| Primary | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | The geometric mean concentration (GMC) of immunoglobulin G (IgG) serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13®; and two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-pneumococcal polysaccharides (PnPs) serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL) assay. The within-group 95% confidence intervals (CIs) were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution. | The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | 30 days post last vaccination | | | | ID | Title | Description |
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| OG000 | V114, Schedule A: Participants 7-11 Months | Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine [PCV]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age. | | OG001 | Prevnar 13®, Schedule A: Participants 7-11 Months | Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age. |
| | | Title | Denominators | Categories |
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| Serotype 1 | - ParticipantsOG00060
- ParticipantsOG00159
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| Primary | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13®; and two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL) assay. The within-group 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution. | The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | 30 days post last vaccination | | | | ID | Title | Description |
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| OG000 | V114, Schedule B: Participants 12-23 Months | Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1. | | OG001 | Prevnar 13®, Schedule B: Participants 12-23 Months | Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1. |
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| Primary | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13®; and two serotypes (22F and 33F) which are unique to V114 was determined. Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using pneumococcal electrochemiluminescence (PnECL) assay. The within-group 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution. | The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | 30 days post vaccination | | | | ID | Title | Description |
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| OG000 | V114, Schedule C: Participants 2-17 Years | Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced. | | OG001 | Prevnar 13®, Schedule C: Participants 2-17 Years | Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced. |
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| Primary | Percentage of Participants With Solicited Injection-site Adverse Events - Schedule A: 7-11 Months | An adverse event (AE) is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, hardness/induration, swelling, and pain) was summarized. | The analysis population included all randomized participants who received at least 1 dose of study intervention. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to 14 days post any vaccination | | | | ID | Title | Description |
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| OG000 | V114, Schedule A: Participants 7-11 Months | Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine [PCV]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age. | | OG001 | Prevnar 13®, Schedule A: Participants 7-11 Months | Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age. |
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| Primary | Percentage of Participants With Solicited Injection-site AEs - Schedule B: 12-23 Months | An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, hardness/induration, swelling, and pain) was summarized. | The analysis population included all randomized participants who received at least 1 dose of study intervention. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to 14 days post any vaccination | | | | ID | Title | Description |
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| OG000 | V114, Schedule B: Participants 12-23 Months | Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1. | | OG001 | Prevnar 13®, Schedule B: Participants 12-23 Months | Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1. |
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| Primary | Percentage of Participants With Solicited Injection-site AEs - Schedule C: 2-17 Years | An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 14 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (redness/erythema, hardness/induration, swelling, and pain) was summarized. | The analysis population included all randomized participants who received 1 dose of study intervention. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to 14 days post vaccination | | | | ID | Title | Description |
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| OG000 | V114, Schedule C: Participants 2-17 Years | Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced. | | OG001 | Prevnar 13®, Schedule C: Participants 2-17 Years | Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced. |
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| Primary | Percentage of Participants With Solicited Systemic AEs - Schedule A: 7-11 Months | An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any VRC-prompted systemic AEs that occurred in the 14 days after any vaccination. For participants 7 months to <3 years of age at enrollment, solicited systemic AEs include irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria. The percentage of participants with a systemic AE was summarized. | The analysis population included all randomized participants who received at least 1 dose of study intervention. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to 14 days post any vaccination | | | | ID | Title | Description |
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| OG000 | V114, Schedule A: Participants 7-11 Months | Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine [PCV]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age. | | OG001 | Prevnar 13®, Schedule A: Participants 7-11 Months | Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age. |
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| Primary | Percentage of Participants With Solicited Systemic AEs - Schedule B: 12-23 Months | An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any VRC-prompted systemic AEs that occurred in the 14 days after any vaccination. For participants 7 months to <3 years of age at enrollment, solicited systemic AEs include irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria. The percentage of participants with a systemic AE was summarized. | The analysis population included all randomized participants who received at least 1 dose of study intervention. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to 14 days post any vaccination | | | | ID | Title | Description |
