants | 95% Confidence Interval 14.1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population | Irritability: Mild | 23.4 Percentage of participants | 95% Confidence Interval 20.1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population | Fever: >40.0 degrees C | 0.3 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population | Irritability: Moderate | 43.4 Percentage of participants | 95% Confidence Interval 39.4 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population | Decreased appetite: Severe | 2.2 Percentage of participants | 95% Confidence Interval 1.2 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population | Irritability: Severe | 4.1 Percentage of participants | 95% Confidence Interval 2.7 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population | Fever: >=38.0 degrees C to 38.4 degrees C | 13.4 Percentage of participants | 95% Confidence Interval 10.8 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population | Irritability: Severe | 4.1 Percentage of participants | 95% Confidence Interval 2.6 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population | Fever: >=38.0 degrees C to 38.4 degrees C | 13.5 Percentage of participants | 95% Confidence Interval 10.8 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population | Fever: >38.4 degrees C to 38.9 degrees C | 7.0 Percentage of participants | 95% Confidence Interval 5.1 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population | Fever: >38.9 degrees C to 40.0 degrees C | 3.2 Percentage of participants | 95% Confidence Interval 2 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population | Fever: >40.0 degrees C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population | Decreased appetite: Mild | 15.5 Percentage of participants | 95% Confidence Interval 12.7 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population | Decreased appetite: Moderate | 18.9 Percentage of participants | 95% Confidence Interval 15.8 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population | Decreased appetite: Severe | 2.0 Percentage of participants | 95% Confidence Interval 1.1 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population | Drowsiness: Mild | 32.8 Percentage of participants | 95% Confidence Interval 29 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population | Drowsiness: Moderate | 14.7 Percentage of participants | 95% Confidence Interval 11.9 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population | Drowsiness: Severe | 1.2 Percentage of participants | 95% Confidence Interval 0.5 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population | Irritability: Mild | 21.3 Percentage of participants | 95% Confidence Interval 18.1 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Primary Study Population | Irritability: Moderate | 45.4 Percentage of participants | 95% Confidence Interval 41.3 |
Primary
Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort
Systemic events: fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: temperature \>=38.0 degree C and categorized as \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0-degree C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased/prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability: mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). 95% CI was based on Clopper & Pearson method.
Time frame: Within 7 Days after Dose 3
Population: Safety analysis set: all participants who received at least 1 dose of 20vPnC or 13vPnC \& had safety data assessed after any dose. Here, Number of Participants Analyzed: number of participants with any e-diary data after Dose 3.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort | Fever: >38.9 degrees C to 40.0 degrees C | 4.5 Percentage of participants | 95% Confidence Interval 0.1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort | Drowsiness: Mild | 13.6 Percentage of participants | 95% Confidence Interval 2.9 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort | Decreased appetite: Mild | 9.1 Percentage of participants | 95% Confidence Interval 1.1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort | Drowsiness: Moderate | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort | Fever: >38.4 degrees C to 38.9 degrees C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort | Drowsiness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort | Decreased appetite: Moderate | 9.1 Percentage of participants | 95% Confidence Interval 1.1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort | Irritability: Mild | 27.3 Percentage of participants | 95% Confidence Interval 10.7 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort | Fever: >40.0 degrees C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort | Irritability: Moderate | 9.1 Percentage of participants | 95% Confidence Interval 1.1 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort | Decreased appetite: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort | Irritability: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 20vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort | Fever: >=38.0 degrees C to 38.4 degrees C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort | Irritability: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort | Fever: >=38.0 degrees C to 38.4 degrees C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort | Fever: >38.4 degrees C to 38.9 degrees C | 4.0 Percentage of participants | 95% Confidence Interval 0.1 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort | Fever: >38.9 degrees C to 40.0 degrees C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort | Fever: >40.0 degrees C | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort | Decreased appetite: Mild | 8.0 Percentage of participants | 95% Confidence Interval 1 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort | Decreased appetite: Moderate | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort | Decreased appetite: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort | Drowsiness: Mild | 20.0 Percentage of participants | 95% Confidence Interval 6.8 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort | Drowsiness: Moderate | 4.0 Percentage of participants | 95% Confidence Interval 0.1 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort | Drowsiness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort | Irritability: Mild | 16.0 Percentage of participants | 95% Confidence Interval 4.5 |
| 13vPnC: Primary Study Population | Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Russian Cohort | Irritability: Moderate | 8.0 Percentage of participants | 95% Confidence Interval 1 |
Secondary
Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population
20vPnC serotypes included: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Assay results below the LLOQ were set to 0.5\*LLOQ in the analysis. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs (based on the Student's t distribution).
