Pneumococcal Infections
Conditions
Brief summary
This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adults at increased risk for pneumococcal disease and to 2) describe the safety, tolerability, and immunogenicity of PNEUMOVAX™23 when administered 6 months after receipt of either V114 or Prevnar 13™. Increased risk for pneumococcal disease is defined as 1) an underlying medical condition, 2) behavioral habits such as smoking or alcohol use, or 3) living in a community/environment with increased risk of disease transmission.
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 aluminum) 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
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Native American participant enrolled from any of the clinical sites of the Johns Hopkins Center for American Indian Health (CAIH) without any of the pre-specified risk conditions for pneumococcal disease listed below, OR Native American participant enrolled from any of the CAIH sites or participant from a site other than CAIH with ≥1 of the following risk conditions for pneumococcal disease: 1. Diabetes mellitus Type 1 or Type 2 and with hemoglobin A1c (HgA1c) \<10% 2. Chronic liver disease with documented history of compensated cirrhosis (Child-Pugh Score A) 3. Confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD) with spirometric Global Initiative for Chronic Obstructive Lung Disease Stage 1 to 3 4. Confirmed diagnosis of mild or moderate persistent asthma receiving guideline directed therapy 5. Confirmed diagnosis of chronic heart disease (New York Heart Association \[NYHA\] heart failure Class 1 to 3, receiving guideline-directed oral heart failure treatment) due to reduced or preserved ejection fraction or due to non-cyanotic congenital heart disease. 6. Current smoker * 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 last administration of study vaccine.
Exclusion criteria
* History of active hepatitis within the prior 3 months * History of diabetic ketoacidosis, or \>1 episodes of severe, symptomatic hypoglycemia within the prior 3 months * Myocardial infarction, acute coronary syndrome, transient ischemic attack, and ischemic or hemorrhagic stroke within the prior 3 months * History of severe pulmonary hypertension or history of Eisenmenger syndrome * History of invasive pneumococcal disease (IPD) or known history of other culture-positive pneumococcal disease within the prior 3 years * Known hypersensitivity to any vaccine component, pneumococcal conjugate vaccine, or diphtheria toxoid-containing vaccine * Known or suspected impairment of immunological function (including human immunodeficiency virus (HIV) infection or autoimmune disease) * History of malignancy within the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer * History of Stage 4 or 5 Chronic Kidney Disease or nephrotic syndrome * History of alcohol withdrawal or alcohol withdrawal seizure within the prior 12 months * History of coagulation disorder contraindicating intramuscular vaccination * History of hospitalization within the prior 3 months * Planned organ transplantation (heart, liver, lung, kidney, or pancreas) or other planned major surgery during the duration of this study. * Expected survival for less than 1 year according to the investigator's judgment. * 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 within the prior 30 days * Received systemic corticosteroids exceeding physiologic replacement doses within 14 days before study vaccination * Receiving immunosuppressive or immunomodulatory therapy with a biological agent * Received any licensed, non-live vaccine within 14 days before receipt of study vaccine or is scheduled to receive any licensed, non-live vaccine within 30 days following receipt of study vaccine * Received any live vaccine within 30 days before receipt of any study vaccine or is scheduled to receive any live vaccine within 30 days following receipt of any study vaccine * Received a blood transfusion or blood products within the prior 6 months * Receiving chronic home oxygen therapy * Participated in another clinical study of an investigational product within the prior 2 months * Current user of recreational or illicit drugs or history of drug abuse or dependence * Diabetes mellitus with HgA1c ≥10% * Chronic liver disease with Child-Pugh Class B or C cirrhosis * Chronic lung disease with Chronic Obstructive Pulmonary Disease (COPD) GOLD Stage 4 or severe persistent asthma * Chronic heart disease with NYHA heart failure Class 4.
