Pneumococcal Infections
Conditions
Brief summary
This study is designed 1) to evaluate the safety, tolerability, and immunogenicity of V114 and Prevnar 13™, 2) to describe the safety of sequential administration of V114 or Prevnar 13™ followed by PNEUMOVAX™23, and 3) to evaluate the immune responses to the 15 serotypes contained in V114 when PNEUMOVAX™23 is given approximately 12 months after receipt of either V114 or Prevnar 13™ in healthy adults 50 years of age or older. There was no formal hypothesis testing.
Interventions
BIOLOGICALV114
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose
BIOLOGICALPrevnar 13™
13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose
BIOLOGICALPNEUMOVAX™23
23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female in good health * Female participant: not pregnant, not breastfeeding and 1) not of childbearing potential, or 2) of childbearing potential and agrees to practice contraception through 6 weeks after administration of last study vaccine.
Exclusion criteria
* History of invasive pneumococcal disease * Known hypersensitivity to any component of pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine. * Known or suspected impairment of immune function * Coagulation disorder contraindicating intramuscular vaccination * History of malignancy ≤5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer * Female participant: positive urine or serum pregnancy test * Prior administration of any pneumococcal vaccine * Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention at least 30 days before study entry. * Received systemic corticosteroids exceeding physiologic replacement doses (approximately 5 mg/day prednisone equivalent) within 14 days before vaccination. (Note: Topical, ophthalmic, intra-articular or soft-tissue \[e.g., bursa, tendon steroid injections\], and inhaled/nebulized steroids are permitted). * Received immunosuppressive therapy * Received a blood transfusion or blood products within 6 months of enrollment * Participated in another clinical study of an investigational product within 2 months of enrollment * Current user of recreational or illicit drugs or history of drug or alcohol abuse or dependence.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™ | Up to 5 days after Vaccination 1 | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. |
| Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23 | Up to 5 days after Vaccination 2 | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following vaccination with PNEUMOVAX™23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. |
| Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™ | Up to 14 days after Vaccination 1 | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. |
| Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23 | Up to 14 days after Vaccination 2 | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following vaccination with PNEUMOVAX™23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. |
| Percentage of Participants With Vaccine-related Serious Adverse Events Following V114 or Prevnar 13™ | Up to 12 months after Vaccination 1 | A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine will be determined by the investigator. Following vaccination with V114 or Prevnar 13™, the percentage of participants with vaccine-related serious adverse events was assessed. |
| Percentage of Participants With Vaccine-related Serious Adverse Events Following PNEUMOVAX™23 | Month 12 to Month 13 (Up to 44 days after Vaccination 2) | A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine will be determined by the investigator. Following vaccination with PNEUMOVAX™23, the percentage of participants with vaccine-related serious adverse events was assessed. |
| Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Month 13 (30 days after Vaccination 2) | Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) (estimated) and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated. OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMT of Serotype-specific OPA at Month 12 | Month 12 | Serotype-specific OPA GMTs (estimated) and GMT ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated. OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay. |
| GMC of Serotype-specific IgG at Month 12 | Month 12 | Serotype-specific IgG GMC (estimated) and GMC ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMC ratios); within-group CIs were not calculated. IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. |
| GMFR in Serotype-specific OPA Day 1 to Month 12 | Day 1 (Baseline) and Month 12 | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination. |
| GMFR in Serotype-specific IgG Day 1 to Month 12 | Day 1 (Baseline) and Month 12 | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. |
| Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Day 1 (Baseline) and Month 12 | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination. |
| Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Day 1 (Baseline) and Month 12 | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination. |
| GMFR in Serotype-specific OPA Day 1 to Month 13 | Day 1 (Baseline) and Month 13 | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination. |
| Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Month 13 (30 days after Vaccination 2) | Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) (estimated) and GMC ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMC ratios); within-group CIs were not calculated. IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. |
| Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Day 1 (Baseline) and Month 13 | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination. |
| Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Day 1 (Baseline) and Month 13 | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination. |
| GMFR in Serotype-specific OPA Month 12 to Month 13 | Month 12 (Baseline) and Month 13 | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination. |
| GMFR in Serotype-specific IgG Month 12 to Month 13 | Month 12 (Baseline) and Month 13 | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. |
| Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Month 12 (Baseline) and Month 13 | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination. |
| Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Month 12 (Baseline) and Month 13 | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination. |
| GMFR in Serotype-specific IgG Day 1 to Month 13 | Day 1 (Baseline) and Month 13 | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. |
| GMT of Serotype-specific OPA at Day 30 | Day 30 | Serotype-specific OPA GMTs (estimated) and GMT ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated. OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay. |
| GMC of Serotype-specific IgG at Day 30 | Day 30 | Serotype-specific IgG GMC (estimated) and GMC ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMC ratios); within-group CIs were not calculated. IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. |
| Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Day 1 (Baseline) and Day 30 | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination. |
| GMFR in Serotype-specific IgG Day 1 to Day 30 | Day 1 (Baseline) and Day 30 | Activity for the serotypes contained in Prevnar 13™ and V114 and (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination. |
| Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Day 1 (Baseline) and Day 30 | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination. |
| Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Day 1 (Baseline) and Day 30 | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination. |
Countries
South Korea, Spain, Taiwan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| V114 Participants were to receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2). | 327 |
| Prevnar 13™ Participants were to receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Month 12 (Vaccination 2). | 325 |
| Total | 652 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 7 |
| Overall Study | non-study pneumococcal vaccine | 1 | 0 |
| Overall Study | oncological treatment | 0 | 2 |
| Overall Study | pain with vaccination | 1 | 0 |
| Overall Study | Withdrawal by Subject | 18 | 10 |
Baseline characteristics
| Characteristic | Prevnar 13™ | Total | V114 |
|---|---|---|---|
| Age, Continuous | 64.1 years STANDARD_DEVIATION 8.4 | 64.1 years STANDARD_DEVIATION 8.2 | 64.0 years STANDARD_DEVIATION 8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 37 Participants | 79 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 287 Participants | 570 Participants | 283 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 103 Participants | 206 Participants | 103 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants | 40 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 198 Participants | 401 Participants | 203 Participants |
| Sex: Female, Male Female | 181 Participants | 371 Participants | 190 Participants |
| Sex: Female, Male Male | 144 Participants | 281 Participants | 137 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 327 | 0 / 324 | 0 / 298 | 0 / 302 |
| other Total, other adverse events | 221 / 327 | 181 / 324 | 217 / 298 | 210 / 302 |
| serious Total, serious adverse events | 17 / 327 | 19 / 324 | 1 / 298 | 2 / 302 |
Outcome results
Primary
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23
Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) (estimated) and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated. OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay.