Time frame: Before Dose 3 to 1 month after Dose 3
Population: Dose 3 evaluable immunogenicity population = eligible participants 42-112 days of age at first vaccination, received all 3 doses as randomized with 335-386 days of age at Dose 3, at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, no major protocol deviations. Number of Participants Analyzed= participants in Dose 3 evaluable immunogenicity population; Number Analysed= participants in Dose 3 EIP at both timepoints.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 20vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 4 | 29.8 Fold rise |
| 20vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 19A | 39.3 Fold rise |
| 20vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 6B | 36.8 Fold rise |
| 20vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 19F | 20.5 Fold rise |
| 20vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 3 | 13.7 Fold rise |
| 20vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 23F | 32.3 Fold rise |
| 20vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 7F | 8.5 Fold rise |
| 20vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 8 | 12.7 Fold rise |
| 20vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 5 | 14.0 Fold rise |
| 20vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 10A | 14.8 Fold rise |
| 20vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 9V | 22.5 Fold rise |
| 20vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 11A | 13.8 Fold rise |
| 20vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 1 | 13.9 Fold rise |
| 20vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 14 | 9.7 Fold rise |
| 20vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 15B | 13.4 Fold rise |
| 20vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 6A | 26.9 Fold rise |
| 20vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 22F | 12.8 Fold rise |
| 20vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 18C | 15.8 Fold rise |
| 20vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 33F | 12.9 Fold rise |
| 20vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 12F | 16.5 Fold rise |
| 13vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 33F | 1.1 Fold rise |
| 13vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 1 | 13.9 Fold rise |
| 13vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 3 | 15.2 Fold rise |
| 13vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 4 | 27.7 Fold rise |
| 13vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 5 | 13.6 Fold rise |
| 13vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 6A | 28.7 Fold rise |
| 13vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 6B | 40.2 Fold rise |
| 13vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 7F | 9.3 Fold rise |
| 13vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 9V | 19.9 Fold rise |
| 13vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 14 | 8.4 Fold rise |
| 13vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 18C | 17.0 Fold rise |
| 13vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 19A | 40.7 Fold rise |
| 13vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 19F | 21.4 Fold rise |
| 13vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 23F | 38.3 Fold rise |
| 13vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 8 | 1.4 Fold rise |
| 13vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 10A | 1.1 Fold rise |
| 13vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 11A | 1.1 Fold rise |
| 13vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 12F | 1.0 Fold rise |
| 13vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 15B | 1.3 Fold rise |
| 13vPnC: Primary Study Population | Geometric Mean Fold Rise (GMFRs) of IgG Concentrations From Before Dose 3 to 1 Month After Dose 3: Primary Study Population | Serotype 22F | 1.3 Fold rise |
Secondary
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population
OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomly selected subsets of participants at 1 month after Dose 2. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the Student's t distribution.
Time frame: 1 month after Dose 2
Population: Dose 2 evaluable immunogenicity population: eligible participants 42-112 days of age at first vaccination, received first 2 doses as randomized, at least 1 valid immunogenicity results within 27 to 56 days after Dose 2, no other major protocol deviations. Number of Participants Analyzed= participants in Dose 2 evaluable immunogenicity population, Number Analyzed= participants with valid OPA assay results for specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 1 | 14 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 3 | 31 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 4 | 333 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 5 | 21 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 6A | 347 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 6B | 54 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 7F | 858 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 9V | 233 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 14 | 287 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 18C | 588 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 19A | 57 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 19F | 97 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 23F | 59 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 8 | 164 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 10A | 855 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 11A | 327 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 12F | 4788 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 15B | 846 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 22F | 4444 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 33F | 2373 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 15B | 17 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 1 | 23 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 19A | 91 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 3 | 40 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 11A | 49 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 4 | 391 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 19F | 117 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 5 | 27 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 33F | 178 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 6A | 409 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 23F | 68 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 6B | 105 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 12F | 26 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 7F | 895 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 8 | 17 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 9V | 285 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 22F | 10 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 14 | 360 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 10A | 39 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 2: Primary Study Population | Serotype 18C | 719 Titers |
Secondary
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population
OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomly selected subsets of participants at 1 month after Dose 3. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the Student's t distribution.
