| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 days after Dose 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
|---|
| Redness: Mild | | | Title | Measurements |
|---|
| - OG00020.7± 17.6(17.6 to 24.2)
- OG00122.7± 19.4(19.4 to 26.3)
|
| | Redness: Moderate | | |
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 days after Dose 2 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 days after Dose 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 Days after Dose 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 Days after Dose 2 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 Days after Dose 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 |
|
| 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. | Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From Dose 1 to 1 month after Dose 2 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From Dose 3 to 1 month after Dose 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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. | Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From Dose 1 to 1 month after Dose 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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. | Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From Dose 1 to 1 month after Dose 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 1 month after Dose 2 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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). | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Microgram per millilitre (mcg/mL) | | 1 month after Dose 2 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 |
|
| 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). | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Microgram per millilitre (mcg/mL) | | 1 month after Dose 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 1 month after Dose 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Arbitrary units per millilitre | | 1 month after Dose 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 13vPnC: Primary Study Population | |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Arbitrary units per millilitre | | 1 month after Dose 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 13vPnC: Primary Study Population | |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | International units per millilitre | | 1 month after Dose 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 13vPnC: Primary Study Population | |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Milli-international units per millilitre | | 1 month after Dose 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 13vPnC: Primary Study Population | |
|
| 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. | 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 | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 days after Dose 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 days after Dose 2 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 days after Dose 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 Days after Dose 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 13vPnC: Russian Cohort |
|
| 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. | 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 | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 Days after Dose 2 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 13vPnC: Russian Cohort |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 Days after Dose 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 13vPnC: Russian Cohort |
|
| 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. | Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From Dose 1 to 1 month after Dose 2 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From Dose 3 to 1 month after Dose 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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. | Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From Dose 1 to 1 month after Dose 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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. | Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From Dose 1 to 1 month after Dose 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 1 month after Dose 2 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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). | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Microgram per millilitre (mcg/mL) | | 1 month after Dose 2 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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). | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Microgram per millilitre (mcg/mL) | | 1 month after Dose 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 1 Month after Dose 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 1 month after Dose 2 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 1 Month after Dose 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 13vPnC: Primary Study Population | |
|
| 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). | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Fold rise | | Before Dose 3 to 1 month after Dose 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 1 month after Dose 2 | | | | ID | Title | Description |
|---|
| OG000 | 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. | |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 1 Month after Dose 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 1 month after Dose 2 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 1 Month after Dose 3 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|