Time frame: Month 13 (30 days after Vaccination 2)
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 5 (Shared) | 705.5 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 14 (Shared) | 3370.9 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 1 (Shared) | 392.2 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 18C (Shared) | 2379.6 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 6A (Shared) | 3261.5 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 19A (Shared) | 3657.1 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 4 (Shared) | 1671.9 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 19F (Shared) | 2229.7 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 6B (Shared) | 3223.9 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 23F (Shared) | 1894.2 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 7F (Shared) | 5125.6 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 22F (Unique to V114) | 3124.4 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 3 (Shared) | 282.6 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 33F (Unique to V114) | 7881.6 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 9V (Shared) | 2059.5 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 33F (Unique to V114) | 8269.9 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 1 (Shared) | 283.2 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 3 (Shared) | 262.8 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 4 (Shared) | 1580.4 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 5 (Shared) | 583.9 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 6A (Shared) | 2806.8 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 7F (Shared) | 4848.0 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 9V (Shared) | 1872.0 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 14 (Shared) | 2660.5 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 18C (Shared) | 2103.9 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 19A (Shared) | 3170.8 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 19F (Shared) | 2156.2 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 23F (Shared) | 1485.1 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 22F (Unique to V114) | 1921.6 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23 | Serotype 6B (Shared) | 2872.0 Titers |
Comparison: Serotype 1 (Shared)95% CI: [1.1, 1.74]
Comparison: Serotype 3 (Shared)95% CI: [0.9, 1.29]
Comparison: Serotype 4 (Shared)95% CI: [0.85, 1.32]
Comparison: Serotype 5 (Shared)95% CI: [0.94, 1.56]
Comparison: Serotype 6A (Shared)95% CI: [0.95, 1.43]
Comparison: Serotype 6B (Shared)95% CI: [0.93, 1.35]
Comparison: Serotype 7F (Shared)95% CI: [0.9, 1.25]
Comparison: Serotype 9V (Shared)95% CI: [0.91, 1.33]
Comparison: Serotype 14 (Shared)95% CI: [1.05, 1.53]
Comparison: Serotype 18C (Shared)95% CI: [0.95, 1.34]
Comparison: Serotype 19A (Shared)95% CI: [0.96, 1.38]
Comparison: Serotype 19F (Shared)95% CI: [0.89, 1.2]
Comparison: Serotype 23F (Shared)95% CI: [1.01, 1.61]
Comparison: Serotype 22F (Unique to V114)95% CI: [1.29, 2.06]
Comparison: Serotype 33F (Unique to V114)95% CI: [0.77, 1.17]
Primary
Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following vaccination with PNEUMOVAX™23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.
Time frame: Up to 5 days after Vaccination 2
Population: The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23 | Injection site redness/erythema | 17.4 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23 | Injection site tenderness/pain | 62.1 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23 | Injection site swelling | 28.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23 | Injection site redness/erythema | 16.9 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23 | Injection site tenderness/pain | 58.6 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23 | Injection site swelling | 26.2 Percentage of Participants |
Comparison: Injection site redness/erythemap-value: 0.85595% CI: [-5.5, 6.6]Miettinen & Nurminen
Comparison: Injection site tenderness/painp-value: 0.38595% CI: [-4.4, 11.3]Miettinen & Nurminen
Comparison: Injection site swellingp-value: 0.57795% CI: [-5.1, 9.2]Miettinen & Nurminen
Primary
Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain.
Time frame: Up to 5 days after Vaccination 1
Population: The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest. (In the Prevnar 13™ group, 324 were vaccinated with Prevnar 13™; 1 was incorrectly vaccinated with V114.)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™ | Injection site redness/erythema | 9.8 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™ | Injection site tenderness/pain | 55.0 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™ | Injection site swelling | 16.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™ | Injection site redness/erythema | 5.6 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™ | Injection site tenderness/pain | 41.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™ | Injection site swelling | 11.4 Percentage of Participants |
Comparison: Injection site redness/erythemap-value: 0.04395% CI: [0.1, 8.5]Miettinen & Nurminen
Comparison: Injection site tenderness/painp-value: <0.00195% CI: [6, 21.2]Miettinen & Nurminen
Comparison: Injection site swellingp-value: 0.07795% CI: [-0.5, 10.2]Miettinen & Nurminen
Primary
Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following vaccination with PNEUMOVAX™23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.
Time frame: Up to 14 days after Vaccination 2
Population: The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23 | Joint pain/arthralgia | 8.4 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23 | Tiredness/fatigue | 25.8 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23 | Headache | 12.1 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23 | Muscle pain/myalgia | 21.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23 | Muscle pain/myalgia | 16.6 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23 | Joint pain/arthralgia | 8.3 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23 | Headache | 12.6 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23 | Tiredness/fatigue | 21.9 Percentage of Participants |
Comparison: Joint pain/arthralgiap-value: 0.96195% CI: [-4.4, 4.7]Miettinen & Nurminen
Comparison: Tiredness/fatiguep-value: 0.25295% CI: [-2.8, 10.8]Miettinen & Nurminen
Comparison: Headachep-value: 0.85295% CI: [-5.8, 4.8]Miettinen & Nurminen
Comparison: Muscle pain/myalgiap-value: 0.12595% CI: [-1.4, 11.2]Miettinen & Nurminen
Primary
Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.
Time frame: Up to 14 days after Vaccination 1
Population: The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest. (In the Prevnar 13™ group, 324 were vaccinated with Prevnar 13™; 1 was incorrectly vaccinated with V114.)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™ | Joint pain/arthralgia | 6.4 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™ | Tiredness/fatigue | 23.5 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™ | Headache | 14.1 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™ | Muscle pain/myalgia | 17.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™ | Muscle pain/myalgia | 11.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™ | Joint pain/arthralgia | 5.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™ | Headache | 12.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™ | Tiredness/fatigue | 13.9 Percentage of Participants |
Comparison: Joint pain/arthralgiap-value: 0.52395% CI: [-2.5, 4.9]Miettinen & Nurminen
Comparison: Tiredness/fatiguep-value: 0.00295% CI: [3.7, 15.6]Miettinen & Nurminen
Comparison: Headachep-value: 0.59795% CI: [-3.9, 6.7]Miettinen & Nurminen
Comparison: Muscle pain/myalgiap-value: 0.01695% CI: [1.2, 12.1]Miettinen & Nurminen
Primary
Percentage of Participants With Vaccine-related Serious Adverse Events Following PNEUMOVAX™23
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine will be determined by the investigator. Following vaccination with PNEUMOVAX™23, the percentage of participants with vaccine-related serious adverse events was assessed.
Time frame: Month 12 to Month 13 (Up to 44 days after Vaccination 2)
Population: The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 | Percentage of Participants With Vaccine-related Serious Adverse Events Following PNEUMOVAX™23 | 0.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Vaccine-related Serious Adverse Events Following PNEUMOVAX™23 | 0.0 Percentage of Participants |
Comparison: Vaccine-related SAEs following PNEUMOVAX™2395% CI: [-1.3, 1.3]
Primary
Percentage of Participants With Vaccine-related Serious Adverse Events Following V114 or Prevnar 13™
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine will be determined by the investigator. Following vaccination with V114 or Prevnar 13™, the percentage of participants with vaccine-related serious adverse events was assessed.
