Pneumococcal Infections
Conditions
Brief summary
The purpose of this study is 1) to evaluate the safety and tolerability of V114 with respect to the proportion of participants with adverse events (AEs) and 2) to evaluate the anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 30 days following the last dose for each vaccination group. There is no formal hypothesis testing in this study.
Interventions
BIOLOGICALV114
V114 15-valent PCV containing 13 serotypes present in Prevnar 13® (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL IM administration
BIOLOGICALPrevnar 13®
Prevnar 13® 13-valent PCV containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
7 Months to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Not be pregnant or breastfeeding * Not be a woman of childbearing potential * If of a woman of childbearing potential, agree to follow the contraceptive guidance during the treatment period and for at least 6 weeks after the last dose of study intervention * Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent
Exclusion criteria
* History of invasive pneumococcal disease (IPD) * Known hypersensitivity to any component of the PCV or any diphtheria toxoid-containing vaccine * Had a recent febrile illness occurring within 72 hours prior to receipt of study vaccine * Known or suspected impairment of immunological function * History of congenital or acquired immunodeficiency * Has or his/her mother has a documented human immunodeficiency virus (HIV) infection * Known or history of functional or anatomic asplenia * Has failure to thrive based on the clinical judgement of the investigator * Has a bleeding disorder contraindicating intramuscular vaccination * Has a history of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or other autoimmune disorders) * Has known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders * Is 7 to 23 months of age and has received a dose of a pneumococcal vaccine prior to study entry based on medical record. Participants ≥2 years of age could have received a PCV at least 8 weeks prior to study entry as follows: a partial regimen of Prevnar™,Synflorix™, or Prevnar 13™ or a full regimen of Prevnar™ or Synflorix™ based on local guidelines. Participants should not have received any dose of a pneumococcal polysaccharide vaccine * Meets one or more of the following systemic corticosteroid
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least 1 Vaccine-related SAE - Schedule C: 2-17 Years | Up to ~6 months post vaccination | 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. |
| Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years | Up to 14 days post vaccination | 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. |
| Percentage of Participants With at Least 1 Vaccine-related Serious Adverse Event - Schedule A: 7-11 Months | Up to ~6 months post final vaccination | 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. |
| Percentage of Participants With at Least 1 Vaccine-related SAE - Schedule B: 12-23 Months | Up to ~6 months post final vaccination | 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. |
| Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | 30 days post last vaccination | 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. |
| GMC of Serotype-specific IgG - Schedule B: 12-23 Months | 30 days post last vaccination | 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. |
| GMC of Serotype-specific IgG - Schedule C: 2-17 Years | 30 days post vaccination | 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. |
| Percentage of Participants With Solicited Injection-site Adverse Events - Schedule A: 7-11 Months | Up to 14 days post any vaccination | 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. |
| Percentage of Participants With Solicited Injection-site AEs - Schedule B: 12-23 Months | Up to 14 days post any vaccination | 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. |
| Percentage of Participants With Solicited Injection-site AEs - Schedule C: 2-17 Years | Up to 14 days post vaccination | 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. |
| Percentage of Participants With Solicited Systemic AEs - Schedule A: 7-11 Months | Up to 14 days post any vaccination | 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. |
| Percentage of Participants With Solicited Systemic AEs - Schedule B: 12-23 Months | Up to 14 days post any vaccination | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 30 days post final vaccination | 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. |
| 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 | 30 days post vaccination | 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. |
| 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 | 30 days post final vaccination | 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. |
Countries
Finland, Malaysia, Poland, Russia, Thailand
Participant flow
Pre-assignment details
A total of approximately 600 participants were planned for enrollment. Randomization was stratified by age and pneumococcal conjugate vaccine (PCV) history.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 64 |
| 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. | 64 |
| 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. | 62 |
| 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. | 64 |
| 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. | 177 |
| 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. | 175 |
| Total | 606 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Withdrawn by Parent/Guardian | 1 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | V114, Schedule A: Participants 7-11 Months | Total | Prevnar 13®, Schedule C: Participants 2-17 Years | V114, Schedule C: Participants 2-17 Years | Prevnar 13®, Schedule B: Participants 12-23 Months | V114, Schedule B: Participants 12-23 Months | Prevnar 13®, Schedule A: Participants 7-11 Months |
|---|---|---|---|---|---|---|---|
| Age, Customized 12-23 Months | 0 Participants | 126 Participants | 0 Participants | 0 Participants | 64 Participants | 62 Participants | 0 Participants |
| Age, Customized ≥2 to <6 Years | 0 Participants | 226 Participants | 112 Participants | 114 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized ≥6 to 17 Years | 0 Participants | 126 Participants | 63 Participants | 63 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 7-11 Months | 64 Participants | 128 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 64 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 64 Participants | 603 Participants | 174 Participants | 176 Participants | 63 Participants | 62 Participants | 64 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 53 Participants | 327 Participants | 56 Participants | 60 Participants | 53 Participants | 52 Participants | 53 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 278 Participants | 118 Participants | 117 Participants | 11 Participants | 10 Participants | 11 Participants |
| Sex: Female, Male Female | 29 Participants | 298 Participants | 83 Participants | 85 Participants | 38 Participants | 30 Participants | 33 Participants |
| Sex: Female, Male Male | 35 Participants | 308 Participants | 92 Participants | 92 Participants | 26 Participants | 32 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 64 | 0 / 62 | 0 / 64 | 0 / 177 | 0 / 175 |
| other Total, other adverse events | 44 / 64 | 47 / 64 | 46 / 62 | 36 / 64 | 125 / 177 | 125 / 175 |
| serious Total, serious adverse events | 7 / 64 | 5 / 64 | 4 / 62 | 4 / 64 | 4 / 177 | 4 / 175 |
Outcome results
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.