Time frame: 1 Month after Dose 3
Population: Dose 3 evaluable immunogenicity population = eligible participants 42-112 days of age at first vaccination, received all 3 doses as randomized with 335-386 days of age at Dose 3, at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, no major protocol deviations. Number of Participants Analyzed= participants in Dose 3 evaluable immunogenicity population; Number Analyzed= participants with valid assay results for specified OPA serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 1 | 54 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 3 | 99 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 4 | 904 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 5 | 60 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 6A | 1101 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 6B | 537 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 7F | 1811 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 9V | 3254 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 14 | 738 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 18C | 1296 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 19A | 754 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 19F | 183 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 23F | 697 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 8 | 1398 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 10A | 3403 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 11A | 2966 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 12F | 5501 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 15B | 2676 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 22F | 6523 Titers |
| 20vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 33F | 11315 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 15B | 23 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 1 | 101 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 19A | 707 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 3 | 129 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 11A | 66 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 4 | 992 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 19F | 258 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 5 | 82 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 33F | 708 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 6A | 1304 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 23F | 975 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 6B | 864 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 12F | 29 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 7F | 2197 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 8 | 31 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 9V | 4544 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 22F | 17 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 14 | 926 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 10A | 69 Titers |
| 13vPnC: Primary Study Population | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) 1 Month After Dose 3: Primary Study Population | Serotype 18C | 1870 Titers |
Secondary
GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort
OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomly selected subsets of participants at 1 month after Dose 2. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the student's t distribution.
Time frame: 1 month after Dose 2
Population: Dose 2 evaluable immunogenicity population: eligible participants 42-70 days of age at first vaccination, received first 2 doses as randomized, at least 1 valid immunogenicity results from blood collection (27 to 56 days after Dose 2), no other major protocol deviations. Number of participants Analyzed= participants in Dose 2 evaluable immunogenicity population, Number Analyzed= participants with valid OPA assay results for specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 3 | 79 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 18C | 968 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 6A | 222 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 19A | 314 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 1 | 17 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 19F | 120 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 6B | 314 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 23F | 35 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 4 | 166 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 7F | 809 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 11A | 3537 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 10A | 559 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 12F | 698 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 9V | 218 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 15B | 142 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 5 | 28 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 22F | 413 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 14 | 984 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 33F | 3508 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 8 | 203 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 33F | 3961 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 8 | 38 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 1 | 33 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 3 | 31 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 4 | 163 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 5 | 31 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 6A | 247 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 6B | 216 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 7F | 717 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 9V | 293 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 14 | 247 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 18C | 268 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 19A | 31 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 19F | 230 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 23F | 56 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 10A | 232 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 11A | 2717 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 12F | 198 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 15B | 242 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 2: Russian Cohort | Serotype 22F | 499 Titers |
Secondary
GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort
OPA titers for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined in randomly selected subsets of participants at 1 month after Dose 3. Results were expressed as OPA titers. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the student's t distribution.