Time frame: Up to 12 months after Vaccination 1
Population: The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest. (In the Prevnar 13™ group, 324 were vaccinated with Prevnar 13™; 1 was incorrectly vaccinated with V114.)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 | Percentage of Participants With Vaccine-related Serious Adverse Events Following V114 or Prevnar 13™ | 0.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Vaccine-related Serious Adverse Events Following V114 or Prevnar 13™ | 0.0 Percentage of Participants |
Comparison: Vaccine-related SAEs following V114 or Prevnar 13™95% CI: [-1.2, 1.2]
Secondary
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23
Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) (estimated) and GMC ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMC ratios); within-group CIs were not calculated. IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay.
Time frame: Month 13 (30 days after Vaccination 2)
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 6A (Shared) | 4.97 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 14 (Shared) | 14.82 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 3 (Shared) | 1.05 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 18C (Shared) | 7.31 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 6B (Shared) | 6.71 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 19A (Shared) | 13.10 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 5 (Shared) | 5.77 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 19F (Shared) | 9.38 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 7F (Shared) | 5.99 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 23F (Shared) | 4.83 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 4 (Shared) | 1.99 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 22F (Unique to V114) | 4.85 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 9V (Shared) | 4.96 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 33F (Unique to V114) | 10.60 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 1 (Shared) | 5.21 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 33F (Unique to V114) | 13.30 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 1 (Shared) | 5.68 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 3 (Shared) | 1.05 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 4 (Shared) | 2.29 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 5 (Shared) | 5.82 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 6A (Shared) | 4.28 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 6B (Shared) | 5.77 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 7F (Shared) | 6.06 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 9V (Shared) | 4.75 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 14 (Shared) | 12.72 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 18C (Shared) | 6.29 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 19A (Shared) | 11.88 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 19F (Shared) | 8.62 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 23F (Shared) | 4.24 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23 | Serotype 22F (Unique to V114) | 3.39 µg/mL |
Comparison: Serotype 1 (Shared)95% CI: [0.79, 1.07]
Comparison: Serotype 3 (Shared)95% CI: [0.87, 1.16]
Comparison: Serotype 4 (Shared)95% CI: [0.74, 1.02]
Comparison: Serotype 5 (Shared)95% CI: [0.84, 1.18]
Comparison: Serotype 6A (Shared)95% CI: [0.96, 1.41]
Comparison: Serotype 6B (Shared)95% CI: [0.96, 1.4]
Comparison: Serotype 7F (Shared)95% CI: [0.85, 1.16]
Comparison: Serotype 9V (Shared)95% CI: [0.89, 1.22]
Comparison: Serotype 14 (Shared)95% CI: [0.98, 1.39]
Comparison: Serotype 18C (Shared)95% CI: [1, 1.36]
Comparison: Serotype 19A (Shared)95% CI: [0.95, 1.29]
Comparison: Serotype 19F (Shared)95% CI: [0.93, 1.27]
Comparison: Serotype 23F (Shared)95% CI: [0.96, 1.35]
Comparison: Serotype 22F (Unique to V114)95% CI: [1.16, 1.77]
Comparison: Serotype 33F (Unique to V114)95% CI: [0.67, 0.95]
Secondary
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
Time frame: Day 1 (Baseline) and Day 30
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 6A (Shared) | 17.4 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 14 (Shared) | 6.6 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 3 (Shared) | 8.0 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 18C (Shared) | 18.1 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 6B (Shared) | 28.5 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 19A (Shared) | 13.4 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 5 (Shared) | 17.2 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 19F (Shared) | 7.8 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 7F (Shared) | 10.7 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 23F (Shared) | 18.8 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 4 (Shared) | 18.3 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 22F (Unique to V114) | 32.5 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 9V (Shared) | 6.1 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 33F (Unique to V114) | 8.3 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 1 (Shared) | 22.3 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 33F (Unique to V114) | 0.9 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 1 (Shared) | 16.7 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 3 (Shared) | 4.4 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 4 (Shared) | 23.3 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 5 (Shared) | 16.2 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 6A (Shared) | 13.9 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 6B (Shared) | 18.4 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 7F (Shared) | 10.5 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 9V (Shared) | 5.6 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 14 (Shared) | 6.0 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 18C (Shared) | 12.2 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 19A (Shared) | 10.0 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 19F (Shared) | 6.4 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 23F (Shared) | 12.2 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 22F (Unique to V114) | 1.1 Ratio |
Secondary
GMC of Serotype-specific IgG at Day 30
Serotype-specific IgG GMC (estimated) and GMC ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMC ratios); within-group CIs were not calculated. IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay.
Time frame: Day 30
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | GMC of Serotype-specific IgG at Day 30 | Serotype 6A (Shared) | 11.48 µg/mL |
| V114 | GMC of Serotype-specific IgG at Day 30 | Serotype 14 (Shared) | 12.68 µg/mL |
| V114 | GMC of Serotype-specific IgG at Day 30 | Serotype 3 (Shared) | 1.02 µg/mL |
| V114 | GMC of Serotype-specific IgG at Day 30 | Serotype 18C (Shared) | 16.67 µg/mL |
| V114 | GMC of Serotype-specific IgG at Day 30 | Serotype 6B (Shared) | 13.69 µg/mL |
| V114 | GMC of Serotype-specific IgG at Day 30 | Serotype 19A (Shared) | 18.59 µg/mL |
| V114 | GMC of Serotype-specific IgG at Day 30 | Serotype 5 (Shared) | 5.43 µg/mL |
| V114 | GMC of Serotype-specific IgG at Day 30 | Serotype 19F (Shared) | 12.00 µg/mL |
| V114 | GMC of Serotype-specific IgG at Day 30 | Serotype 7F (Shared) | 7.14 µg/mL |
| V114 | GMC of Serotype-specific IgG at Day 30 | Serotype 23F (Shared) | 9.76 µg/mL |
| V114 | GMC of Serotype-specific IgG at Day 30 | Serotype 4 (Shared) | 2.36 µg/mL |
| V114 | GMC of Serotype-specific IgG at Day 30 | Serotype 22F (Unique to V114) | 5.07 µg/mL |
| V114 | GMC of Serotype-specific IgG at Day 30 | Serotype 9V (Shared) | 6.10 µg/mL |
| V114 | GMC of Serotype-specific IgG at Day 30 | Serotype 33F (Unique to V114) | 14.31 µg/mL |
| V114 | GMC of Serotype-specific IgG at Day 30 | Serotype 1 (Shared) | 6.97 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Day 30 | Serotype 33F (Unique to V114) | 1.12 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Day 30 | Serotype 1 (Shared) | 7.86 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Day 30 | Serotype 3 (Shared) | 0.59 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Day 30 | Serotype 4 (Shared) | 2.98 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Day 30 | Serotype 5 (Shared) | 5.21 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Day 30 | Serotype 6A (Shared) | 8.22 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Day 30 | Serotype 6B (Shared) | 8.35 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Day 30 | Serotype 7F (Shared) | 7.82 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Day 30 | Serotype 9V (Shared) | 5.39 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Day 30 | Serotype 14 (Shared) | 11.59 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Day 30 | Serotype 18C (Shared) | 10.66 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Day 30 | Serotype 19A (Shared) | 16.48 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Day 30 | Serotype 19F (Shared) | 10.53 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Day 30 | Serotype 23F (Shared) | 6.07 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Day 30 | Serotype 22F (Unique to V114) | 0.31 µg/mL |