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 intervention, whether or not considered related to the study intervention. Following Vaccination 1 with either 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. Estimated confidence intervals (CIs) are calculated based on the exact binomial method proposed by Clopper and Pearson. |
| Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™ | Up to 14 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 intervention, whether or not considered related to the study intervention. 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. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson. |
| Percentage of Participants With a Vaccine-related Serious Adverse Event Following V114 or Prevnar 13™ | Up to Month 6 (before 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 was determined by the investigator. Following vaccination with V114 or Prevnar 13™, the percentage of serious adverse events of V114 compared with Prevnar 13™ was assessed. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson. |
| Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Day 30 | The geometric mean titer (GMT) of serotype-specific opsonophagocytic activity (OPA) 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 multiplex opsonophagocytic assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 Multiplex 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 | IgG 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 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. 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 Day 1 to Day 30 | Day 1 (Baseline) and Day 30 | IgG 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. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination. |
| Geometric Mean Titer of Serotype-specific OPA at Month 7 | Month 7 | The geometric mean titer (GMT) of serotype-specific OPA 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 multiplex opsonophagocytic assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. |
| Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Month 7 | The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) 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 in Serotype-specific OPA Day 1 to Month 7 | Day 1 (Baseline) and Month 7 | 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. |
| Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23 | Up to 5 days after Vaccination 2 (Month 6) | 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 2 with PNEUMOVAX™23, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan. |
| Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Day 1 (Baseline) and Month 7 | 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. 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 Day 1 to Month 7 | Day 1 (Baseline) and Month 7 | IgG 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. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination. |
| GMFR in Serotype-specific OPA Month 6 to Month 7 | Month 6 (Baseline before Vaccination 2) and Month 7 | 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 the 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 6 to Month 7 | Month 6 (Baseline before Vaccination 2) and Month 7 | IgG 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 Month 6 to Month 7 | Month 6 (Baseline before Vaccination 2) and Month 7 | 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. 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 Month 6 to Month 7 | Month 6 (Baseline before Vaccination 2) and Month 7 | IgG 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. 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 7 | Day 1 (Baseline) and Month 7 | IgG 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 Solicited Systemic Adverse Events Following PNEUMOVAX™23 | Up to 14 days after Vaccination 2 (Month 6) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 2 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. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson. |
| Percentage of Participants With a Vaccine-related Serious Adverse Event Following PNEUMOVAX™23 | From Month 6 (before Vaccination 2) to Month 7 | 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 was determined by the investigator. Following vaccination with PNEUMOVAX™23, the percentage of serious adverse events of V114 compared with Prevnar 13™ was assessed. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson. |
| Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Day 30 | The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) 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. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. |
Countries
Australia, Canada, Chile, New Zealand, Poland, Russia, 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 6 (Vaccination 2). | 1,135 |
| 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 6 (Vaccination 2). | 380 |
| Total | 1,515 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 2 |
| Overall Study | Lost to Follow-up | 59 | 15 |
| Overall Study | Screen Failure | 0 | 1 |
| Overall Study | Withdrawal by Subject | 34 | 12 |
Baseline characteristics
| Characteristic | Total | V114 | Prevnar 13™ |
|---|---|---|---|
| Age, Continuous | 35.8 years STANDARD_DEVIATION 8.9 | 35.9 years STANDARD_DEVIATION 8.9 | 35.8 years STANDARD_DEVIATION 8.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 174 Participants | 135 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1322 Participants | 984 Participants | 338 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 19 Participants | 16 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 593 Participants | 445 Participants | 148 Participants |
| Race (NIH/OMB) Asian | 23 Participants | 15 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 61 Participants | 43 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 20 Participants | 17 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 44 Participants | 33 Participants | 11 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 774 Participants | 582 Participants | 192 Participants |