Time frame: 1 Month after Dose 3
Population: Dose 3 evaluable immunogenicity population = eligible participants 42-70 days of age at first vaccination, received all 3 doses as randomized with 335-455 days of age at Dose 3, at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, no major protocol deviations. Number of participants Analyzed= participants in Dose 3 evaluable immunogenicity population; Number Analyzed= participants with valid OPA assay results for specified serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 4 | 310 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 19A | 652 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 6B | 4417 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 19F | 1570 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 3 | 126 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 23F | 152 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 7F | 1039 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 8 | 368 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 5 | 116 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 10A | 2851 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 9V | 1574 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 11A | 7137 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 1 | 85 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 12F | 757 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 15B | 822 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 14 | 1151 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 22F | 1983 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 6A | 2922 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 33F | 5903 Titers |
| 20vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 18C | 583 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 33F | 3619 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 1 | 93 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 3 | 107 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 4 | 429 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 5 | 108 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 6A | 1580 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 6B | 1397 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 7F | 1411 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 9V | 1067 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 14 | 628 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 18C | 973 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 19A | 435 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 19F | 701 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 23F | 410 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 8 | 149 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 10A | 117 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 11A | 1789 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 15B | 147 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 22F | 1635 Titers |
| 13vPnC: Primary Study Population | GMTs of Serotype-specific OPA at 1 Month After Dose 3: Russian Cohort | Serotype 12F | 241 Titers |
Secondary
Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population
Pre-specified vaccines were administered concomitantly with 20vPnC or 13vPnC and responses assessed using pre-defined levels as follows: Diphtheria and tetanus toxoids: concentration of antibody (in international units \[IU\]) to diphtheria and tetanus toxoid (prespecified level \>= observed anti-pertussis antibody concentration achieved by 95% of 13vPnC recipients); Poliomyelitis: NA titers to poliovirus types 1, 2, and 3 (prespecified level NA titer \>=1:8); and Hib: concentration of antibody to Hib (PRP) in mcg/mL (prespecified level \>=0.15 mcg/mL anti-PRP). 2-sided 95% CI was based on Clopper and Pearson method. The assays were performed on randomly selected subsets.
Time frame: 1 month after Dose 2
Population: Dose 2 EIP=eligible participants 42-112 days of age at first vaccine, received 2 dose as randomized, at least 1 valid immunogenicity result from blood collection (27 to 56 days after Dose 2), no other major protocol deviations. Number of Participants Analyzed= participants in Dose 2 evaluable immunogenicity population; Number Analyzed= participants with valid assay results for specified concomitant vaccine antigen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population | Tetanus toxoid | 95.5 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population | Poliovirus: Type 1 | 94.8 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population | Pertussis: FHA | 93.5 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population | Poliovirus: Type 2 | 88.5 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population | Pertussis: PT | 94.5 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population | Poliovirus: Type 3 | 95.8 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population | Pertussis: PRN | 93.5 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population | Hemophilus influenzae type b | 100.0 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population | Diphtheria toxoid | 85.0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population | Hemophilus influenzae type b | 100.0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population | Diphtheria toxoid | 89.5 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population | Tetanus toxoid | 98.5 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population | Pertussis: PT | 95.0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population | Pertussis: FHA | 95.0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population | Pertussis: PRN | 95.0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population | Poliovirus: Type 1 | 98.1 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population | Poliovirus: Type 2 | 91.3 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Antibody Levels for Concomitant Vaccine Antigens 1 Month After Dose 2: Primary Study Population | Poliovirus: Type 3 | 100.0 Percentage of participants |
Comparison: Diphtheria95% CI: [-11.2, 2.1]
Comparison: Tetanus95% CI: [-7, 0.4]
Comparison: PT95% CI: [-5.2, 4.1]
Comparison: FHA95% CI: [-6.4, 3.3]
Comparison: PRN95% CI: [-6.4, 3.3]
Comparison: Poliovirus Type 195% CI: [-10, 2.2]
Comparison: Poliovirus Type 295% CI: [-11.8, 5.8]
Comparison: Poliovirus Type 395% CI: [-10.2, -0.5]
Comparison: Hib95% CI: [-1.8, 2]
Secondary
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population
Predefined IgG concentrations were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: \>=0.35 mcg/mL, for serotype 5: \>=0.23 mcg/mL, for serotype 6B: \>=0.10 mcg/mL and for serotype 19A: \>=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method.