Comparison: Serotype 1 (Shared)95% CI: [0.72, 1.09]
Comparison: Serotype 3 (Shared)95% CI: [1.46, 2.07]
Comparison: Serotype 4 (Shared)95% CI: [0.64, 0.99]
Comparison: Serotype 5 (Shared)95% CI: [0.84, 1.3]
Comparison: Serotype 6A (Shared)95% CI: [1.1, 1.77]
Comparison: Serotype 6B (Shared)95% CI: [1.28, 2.1]
Comparison: Serotype 7F (Shared)95% CI: [0.74, 1.13]
Comparison: Serotype 9V (Shared)95% CI: [0.91, 1.41]
Comparison: Serotype 14 (Shared)95% CI: [0.87, 1.38]
Comparison: Serotype 18C (Shared)95% CI: [1.27, 1.92]
Comparison: Serotype 19A (Shared)95% CI: [0.91, 1.39]
Comparison: Serotype 19F (Shared)95% CI: [0.92, 1.41]
Comparison: Serotype 23F (Shared)95% CI: [1.27, 2.04]
Comparison: Serotype 22F (Unique to V114)95% CI: [13.78, 19.86]
Comparison: Serotype 33F (Unique to V114)95% CI: [10.82, 15.19]
Secondary
GMC of Serotype-specific IgG at Month 12
Serotype-specific IgG GMC (estimated) and GMC ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMC ratios); within-group CIs were not calculated. IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay.
Time frame: Month 12
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | GMC of Serotype-specific IgG at Month 12 | Serotype 6A (Shared) | 4.27 µg/mL |
| V114 | GMC of Serotype-specific IgG at Month 12 | Serotype 14 (Shared) | 7.91 µg/mL |
| V114 | GMC of Serotype-specific IgG at Month 12 | Serotype 3 (Shared) | 0.39 µg/mL |
| V114 | GMC of Serotype-specific IgG at Month 12 | Serotype 18C (Shared) | 5.99 µg/mL |
| V114 | GMC of Serotype-specific IgG at Month 12 | Serotype 6B (Shared) | 5.13 µg/mL |
| V114 | GMC of Serotype-specific IgG at Month 12 | Serotype 19A (Shared) | 8.19 µg/mL |
| V114 | GMC of Serotype-specific IgG at Month 12 | Serotype 5 (Shared) | 2.59 µg/mL |
| V114 | GMC of Serotype-specific IgG at Month 12 | Serotype 19F (Shared) | 4.67 µg/mL |
| V114 | GMC of Serotype-specific IgG at Month 12 | Serotype 7F (Shared) | 2.95 µg/mL |
| V114 | GMC of Serotype-specific IgG at Month 12 | Serotype 23F (Shared) | 3.57 µg/mL |
| V114 | GMC of Serotype-specific IgG at Month 12 | Serotype 4 (Shared) | 1.00 µg/mL |
| V114 | GMC of Serotype-specific IgG at Month 12 | Serotype 22F (Unique to V114) | 2.07 µg/mL |
| V114 | GMC of Serotype-specific IgG at Month 12 | Serotype 9V (Shared) | 2.85 µg/mL |
| V114 | GMC of Serotype-specific IgG at Month 12 | Serotype 33F (Unique to V114) | 6.24 µg/mL |
| V114 | GMC of Serotype-specific IgG at Month 12 | Serotype 1 (Shared) | 2.73 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Month 12 | Serotype 33F (Unique to V114) | 1.24 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Month 12 | Serotype 1 (Shared) | 3.52 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Month 12 | Serotype 3 (Shared) | 0.28 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Month 12 | Serotype 4 (Shared) | 1.31 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Month 12 | Serotype 5 (Shared) | 2.91 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Month 12 | Serotype 6A (Shared) | 3.13 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Month 12 | Serotype 6B (Shared) | 3.46 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Month 12 | Serotype 7F (Shared) | 3.45 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Month 12 | Serotype 9V (Shared) | 2.75 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Month 12 | Serotype 14 (Shared) | 7.50 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Month 12 | Serotype 18C (Shared) | 4.32 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Month 12 | Serotype 19A (Shared) | 7.22 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Month 12 | Serotype 19F (Shared) | 4.14 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Month 12 | Serotype 23F (Shared) | 2.66 µg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at Month 12 | Serotype 22F (Unique to V114) | 0.33 µg/mL |
Comparison: Serotype 1 (Shared)95% CI: [0.65, 0.92]
Comparison: Serotype 3 (Shared)95% CI: [1.24, 1.63]
Comparison: Serotype 4 (Shared)95% CI: [0.64, 0.91]
Comparison: Serotype 5 (Shared)95% CI: [0.75, 1.05]
Comparison: Serotype 6A (Shared)95% CI: [1.12, 1.67]
Comparison: Serotype 6B (Shared)95% CI: [1.21, 1.81]
Comparison: Serotype 7F (Shared)95% CI: [0.72, 1.02]
Comparison: Serotype 9V (Shared)95% CI: [0.88, 1.23]
Comparison: Serotype 14 (Shared)95% CI: [0.88, 1.26]
Comparison: Serotype 18C (Shared)95% CI: [1.17, 1.64]
Comparison: Serotype 19A (Shared)95% CI: [0.97, 1.33]
Comparison: Serotype 19F (Shared)95% CI: [0.96, 1.32]
Comparison: Serotype 23F (Shared)95% CI: [1.12, 1.62]
Comparison: Serotype 22F (Unique to V114)95% CI: [5.33, 7.21]
Comparison: Serotype 33F (Unique to V114)95% CI: [4.38, 5.73]
Secondary
GMFR in Serotype-specific IgG Day 1 to Day 30
Activity for the serotypes contained in Prevnar 13™ and V114 and (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
Time frame: Day 1 (Baseline) and Day 30
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 18C (Shared) | 22.4 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 1 (Shared) | 13.0 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 3 (Shared) | 6.7 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 4 (Shared) | 10.1 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 5 (Shared) | 5.6 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 6A (Shared) | 30.2 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 6B (Shared) | 28.2 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 7F (Shared) | 13.6 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 9V (Shared) | 11.7 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 14 (Shared) | 6.6 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 19A (Shared) | 11.3 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 19F (Shared) | 14.2 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 23F (Shared) | 17.7 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 22F (Unique to V114) | 14.9 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 33F (Unique to V114) | 11.1 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 19F (Shared) | 11.9 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 9V (Shared) | 10.3 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 1 (Shared) | 14.4 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 22F (Unique to V114) | 0.9 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 3 (Shared) | 3.9 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 14 (Shared) | 6.3 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 4 (Shared) | 12.4 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 18C (Shared) | 13.7 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 5 (Shared) | 5.2 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 23F (Shared) | 11.0 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 6A (Shared) | 20.8 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 19A (Shared) | 9.5 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 6B (Shared) | 17.1 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 33F (Unique to V114) | 0.8 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 7F (Shared) | 14.3 Ratio |
Secondary
GMFR in Serotype-specific IgG Day 1 to Month 12
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
Time frame: Day 1 (Baseline) and Month 12