| Sex: Female, Male Female | 782 Participants | 581 Participants | 201 Participants |
| Sex: Female, Male Male | 733 Participants | 554 Participants | 179 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 | 4 / 1,134 | 2 / 378 | 0 / 1,036 | 0 / 345 |
| other Total, other adverse events | 934 / 1,134 | 298 / 378 | 771 / 1,036 | 258 / 345 |
| serious Total, serious adverse events | 49 / 1,134 | 12 / 378 | 3 / 1,036 | 3 / 345 |
Outcome results
Primary
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™
The geometric mean titer (GMT) of serotype-specific opsonophagocytic activity (OPA) 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 multiplex opsonophagocytic assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Time frame: Day 30
Population: The analysis population included 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 Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 6A (Shared) | 12928.8 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 14 (Shared) | 5228.9 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 3 (Shared) | 199.3 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 18C (Shared) | 5709.0 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 6B (Shared) | 10336.9 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 19A (Shared) | 5369.9 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 5 (Shared) | 564.8 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 19F (Shared) | 3266.3 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 7F (Shared) | 5756.4 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 23F (Shared) | 4853.5 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 4 (Shared) | 1416.0 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 22F (Unique to V114) | 3926.5 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 9V (Shared) | 3355.1 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 33F (Unique to V114) | 11627.8 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 1 (Shared) | 268.6 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 33F (Unique to V114) | 2180.6 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 1 (Shared) | 267.2 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 3 (Shared) | 150.6 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 4 (Shared) | 2576.1 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 5 (Shared) | 731.1 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 6A (Shared) | 11282.4 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 6B (Shared) | 6995.7 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 7F (Shared) | 7588.9 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 9V (Shared) | 3983.7 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 14 (Shared) | 5889.8 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 18C (Shared) | 3063.2 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 19A (Shared) | 5888.0 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 19F (Shared) | 3272.7 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 23F (Shared) | 3887.3 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity Day 30 Following V114 or Prevnar 13™ | Serotype 22F (Unique to V114) | 291.6 Titers |
Primary
Percentage of Participants With a Vaccine-related Serious Adverse Event 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 was determined by the investigator. Following vaccination with V114 or Prevnar 13™, the percentage of serious adverse events of V114 compared with Prevnar 13™ was assessed. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson.
Time frame: Up to Month 6 (before Vaccination 2)
Population: The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 | Percentage of Participants With a Vaccine-related Serious Adverse Event Following V114 or Prevnar 13™ | 0.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With a Vaccine-related Serious Adverse Event Following V114 or Prevnar 13™ | 0.0 Percentage of Participants |
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 intervention, whether or not considered related to the study intervention. Following Vaccination 1 with either 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. Estimated confidence intervals (CIs) are calculated based on the exact binomial method proposed by Clopper and Pearson.
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 and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™ | Injection site redness/erythema | 15.1 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™ | Injection site tenderness/pain | 75.8 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™ | Injection site swelling | 21.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™ | Injection site redness/erythema | 14.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™ | Injection site tenderness/pain | 68.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™ | Injection site swelling | 22.2 Percentage of Participants |
Primary
Percentage of Participants With Solicited Systemic 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 intervention, whether or not considered related to the study intervention. 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. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson.
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 and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™ | Joint pain/arthralgia | 12.7 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™ | Tiredness/fatigue | 34.3 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™ | Headache | 26.5 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™ | Muscle pain/myalgia | 28.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™ | Muscle pain/myalgia | 25.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™ | Joint pain/arthralgia | 11.6 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™ | Headache | 24.9 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™ | Tiredness/fatigue | 36.8 Percentage of Participants |
Secondary
Geometric Mean Concentration of Serotype-specific IgG at Month 7
The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) 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.