Time frame: 30 days post last vaccination
Population: The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 6A | 2.23 μg/mL |
| V114, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 14 | 9.62 μg/mL |
| V114, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 3 | 2.65 μg/mL |
| V114, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 18C | 3.45 μg/mL |
| V114, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 6B | 3.03 μg/mL |
| V114, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 19A | 4.59 μg/mL |
| V114, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 5 | 3.82 μg/mL |
| V114, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 19F | 3.49 μg/mL |
| V114, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 7F | 5.16 μg/mL |
| V114, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 23F | 2.62 μg/mL |
| V114, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 4 | 2.21 μg/mL |
| V114, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 22F | 9.04 μg/mL |
| V114, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 9V | 2.61 μg/mL |
| V114, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 33F | 3.37 μg/mL |
| V114, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 1 | 2.47 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 33F | 0.13 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 1 | 3.66 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 3 | 1.71 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 4 | 3.85 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 5 | 4.56 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 6A | 4.30 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 6B | 4.17 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 7F | 6.42 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 9V | 3.59 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 14 | 13.07 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 18C | 3.50 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 19A | 5.81 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 19F | 4.83 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 23F | 2.79 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Geometric Mean Concentration of Serotype-specific Immunoglobulin G - Schedule A: 7-11 Months | Serotype 22F | 0.14 μg/mL |
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.
Time frame: 30 days post last vaccination
Population: The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 6A | 2.05 μg/mL |
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 14 | 8.23 μg/mL |
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 3 | 2.96 μg/mL |
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 18C | 5.09 μg/mL |
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 6B | 2.69 μg/mL |
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 19A | 6.74 μg/mL |
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 5 | 3.39 μg/mL |
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 19F | 5.90 μg/mL |
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 7F | 4.80 μg/mL |
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 23F | 2.85 μg/mL |
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 4 | 3.46 μg/mL |
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 22F | 15.90 μg/mL |
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 9V | 2.48 μg/mL |
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 33F | 5.17 μg/mL |
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 1 | 3.83 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 33F | 0.15 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 1 | 4.20 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 3 | 1.68 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 4 | 4.89 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 5 | 3.12 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 6A | 3.73 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 6B | 2.87 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 7F | 5.42 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 9V | 2.89 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 14 | 8.30 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 18C | 3.68 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 19A | 5.87 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 19F | 5.92 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 23F | 2.18 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule B: 12-23 Months | Serotype 22F | 0.12 μg/mL |
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.
Time frame: 30 days post vaccination
Population: The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 6A | 9.03 μg/mL |
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 14 | 9.21 μg/mL |
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 3 | 1.37 μg/mL |
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 18C | 7.16 μg/mL |
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 6B | 13.55 μg/mL |
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 19A | 10.99 μg/mL |
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 5 | 3.43 μg/mL |
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 19F | 8.95 μg/mL |
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 7F | 4.03 μg/mL |
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 23F | 5.36 μg/mL |
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 4 | 2.53 μg/mL |
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 22F | 14.99 μg/mL |
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 9V | 3.60 μg/mL |
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 33F | 4.89 μg/mL |
| V114, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 1 | 3.00 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 33F | 0.27 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 1 | 3.99 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 3 | 1.03 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 4 | 5.22 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 5 | 4.24 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 6A | 8.81 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 6B | 10.51 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 7F | 4.63 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 9V | 4.35 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 14 | 8.04 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 18C | 4.46 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 19A | 14.90 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 19F | 12.28 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 23F | 5.12 μg/mL |
| Prevnar 13®, Schedule A: Participants 7-11 Months | GMC of Serotype-specific IgG - Schedule C: 2-17 Years | Serotype 22F | 0.31 μg/mL |
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.