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 6A (Shared) | 11.1 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 14 (Shared) | 3.9 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 3 (Shared) | 2.6 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 18C (Shared) | 8.0 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 6B (Shared) | 10.3 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 19A (Shared) | 4.9 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 5 (Shared) | 2.7 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 19F (Shared) | 5.2 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 7F (Shared) | 5.5 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 23F (Shared) | 6.6 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 4 (Shared) | 4.3 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 22F (Unique to V114) | 6.0 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 9V (Shared) | 5.6 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 33F (Unique to V114) | 4.7 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 1 (Shared) | 5.2 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 33F (Unique to V114) | 0.9 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 1 (Shared) | 6.6 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 3 (Shared) | 1.8 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 4 (Shared) | 5.5 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 5 (Shared) | 3.0 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 6A (Shared) | 8.1 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 6B (Shared) | 7.2 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 7F (Shared) | 6.4 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 9V (Shared) | 5.4 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 14 (Shared) | 4.1 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 18C (Shared) | 5.6 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 19A (Shared) | 4.3 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 19F (Shared) | 4.9 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 23F (Shared) | 4.9 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 12 | Serotype 22F (Unique to V114) | 1.0 Ratio |
Secondary
GMFR in Serotype-specific IgG Day 1 to Month 13
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
Time frame: Day 1 (Baseline) and Month 13
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 23F (Shared) | 9.1 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 1 (Shared) | 9.9 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 3 (Shared) | 6.9 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 4 (Shared) | 8.6 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 5 (Shared) | 5.9 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 6A (Shared) | 13.1 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 6B (Shared) | 13.7 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 7F (Shared) | 11.1 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 9V (Shared) | 9.8 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 14 (Shared) | 7.4 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 18C (Shared) | 9.8 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 19A (Shared) | 7.9 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 19F (Shared) | 10.7 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 22F (Unique to V114) | 14.2 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 33F (Unique to V114) | 8.1 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 22F (Unique to V114) | 10.0 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 9V (Shared) | 9.2 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 1 (Shared) | 10.5 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 19F (Shared) | 10.0 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 3 (Shared) | 6.7 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 14 (Shared) | 6.9 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 4 (Shared) | 9.5 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 23F (Shared) | 7.6 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 5 (Shared) | 5.9 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 18C (Shared) | 8.2 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 6A (Shared) | 10.8 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 33F (Unique to V114) | 10.1 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 6B (Shared) | 11.9 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 19A (Shared) | 7.0 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 13 | Serotype 7F (Shared) | 11.2 Ratio |
Secondary
GMFR in Serotype-specific IgG Month 12 to Month 13
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
Time frame: Month 12 (Baseline) and Month 13
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 6A (Shared) | 1.2 Ratio |
| V114 | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 14 (Shared) | 1.9 Ratio |
| V114 | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 3 (Shared) | 2.6 Ratio |
| V114 | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 18C (Shared) | 1.2 Ratio |
| V114 | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 6B (Shared) | 1.3 Ratio |
| V114 | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 19A (Shared) | 1.6 Ratio |
| V114 | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 5 (Shared) | 2.3 Ratio |
| V114 | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 19F (Shared) | 2.0 Ratio |
| V114 | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 7F (Shared) | 2.1 Ratio |
| V114 | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 23F (Shared) | 1.4 Ratio |
| V114 | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 4 (Shared) | 2.0 Ratio |
| V114 | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 22F (Unique to V114) | 2.4 Ratio |
| V114 | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 9V (Shared) | 1.8 Ratio |
| V114 | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 33F (Unique to V114) | 1.7 Ratio |
| V114 | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 1 (Shared) | 1.9 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 33F (Unique to V114) | 10.7 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 1 (Shared) | 1.6 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 3 (Shared) | 3.7 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 4 (Shared) | 1.7 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 5 (Shared) | 2.0 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 6A (Shared) | 1.3 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 6B (Shared) | 1.6 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 7F (Shared) | 1.8 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 9V (Shared) | 1.7 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 14 (Shared) | 1.7 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 18C (Shared) | 1.5 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 19A (Shared) | 1.6 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 19F (Shared) | 2.1 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 23F (Shared) | 1.6 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 12 to Month 13 | Serotype 22F (Unique to V114) | 10.0 Ratio |
Secondary
GMFR in Serotype-specific OPA Day 1 to Month 12
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
Time frame: Day 1 (Baseline) and Month 12
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 6A (Shared) | 5.7 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 14 (Shared) | 3.9 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 3 (Shared) | 3.0 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 18C (Shared) | 6.5 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 6B (Shared) | 10.4 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 19A (Shared) | 4.9 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 5 (Shared) | 5.5 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 19F (Shared) | 3.0 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 7F (Shared) | 4.6 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 23F (Shared) | 7.1 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 4 (Shared) | 7.0 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 22F (Unique to V114) | 12.3 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 9V (Shared) | 2.7 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 33F (Unique to V114) | 3.0 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 1 (Shared) | 9.2 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 33F (Unique to V114) | 0.9 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 1 (Shared) | 7.3 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 3 (Shared) | 2.1 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 4 (Shared) | 9.4 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 5 (Shared) | 5.7 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 6A (Shared) | 4.9 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 6B (Shared) | 7.3 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 7F (Shared) | 4.9 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 9V (Shared) | 2.7 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 14 (Shared) | 3.5 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 18C (Shared) | 5.2 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 19A (Shared) | 4.3 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 19F (Shared) | 2.8 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 23F (Shared) | 5.1 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 12 | Serotype 22F (Unique to V114) | 1.3 Ratio |
Secondary
GMFR in Serotype-specific OPA Day 1 to Month 13
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
Time frame: Day 1 (Baseline) and Month 13