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| OG000 | V114, Schedule B: Participants 12-23 Months | Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1. | | OG001 | Prevnar 13®, Schedule B: Participants 12-23 Months | Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1. |
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| Primary | Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years | An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. The parent/guardian of the participant recorded the presence of any VRC-prompted systemic AEs that occurred in the 14 days after any vaccination. For participants 7 months to <3 years of age at enrollment, solicited systemic AEs include irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria. For participants ≥3 years of age at enrollment, solicited systemic AEs include muscle pain/ myalgia, joint pain/arthralgia, headache, tiredness/fatigue, and hives or welts/urticaria. The percentage of participants with a systemic AE was summarized. | The analysis population included all randomized participants who received 1 dose of study intervention. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to 14 days post vaccination | | | | ID | Title | Description |
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| OG000 | V114, Schedule C: Participants 2-17 Years | Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced. | | OG001 | Prevnar 13®, Schedule C: Participants 2-17 Years | |
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| Primary | Percentage of Participants With at Least 1 Vaccine-related Serious Adverse Event - Schedule A: 7-11 Months | A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan. | The analysis population included all randomized participants who received at least 1 dose of study intervention. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to ~6 months post final vaccination | | | | ID | Title | Description |
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| OG000 | V114, Schedule A: Participants 7-11 Months | Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine [PCV]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age. | | OG001 | Prevnar 13®, Schedule A: Participants 7-11 Months | Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age. |
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| Primary | Percentage of Participants With at Least 1 Vaccine-related SAE - Schedule B: 12-23 Months | A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan. | The analysis population included all randomized participants who received at least 1 dose of study intervention. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to ~6 months post final vaccination | | | | ID | Title | Description |
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| OG000 | V114, Schedule B: Participants 12-23 Months | Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1. | | OG001 | Prevnar 13®, Schedule B: Participants 12-23 Months | Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1. |
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| Primary | Percentage of Participants With at Least 1 Vaccine-related SAE - Schedule C: 2-17 Years | A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized. | The analysis population included all randomized participants who received at least 1 dose of study intervention. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to ~6 months post vaccination | | | | ID | Title | Description |
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| OG000 | V114, Schedule C: Participants 2-17 Years | Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced. | | OG001 | Prevnar 13®, Schedule C: Participants 2-17 Years | Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced. |
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| Secondary | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule A: 7-11 Months | Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL assay. The percentage that achieved the IgG threshold value of ≥0.35 μg/mL was summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan. | The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 30 days post final vaccination | | | | ID | Title | Description |
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| OG000 | V114, Schedule A: Participants 7-11 Months | Each participant received a 0.5 mL intramuscular (IM) injection for 7 to 11 months of age (Pneumococcal conjugate vaccine [PCV]-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age. | | OG001 | Prevnar 13®, Schedule A: Participants 7-11 Months | Each participant received a 0.5 mL IM injection for 7 to 11 months of age (PCV-naïve)(3 doses). Dose 1: at randomization, Dose 2: 4 to 8 weeks after Dose 1, and Dose 3: 8 to 12 weeks after Dose 2 and ≥12 months of age. |
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| Secondary | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule B: 12-23 Months | Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL assay. The percentage that achieved the IgG threshold value of ≥0.35 μg/mL was summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan. The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint. | The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 30 days post final vaccination | | | | ID | Title | Description |
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| OG000 | V114, Schedule B: Participants 12-23 Months | Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1. | | OG001 | Prevnar 13®, Schedule B: Participants 12-23 Months | Each participant received a 0.5 mL IM injection for 12 to 23 months of age (PCV-naïve)(2 doses). Dose 1: at randomization, and Dose 2: 8 to 12 weeks after Dose 1. |
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| Secondary | Percentage of Participants Meeting Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each of the 15 Serotypes - Schedule C: 2-17 Years | Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for all the 15 serotypes using PnECL assay. The percentage that achieved the IgG threshold value of ≥0.35 μg/mL was summarized. Estimated within-group CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan. | The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 30 days post vaccination | | | | ID | Title | Description |
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| OG000 | V114, Schedule C: Participants 2-17 Years | Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced) (1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced. | | OG001 | Prevnar 13®, Schedule C: Participants 2-17 Years | Each participant received a 0.5 mL IM injection for 2 to 17 years of age (PCV-naïve or PCV-experienced)(1 dose). Single dose administered at randomization and at least 8 weeks after previous PCV for participants who were PCV-experienced. |
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