Time frame: Up to ~6 months post final vaccination
Population: The analysis population included all randomized participants who received at least 1 dose of study intervention.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With at Least 1 Vaccine-related SAE - Schedule B: 12-23 Months | 0.0 Percentage of Participants | 95% Confidence Interval 0 |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With at Least 1 Vaccine-related SAE - Schedule B: 12-23 Months | 0.0 Percentage of Participants | 95% Confidence Interval 0 |
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.
Time frame: Up to ~6 months post vaccination
Population: The analysis population included all randomized participants who received at least 1 dose of study intervention.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With at Least 1 Vaccine-related SAE - Schedule C: 2-17 Years | 0.0 Percentage of Participants | 95% Confidence Interval 0 |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With at Least 1 Vaccine-related SAE - Schedule C: 2-17 Years | 0.0 Percentage of Participants | 95% Confidence Interval 0 |
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.
Time frame: Up to ~6 months post final vaccination
Population: The analysis population included all randomized participants who received at least 1 dose of study intervention.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With at Least 1 Vaccine-related Serious Adverse Event - Schedule A: 7-11 Months | 0.0 Percentage of Participants | 95% Confidence Interval 0 |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With at Least 1 Vaccine-related Serious Adverse Event - Schedule A: 7-11 Months | 0.0 Percentage of Participants | 95% Confidence Interval 0 |
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.
Time frame: Up to 14 days post any vaccination
Population: The analysis population included all randomized participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Injection-site Adverse Events - Schedule A: 7-11 Months | Redness/Erythema | 28.1 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Injection-site Adverse Events - Schedule A: 7-11 Months | Hardness/Induration | 17.2 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Injection-site Adverse Events - Schedule A: 7-11 Months | Pain | 18.8 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Injection-site Adverse Events - Schedule A: 7-11 Months | Swelling | 18.8 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Injection-site Adverse Events - Schedule A: 7-11 Months | Swelling | 15.6 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Injection-site Adverse Events - Schedule A: 7-11 Months | Redness/Erythema | 34.4 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Injection-site Adverse Events - Schedule A: 7-11 Months | Pain | 7.8 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Injection-site Adverse Events - Schedule A: 7-11 Months | Hardness/Induration | 14.1 Percentage of Participants |
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.
Time frame: Up to 14 days post any vaccination
Population: The analysis population included all randomized participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Injection-site AEs - Schedule B: 12-23 Months | Redness/Erythema | 21.0 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Injection-site AEs - Schedule B: 12-23 Months | Hardness/Induration | 8.1 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Injection-site AEs - Schedule B: 12-23 Months | Pain | 33.9 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Injection-site AEs - Schedule B: 12-23 Months | Swelling | 14.5 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Injection-site AEs - Schedule B: 12-23 Months | Swelling | 12.5 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Injection-site AEs - Schedule B: 12-23 Months | Redness/Erythema | 21.9 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Injection-site AEs - Schedule B: 12-23 Months | Pain | 23.4 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Injection-site AEs - Schedule B: 12-23 Months | Hardness/Induration | 9.4 Percentage of Participants |
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.
Time frame: Up to 14 days post vaccination
Population: The analysis population included all randomized participants who received 1 dose of study intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Injection-site AEs - Schedule C: 2-17 Years | Redness/Erythema | 19.2 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Injection-site AEs - Schedule C: 2-17 Years | Hardness/Induration | 6.8 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Injection-site AEs - Schedule C: 2-17 Years | Pain | 54.8 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Injection-site AEs - Schedule C: 2-17 Years | Swelling | 20.9 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Injection-site AEs - Schedule C: 2-17 Years | Swelling | 24.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Injection-site AEs - Schedule C: 2-17 Years | Redness/Erythema | 21.1 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Injection-site AEs - Schedule C: 2-17 Years | Pain | 56.6 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Injection-site AEs - Schedule C: 2-17 Years | Hardness/Induration | 14.9 Percentage of Participants |
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.
Time frame: Up to 14 days post any vaccination
Population: The analysis population included all randomized participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule A: 7-11 Months | Appetite lost/Decreased appetite | 15.6 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule A: 7-11 Months | Irritability | 32.8 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule A: 7-11 Months | Drowsiness/Somnolence | 21.9 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule A: 7-11 Months | Hives or Welts/Urticaria | 1.6 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule A: 7-11 Months | Hives or Welts/Urticaria | 4.7 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule A: 7-11 Months | Appetite lost/Decreased appetite | 18.8 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule A: 7-11 Months | Drowsiness/Somnolence | 15.6 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule A: 7-11 Months | Irritability | 43.8 Percentage of Participants |
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.