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 33F (Unique to V114) | 5.8 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 9V (Shared) | 5.2 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 5 (Shared) | 17.2 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 14 (Shared) | 8.2 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 3 (Shared) | 9.1 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 18C (Shared) | 10.1 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 6A (Shared) | 7.7 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 19A (Shared) | 10.4 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 1 (Shared) | 24.7 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 19F (Shared) | 7.0 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 6B (Shared) | 16.2 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 23F (Shared) | 12.6 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 4 (Shared) | 23.8 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 22F (Unique to V114) | 30.2 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 7F (Shared) | 11.0 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 33F (Unique to V114) | 5.5 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 1 (Shared) | 15.5 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 3 (Shared) | 8.7 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 4 (Shared) | 21.5 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 5 (Shared) | 14.5 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 6A (Shared) | 6.3 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 6B (Shared) | 14.3 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 7F (Shared) | 10.2 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 9V (Shared) | 4.6 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 14 (Shared) | 6.7 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 18C (Shared) | 9.0 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 19A (Shared) | 8.5 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 19F (Shared) | 6.3 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 23F (Shared) | 9.7 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 13 | Serotype 22F (Unique to V114) | 16.2 Ratio |
Secondary
GMFR in Serotype-specific OPA Month 12 to Month 13
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
Time frame: Month 12 (Baseline) and Month 13
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 6A (Shared) | 1.3 Ratio |
| V114 | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 14 (Shared) | 2.1 Ratio |
| V114 | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 3 (Shared) | 3.0 Ratio |
| V114 | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 18C (Shared) | 1.5 Ratio |
| V114 | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 6B (Shared) | 1.5 Ratio |
| V114 | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 19A (Shared) | 2.1 Ratio |
| V114 | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 5 (Shared) | 3.1 Ratio |
| V114 | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 19F (Shared) | 2.3 Ratio |
| V114 | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 7F (Shared) | 2.3 Ratio |
| V114 | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 23F (Shared) | 1.9 Ratio |
| V114 | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 4 (Shared) | 3.3 Ratio |
| V114 | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 22F (Unique to V114) | 2.5 Ratio |
| V114 | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 9V (Shared) | 2.0 Ratio |
| V114 | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 33F (Unique to V114) | 2.0 Ratio |
| V114 | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 1 (Shared) | 2.7 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 33F (Unique to V114) | 6.2 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 1 (Shared) | 2.3 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 3 (Shared) | 4.1 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 4 (Shared) | 2.3 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 5 (Shared) | 2.6 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 6A (Shared) | 1.3 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 6B (Shared) | 1.9 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 7F (Shared) | 2.1 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 9V (Shared) | 1.7 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 14 (Shared) | 1.9 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 18C (Shared) | 1.7 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 19A (Shared) | 2.0 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 19F (Shared) | 2.3 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 23F (Shared) | 1.9 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 12 to Month 13 | Serotype 22F (Unique to V114) | 14.2 Ratio |
Secondary
GMT of Serotype-specific OPA at Day 30
Serotype-specific OPA GMTs (estimated) and GMT ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated. OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay.
Time frame: Day 30
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | GMT of Serotype-specific OPA at Day 30 | Serotype 6A (Shared) | 7352.8 Titers |
| V114 | GMT of Serotype-specific OPA at Day 30 | Serotype 14 (Shared) | 2677.3 Titers |
| V114 | GMT of Serotype-specific OPA at Day 30 | Serotype 3 (Shared) | 245.4 Titers |
| V114 | GMT of Serotype-specific OPA at Day 30 | Serotype 18C (Shared) | 4298.2 Titers |
| V114 | GMT of Serotype-specific OPA at Day 30 | Serotype 6B (Shared) | 5958.1 Titers |
| V114 | GMT of Serotype-specific OPA at Day 30 | Serotype 19A (Shared) | 4856.1 Titers |
| V114 | GMT of Serotype-specific OPA at Day 30 | Serotype 5 (Shared) | 699.0 Titers |
| V114 | GMT of Serotype-specific OPA at Day 30 | Serotype 19F (Shared) | 2418.8 Titers |
| V114 | GMT of Serotype-specific OPA at Day 30 | Serotype 7F (Shared) | 4966.9 Titers |
| V114 | GMT of Serotype-specific OPA at Day 30 | Serotype 23F (Shared) | 2648.7 Titers |
| V114 | GMT of Serotype-specific OPA at Day 30 | Serotype 4 (Shared) | 1280.4 Titers |
| V114 | GMT of Serotype-specific OPA at Day 30 | Serotype 22F (Unique to V114) | 3471.1 Titers |
| V114 | GMT of Serotype-specific OPA at Day 30 | Serotype 9V (Shared) | 2329.9 Titers |
| V114 | GMT of Serotype-specific OPA at Day 30 | Serotype 33F (Unique to V114) | 11392.4 Titers |
| V114 | GMT of Serotype-specific OPA at Day 30 | Serotype 1 (Shared) | 361.6 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Day 30 | Serotype 33F (Unique to V114) | 1244.7 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Day 30 | Serotype 1 (Shared) | 296.2 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Day 30 | Serotype 3 (Shared) | 129.4 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Day 30 | Serotype 4 (Shared) | 1685.9 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Day 30 | Serotype 5 (Shared) | 655.9 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Day 30 | Serotype 6A (Shared) | 6184.2 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Day 30 | Serotype 6B (Shared) | 3631.2 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Day 30 | Serotype 7F (Shared) | 5207.6 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Day 30 | Serotype 9V (Shared) | 2293.0 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Day 30 | Serotype 14 (Shared) | 2458.1 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Day 30 | Serotype 18C (Shared) | 2896.3 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Day 30 | Serotype 19A (Shared) | 3783.0 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Day 30 | Serotype 19F (Shared) | 2203.5 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Day 30 | Serotype 23F (Shared) | 1726.9 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Day 30 | Serotype 22F (Unique to V114) | 99.6 Titers |
Comparison: Serotype 22F (Unique to V114)95% CI: [26.13, 46.5]
Comparison: Serotype 33F (Unique to V114)95% CI: [7.48, 11.2]
Comparison: Serotype 1 (Shared)95% CI: [0.94, 1.58]
Comparison: Serotype 3 (Shared)95% CI: [1.56, 2.3]
Comparison: Serotype 4 (Shared)95% CI: [0.6, 0.97]
Comparison: Serotype 5 (Shared)95% CI: [0.81, 1.4]
Comparison: Serotype 6A (Shared)95% CI: [0.92, 1.53]
Comparison: Serotype 6B (Shared)95% CI: [1.31, 2.06]
Comparison: Serotype 7F (Shared)95% CI: [0.8, 1.14]
Comparison: Serotype 9V (Shared)95% CI: [0.83, 1.24]
Comparison: Serotype 14 (Shared)95% CI: [0.87, 1.37]
Comparison: Serotype 18C (Shared)95% CI: [1.2, 1.84]
Comparison: Serotype 19A (Shared)95% CI: [1.06, 1.55]
Comparison: Serotype 19F (Shared)95% CI: [0.92, 1.32]
Comparison: Serotype 23F (Shared)95% CI: [1.18, 2]
Secondary
GMT of Serotype-specific OPA at Month 12
Serotype-specific OPA GMTs (estimated) and GMT ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated. OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay.