Time frame: 1 Month after Dose 3
Population: Dose 3 evaluable immunogenicity population = eligible participants 42-112 days of age at first vaccination, received all 3 doses as randomized with 335-386 days of age at Dose 3, at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, no major protocol deviations. Number of Participants Analyzed= participants in Dose 3 evaluable immunogenicity population; Number Analyzed= participants with valid IgG results for specified serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 1 | 97.2 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 3 | 82.6 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 4 | 99.2 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 5 | 98.4 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 6A | 98.8 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 6B | 98.4 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 7F | 99.6 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 9V | 99.2 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 14 | 96.6 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 18C | 99.2 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 19A | 99.6 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 19F | 99.6 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 23F | 96.4 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 8 | 99.2 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 10A | 97.8 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 11A | 98.4 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 12F | 96.6 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 15B | 99.4 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 22F | 99.2 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 33F | 98.6 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 15B | 4.8 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 1 | 98.2 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 19A | 99.6 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 3 | 93.2 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 11A | 4.6 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 4 | 99.2 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 19F | 99.4 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 5 | 98.0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 33F | 1.8 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 6A | 98.8 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 23F | 97.2 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 6B | 97.6 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 12F | 0.2 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 7F | 100.0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 8 | 3.6 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 9V | 98.8 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 22F | 1.4 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 14 | 98.0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 10A | 1.6 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Primary Study Population | Serotype 18C | 98.2 Percentage of participants |
Comparison: Serotype 1 \\95% CI: [-3.1, 0.9]
Comparison: Serotype 395% CI: [-14.7, -6.7]
Comparison: Serotype 495% CI: [-1.4, 1.3]
Comparison: Serotype 595% CI: [-1.4, 2.2]
Comparison: Serotype 6A95% CI: [-1.6, 1.5]
Comparison: Serotype 6B95% CI: [-1.1, 2.7]
Comparison: Serotype 7F95% CI: [-1.5, 0.4]
Comparison: Serotype 9V95% CI: [-1, 1.9]
Comparison: Serotype 1495% CI: [-3.7, 0.6]
Comparison: Serotype 18C95% CI: [-0.5, 2.7]
Comparison: Serotype 19A95% CI: [-1.1, 1.1]
Comparison: Serotype 19F95% CI: [-0.9, 1.4]
Comparison: Serotype 23F95% CI: [-3.2, 1.4]
Comparison: Serotype 895% CI: [0.4, 3.9]
Comparison: Serotype 10A95% CI: [-1.5, 2.7]
Comparison: Serotype 11A95% CI: [-0.7, 3.2]
Comparison: Serotype 12F95% CI: [-2.9, 1.6]
Comparison: Serotype 15B95% CI: [0.7, 4.1]
Comparison: Serotype 22F95% CI: [0.4, 3.9]
Comparison: Serotype 33F95% CI: [-0.4, 3.4]
Secondary
Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort
Predefined IgG concentrations were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: \>=0.35 mcg/mL, for serotype 5: \>=0.23 mcg/mL, for serotype 6B: \>=0.10 mcg/mL and for serotype 19A: \>=0.12 mcg/mL. 95% CI was based on the Clopper and Pearson method.
Time frame: 1 Month after Dose 3
Population: Dose 3 evaluable immunogenicity population = eligible participants 42-70 days of age at first vaccination, received all 3 doses as randomized with 335-455 days of age at Dose 3, at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, no major protocol deviations. Here, Number of Participants Analyzed= participants in Dose 3 evaluable immunogenicity population; Number Analyzed= participants with valid IgG results for specified serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 1 | 90.9 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 3 | 68.2 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 4 | 95.5 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 5 | 90.9 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 6A | 95.5 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 6B | 90.9 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 7F | 95.5 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 9V | 100.0 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 14 | 90.9 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 18C | 90.9 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 19A | 100.0 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 19F | 100.0 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 23F | 90.9 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 8 | 68.2 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 10A | 68.2 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 11A | 77.3 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 12F | 36.4 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 15B | 90.9 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 22F | 63.6 Percentage of participants |
| 20vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 33F | 72.7 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 15B | 20.8 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 1 | 83.3 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 19A | 95.8 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 3 | 50.0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 11A | 20.8 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 4 | 100.0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 19F | 91.7 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 5 | 91.7 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 33F | 20.8 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 6A | 100.0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 23F | 79.2 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 6B | 91.7 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 12F | 4.2 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 7F | 100.0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 8 | 25.0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 9V | 83.3 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 22F | 12.5 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 14 | 100.0 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 10A | 16.7 Percentage of participants |
| 13vPnC: Primary Study Population | Percentage of Participants With Predefined Pneumococcal IgG Antibody 1 Month After Dose 3: Russian Cohort | Serotype 18C | 95.8 Percentage of participants |