Time frame: Up to 14 days post any vaccination
Population: The analysis population included all randomized participants who received at least 1 dose of study intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule B: 12-23 Months | Appetite lost/Decreased appetite | 22.6 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule B: 12-23 Months | Irritability | 35.5 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule B: 12-23 Months | Drowsiness/Somnolence | 24.2 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule B: 12-23 Months | Hives or Welts/Urticaria | 0.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule B: 12-23 Months | Hives or Welts/Urticaria | 0.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule B: 12-23 Months | Appetite lost/Decreased appetite | 18.8 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule B: 12-23 Months | Drowsiness/Somnolence | 17.2 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule B: 12-23 Months | Irritability | 21.9 Percentage of Participants |
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.
Time frame: Up to 14 days post vaccination
Population: The analysis population included all randomized participants who received 1 dose of study intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years | Joint pain/arthralgia | 0.0 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years | Appetite lost/Decreased appetite | 2.3 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years | Tiredness/Fatigue | 15.8 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years | Headache | 11.9 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years | Irritability | 2.8 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years | Muscle pain/Myalgia | 23.7 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years | Drowsiness/Somnolence | 2.8 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years | Hives or Welts/Urticaria | 1.1 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years | Hives or Welts/Urticaria | 1.1 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years | Joint pain/arthralgia | 1.7 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years | Irritability | 4.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years | Appetite lost/Decreased appetite | 2.9 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years | Drowsiness/Somnolence | 2.9 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years | Tiredness/Fatigue | 17.1 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years | Muscle pain/Myalgia | 16.6 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | Percentage of Participants With Solicited Systemic AEs - Schedule C: 2-17 Years | Headache | 13.7 Percentage of Participants |
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.
Time frame: 30 days post final vaccination
Population: The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 6A | 95.0 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 14 | 100.0 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 3 | 100.0 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 18C | 100.0 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 6B | 96.7 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 19A | 100.0 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 5 | 100.0 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 19F | 100.0 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 7F | 100.0 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 23F | 98.3 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 4 | 100.0 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 22F | 100.0 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 9V | 98.3 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 33F | 100.0 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 1 | 100.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 33F | 11.9 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 1 | 100.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 3 | 96.6 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 4 | 100.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 5 | 100.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 6A | 98.3 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 6B | 100.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 7F | 100.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 9V | 100.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 14 | 100.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 18C | 100.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 19A | 100.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 19F | 100.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 23F | 100.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 22F | 13.8 Percentage of Participants |
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.
Time frame: 30 days post final vaccination
Population: The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 6A (n=56,60) | 83.9 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 14 (n=56,60) | 98.2 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 3 (n=56,60) | 98.2 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 18C (n=56,60) | 96.4 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 6B (n=56,60) | 89.3 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 19A (n=56,60) | 98.2 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 5 (n=56,60) | 98.2 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 19F (n=56,60) | 100.0 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 7F (n=56,60) | 98.2 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 23F (n=56,60) | 94.6 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 4 (n=56,60) | 100.0 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 22F (n=56,60) | 100.0 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 9V (n=56,60) | 98.2 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 33F (n=56,60) | 94.6 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 1 | 100.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 33F (n=56,60) | 15.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 1 | 98.3 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 3 (n=56,60) | 90.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 4 (n=56,60) | 96.7 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 5 (n=56,60) | 98.3 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 6A (n=56,60) | 95.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 6B (n=56,60) | 88.3 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 7F (n=56,60) | 100.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 9V (n=56,60) | 96.7 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 14 (n=56,60) | 100.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 18C (n=56,60) | 98.3 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 19A (n=56,60) | 100.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 19F (n=56,60) | 100.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 23F (n=56,60) | 88.3 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 22F (n=56,60) | 6.7 Percentage of Participants |
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.
Time frame: 30 days post vaccination
Population: The analysis population included all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 6A | 98.1 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 14 | 99.4 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 3 | 95.7 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 18C | 100.0 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 6B | 98.1 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 19A | 100.0 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 5 | 99.4 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 19F | 99.4 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 7F | 99.4 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 23F | 99.4 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 4 | 98.8 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 22F | 100.0 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 9V | 100.0 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 33F | 99.4 Percentage of Participants |
| V114, Schedule A: Participants 7-11 Months | 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 | Serotype 1 | 99.4 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 33F | 37.5 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 1 | 100.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 3 | 87.7 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 4 | 100.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 5 | 99.4 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 6A | 98.1 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 6B | 96.9 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 7F | 100.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 9V | 98.8 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 14 | 98.1 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 18C | 100.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 19A | 100.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 19F | 100.0 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 23F | 95.7 Percentage of Participants |
| Prevnar 13®, Schedule A: Participants 7-11 Months | 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 | Serotype 22F | 37.7 Percentage of Participants |