Time frame: Month 12
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | GMT of Serotype-specific OPA at Month 12 | Serotype 4 (Shared) | 477.2 Titers |
| V114 | GMT of Serotype-specific OPA at Month 12 | Serotype 7F (Shared) | 2161.8 Titers |
| V114 | GMT of Serotype-specific OPA at Month 12 | Serotype 19A (Shared) | 1724.3 Titers |
| V114 | GMT of Serotype-specific OPA at Month 12 | Serotype 9V (Shared) | 1006.8 Titers |
| V114 | GMT of Serotype-specific OPA at Month 12 | Serotype 5 (Shared) | 213.4 Titers |
| V114 | GMT of Serotype-specific OPA at Month 12 | Serotype 14 (Shared) | 1543.8 Titers |
| V114 | GMT of Serotype-specific OPA at Month 12 | Serotype 3 (Shared) | 88.3 Titers |
| V114 | GMT of Serotype-specific OPA at Month 12 | Serotype 18C (Shared) | 1520.4 Titers |
| V114 | GMT of Serotype-specific OPA at Month 12 | Serotype 6A (Shared) | 2421.7 Titers |
| V114 | GMT of Serotype-specific OPA at Month 12 | Serotype 23F (Shared) | 984.7 Titers |
| V114 | GMT of Serotype-specific OPA at Month 12 | Serotype 1 (Shared) | 138.2 Titers |
| V114 | GMT of Serotype-specific OPA at Month 12 | Serotype 22F (Unique to V114) | 1267.4 Titers |
| V114 | GMT of Serotype-specific OPA at Month 12 | Serotype 6B (Shared) | 2079.7 Titers |
| V114 | GMT of Serotype-specific OPA at Month 12 | Serotype 33F (Unique to V114) | 4099.0 Titers |
| V114 | GMT of Serotype-specific OPA at Month 12 | Serotype 19F (Shared) | 948.4 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Month 12 | Serotype 33F (Unique to V114) | 1266.6 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Month 12 | Serotype 19F (Shared) | 876.0 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Month 12 | Serotype 19A (Shared) | 1575.3 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Month 12 | Serotype 1 (Shared) | 116.2 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Month 12 | Serotype 3 (Shared) | 56.3 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Month 12 | Serotype 4 (Shared) | 666.5 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Month 12 | Serotype 5 (Shared) | 209.6 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Month 12 | Serotype 6A (Shared) | 2111.3 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Month 12 | Serotype 6B (Shared) | 1453.7 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Month 12 | Serotype 7F (Shared) | 2291.1 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Month 12 | Serotype 9V (Shared) | 1030.5 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Month 12 | Serotype 14 (Shared) | 1395.1 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Month 12 | Serotype 18C (Shared) | 1191.8 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Month 12 | Serotype 23F (Shared) | 720.3 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA at Month 12 | Serotype 22F (Unique to V114) | 99.1 Titers |
Comparison: Serotype 1 (Shared)95% CI: [0.92, 1.53]
Comparison: Serotype 3 (Shared)95% CI: [1.29, 1.9]
Comparison: Serotype 4 (Shared)95% CI: [0.57, 0.9]
Comparison: Serotype 5 (Shared)95% CI: [0.78, 1.33]
Comparison: Serotype 6A (Shared)95% CI: [0.93, 1.41]
Comparison: Serotype 6B (Shared)95% CI: [1.16, 1.77]
Comparison: Serotype 7F (Shared)95% CI: [0.8, 1.11]
Comparison: Serotype 9V (Shared)95% CI: [0.81, 1.18]
Comparison: Serotype 14 (Shared)95% CI: [0.9, 1.36]
Comparison: Serotype 18C (Shared)95% CI: [1.05, 1.55]
Comparison: Serotype 19A (Shared)95% CI: [0.91, 1.31]
Comparison: Serotype 19F (Shared)95% CI: [0.91, 1.29]
Comparison: Serotype 23F (Shared)95% CI: [1.06, 1.76]
Comparison: Serotype 22F (Unique to V114)95% CI: [9.44, 17.34]
Comparison: Serotype 33F (Unique to V114)95% CI: [2.73, 3.84]
Secondary
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
Time frame: Day 1 (Baseline) and Day 30
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 6A (Shared) | 88.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 14 (Shared) | 54.0 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 3 (Shared) | 62.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 18C (Shared) | 83.9 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 6B (Shared) | 85.5 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 19A (Shared) | 71.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 5 (Shared) | 52.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 19F (Shared) | 77.5 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 7F (Shared) | 76.8 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 23F (Shared) | 79.7 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 4 (Shared) | 71.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 22F (Unique to V114) | 76.8 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 9V (Shared) | 73.0 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 33F (Unique to V114) | 71.1 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 1 (Shared) | 74.9 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 33F (Unique to V114) | 0.6 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 1 (Shared) | 80.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 3 (Shared) | 42.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 4 (Shared) | 74.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 5 (Shared) | 49.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 6A (Shared) | 84.3 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 6B (Shared) | 77.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 7F (Shared) | 75.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 9V (Shared) | 70.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 14 (Shared) | 56.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 18C (Shared) | 75.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 19A (Shared) | 69.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 19F (Shared) | 76.3 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 23F (Shared) | 70.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30 | Serotype 22F (Unique to V114) | 0.9 Percentage of Participants |
Secondary
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
Time frame: Day 1 (Baseline) and Month 12
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 6A (Shared) | 75.5 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 14 (Shared) | 42.6 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 3 (Shared) | 27.0 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 18C (Shared) | 70.2 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 6B (Shared) | 73.0 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 19A (Shared) | 53.9 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 5 (Shared) | 30.9 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 19F (Shared) | 56.9 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 7F (Shared) | 59.9 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 23F (Shared) | 59.6 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 4 (Shared) | 47.2 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 22F (Unique to V114) | 58.9 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 9V (Shared) | 60.6 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 33F (Unique to V114) | 52.5 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 1 (Shared) | 56.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 33F (Unique to V114) | 1.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 1 (Shared) | 65.6 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 3 (Shared) | 12.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 4 (Shared) | 57.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 5 (Shared) | 34.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 6A (Shared) | 66.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 6B (Shared) | 62.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 7F (Shared) | 64.9 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 9V (Shared) | 55.3 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 14 (Shared) | 46.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 18C (Shared) | 58.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 19A (Shared) | 50.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 19F (Shared) | 52.3 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 23F (Shared) | 51.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12 | Serotype 22F (Unique to V114) | 1.8 Percentage of Participants |
Secondary
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
Time frame: Day 1 (Baseline) and Month 13
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 6A (Shared) | 81.0 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 14 (Shared) | 68.5 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 3 (Shared) | 72.5 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 18C (Shared) | 78.0 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 6B (Shared) | 81.0 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 19A (Shared) | 70.0 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 5 (Shared) | 59.7 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 19F (Shared) | 77.3 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 7F (Shared) | 81.7 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 23F (Shared) | 72.2 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 4 (Shared) | 76.6 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 22F (Unique to V114) | 80.6 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 9V (Shared) | 76.2 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 33F (Unique to V114) | 75.5 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 1 (Shared) | 79.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 33F (Unique to V114) | 76.6 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 1 (Shared) | 78.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 3 (Shared) | 68.6 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 4 (Shared) | 75.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 5 (Shared) | 59.9 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 6A (Shared) | 77.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 6B (Shared) | 77.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 7F (Shared) | 81.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 9V (Shared) | 73.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 14 (Shared) | 63.9 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 18C (Shared) | 70.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 19A (Shared) | 66.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 19F (Shared) | 74.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 23F (Shared) | 69.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13 | Serotype 22F (Unique to V114) | 71.9 Percentage of Participants |
Secondary
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
Time frame: Month 12 (Baseline) and Month 13
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 4 (Shared) | 14.2 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 7F (Shared) | 17.2 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 1 (Shared) | 15.0 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 9V (Shared) | 10.6 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 5 (Shared) | 20.1 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 14 (Shared) | 14.2 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 33F (Unique to V114) | 10.6 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 18C (Shared) | 0.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 6A (Shared) | 1.1 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 19A (Shared) | 8.0 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 3 (Shared) | 31.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 19F (Shared) | 13.9 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 6B (Shared) | 4.7 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 22F (Shared) | 3.6 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 23F (Unique to V114) | 21.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 22F (Shared) | 10.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 23F (Unique to V114) | 71.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 33F (Unique to V114) | 77.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 3 (Shared) | 43.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 1 (Shared) | 8.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 4 (Shared) | 8.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 5 (Shared) | 15.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 6A (Shared) | 4.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 6B (Shared) | 11.3 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 7F (Shared) | 10.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 9V (Shared) | 9.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 14 (Shared) | 9.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 18C (Shared) | 6.9 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 19A (Shared) | 7.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13 | Serotype 19F (Shared) | 17.9 Percentage of Participants |
Secondary
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
Time frame: Day 1 (Baseline) and Day 30
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 6A (Shared) | 79.2 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 14 (Shared) | 53.0 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 3 (Shared) | 72.1 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 18C (Shared) | 83.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 6B (Shared) | 83.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 19A (Shared) | 70.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 5 (Shared) | 76.8 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 19F (Shared) | 63.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 7F (Shared) | 67.2 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 23F (Shared) | 79.2 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 4 (Shared) | 79.3 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 22F (Unique to V114) | 72.8 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 9V (Shared) | 61.2 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 33F (Unique to V114) | 61.3 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 1 (Shared) | 83.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 33F (Unique to V114) | 3.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 1 (Shared) | 76.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 3 (Shared) | 51.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 4 (Shared) | 84.6 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 5 (Shared) | 79.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 6A (Shared) | 78.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 6B (Shared) | 76.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 7F (Shared) | 65.9 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 9V (Shared) | 56.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 14 (Shared) | 53.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 18C (Shared) | 74.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 19A (Shared) | 69.6 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 19F (Shared) | 56.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 23F (Shared) | 70.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30 | Serotype 22F (Unique to V114) | 16.5 Percentage of Participants |
Secondary
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
Time frame: Day 1 (Baseline) and Month 12
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 6A (Shared) | 61.2 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 14 (Shared) | 41.6 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 3 (Shared) | 39.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 18C (Shared) | 63.3 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 6B (Shared) | 68.8 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 19A (Shared) | 53.2 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 5 (Shared) | 58.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 19F (Shared) | 41.2 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 7F (Shared) | 50.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 23F (Shared) | 62.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 4 (Shared) | 63.0 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 22F (Unique to V114) | 64.0 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 9V (Shared) | 34.6 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 33F (Unique to V114) | 34.5 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 1 (Shared) | 69.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 33F (Unique to V114) | 4.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 1 (Shared) | 61.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 3 (Shared) | 25.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 4 (Shared) | 67.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 5 (Shared) | 57.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 6A (Shared) | 54.3 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 6B (Shared) | 60.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 7F (Shared) | 48.9 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 9V (Shared) | 32.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 14 (Shared) | 42.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 18C (Shared) | 54.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 19A (Shared) | 47.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 19F (Shared) | 35.3 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 23F (Shared) | 53.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12 | Serotype 22F (Unique to V114) | 14.1 Percentage of Participants |
Secondary
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
Time frame: Day 1 (Baseline) and Month 13
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 6A (Shared) | 68.3 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 14 (Shared) | 63.8 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 3 (Shared) | 78.7 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 18C (Shared) | 75.7 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 6B (Shared) | 78.0 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 19A (Shared) | 70.2 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 5 (Shared) | 79.9 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 19F (Shared) | 68.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 7F (Shared) | 72.1 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 23F (Shared) | 74.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 4 (Shared) | 83.7 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 22F (Unique to V114) | 79.5 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 9V (Shared) | 55.8 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 33F (Unique to V114) | 55.8 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 1 (Shared) | 87.9 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 33F (Unique to V114) | 51.6 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 1 (Shared) | 78.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 3 (Shared) | 76.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 4 (Shared) | 84.3 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 5 (Shared) | 80.9 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 6A (Shared) | 64.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 6B (Shared) | 77.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 7F (Shared) | 64.6 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 9V (Shared) | 50.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 14 (Shared) | 58.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 18C (Shared) | 73.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 19A (Shared) | 66.3 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 19F (Shared) | 62.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 23F (Shared) | 66.3 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13 | Serotype 22F (Unique to V114) | 62.6 Percentage of Participants |
Secondary
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
Time frame: Month 12 (Baseline) and Month 13
Population: The analysis population consisted of all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and had sufficient data to perform the analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 6A (Shared) | 9.1 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 14 (Shared) | 21.3 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 3 (Shared) | 39.0 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 18C (Shared) | 10.7 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 6B (Shared) | 8.8 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 19A (Shared) | 20.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 5 (Shared) | 34.9 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 19F (Shared) | 25.3 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 7F (Shared) | 24.7 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 23F (Shared) | 19.0 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 4 (Shared) | 36.3 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 22F (Unique to V114) | 26.8 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 9V (Shared) | 20.1 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 33F (Unique to V114) | 22.1 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 1 (Shared) | 29.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 33F (Unique to V114) | 54.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 1 (Shared) | 25.6 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 3 (Shared) | 49.6 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 4 (Shared) | 22.3 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 5 (Shared) | 29.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 6A (Shared) | 10.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 6B (Shared) | 16.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 7F (Shared) | 21.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 9V (Shared) | 16.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 14 (Shared) | 12.9 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 18C (Shared) | 15.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 19A (Shared) | 17.9 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 19F (Shared) | 27.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 23F (Shared) | 17.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13 | Serotype 22F (Unique to V114) | 62.0 Percentage of Participants |