Time frame: Month 7
Population: The analysis population included 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 Concentration of Serotype-specific IgG at Month 7 | Serotype 5 (Shared) | 3.45 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 6B (Shared) | 6.79 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 22F (Unique to V114) | 4.85 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 33F (Unique to V114) | 5.98 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 1 (Shared) | 2.91 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 3 (Shared) | 0.66 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 4 (Shared) | 1.33 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 6A (Shared) | 4.25 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 7F (Shared) | 3.46 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 9V (Shared) | 3.18 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 14 (Shared) | 14.28 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 18C (Shared) | 5.50 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 19A (Shared) | 11.26 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 19F (Shared) | 9.07 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 23F (Shared) | 5.42 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 33F (Unique to V114) | 8.66 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 7F (Shared) | 4.07 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 6B (Shared) | 6.04 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 23F (Shared) | 4.96 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 19A (Shared) | 12.04 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 9V (Shared) | 3.61 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 22F (Unique to V114) | 4.76 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 1 (Shared) | 3.42 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 14 (Shared) | 14.59 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 3 (Shared) | 0.68 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 19F (Shared) | 8.81 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 4 (Shared) | 1.77 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 5 (Shared) | 3.92 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 18C (Shared) | 4.24 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Month 7 | Serotype 6A (Shared) | 4.88 µg/mL |
Secondary
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30
The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) 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. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Time frame: Day 30
Population: The analysis population included 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 Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 6A (Shared) | 11.84 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 14 (Shared) | 15.91 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 3 (Shared) | 0.77 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 18C (Shared) | 14.57 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 6B (Shared) | 17.90 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 19A (Shared) | 19.41 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 5 (Shared) | 3.43 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 19F (Shared) | 13.98 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 7F (Shared) | 5.18 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 23F (Shared) | 13.57 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 4 (Shared) | 1.53 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 22F (Unique to V114) | 6.22 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 9V (Shared) | 4.44 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 33F (Unique to V114) | 7.79 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 1 (Shared) | 3.56 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 33F (Unique to V114) | 0.88 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 1 (Shared) | 4.59 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 3 (Shared) | 0.63 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 4 (Shared) | 2.71 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 5 (Shared) | 4.48 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 6A (Shared) | 10.87 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 6B (Shared) | 11.36 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 7F (Shared) | 6.88 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 9V (Shared) | 5.31 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 14 (Shared) | 17.35 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 18C (Shared) | 9.32 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 19A (Shared) | 21.79 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 19F (Shared) | 13.35 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 23F (Shared) | 10.98 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific Immunoglobulin G at Day 30 | Serotype 22F (Unique to V114) | 0.52 µg/mL |
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 Multiplex 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 included 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) | 21.7 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 14 (Shared) | 8.2 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 3 (Shared) | 5.8 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 18C (Shared) | 20.4 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 6B (Shared) | 32.2 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 19A (Shared) | 12.5 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 5 (Shared) | 17.3 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 19F (Shared) | 7.5 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 7F (Shared) | 7.3 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 23F (Shared) | 22.5 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 4 (Shared) | 17.9 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 22F (Unique to V114) | 13.9 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 9V (Shared) | 4.9 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 33F (Unique to V114) | 5.4 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 1 (Shared) | 22.8 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 33F (Unique to V114) | 1.0 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 1 (Shared) | 21.9 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 3 (Shared) | 4.8 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 4 (Shared) | 33.4 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 5 (Shared) | 21.1 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 6A (Shared) | 21.4 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 6B (Shared) | 25.0 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 7F (Shared) | 10.0 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 9V (Shared) | 5.7 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 14 (Shared) | 8.7 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 18C (Shared) | 11.7 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 19A (Shared) | 13.6 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 19F (Shared) | 7.4 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 23F (Shared) | 17.8 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 22F (Unique to V114) | 1.3 Ratio |
Secondary
Geometric Mean Titer of Serotype-specific OPA at Month 7
The geometric mean titer (GMT) of serotype-specific OPA 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 multiplex opsonophagocytic assay. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Time frame: Month 7
Population: The analysis population included 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 Titer of Serotype-specific OPA at Month 7 | Serotype 5 (Shared) | 595.1 Titers |
| V114 | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 9V (Shared) | 3133.1 Titers |
| V114 | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 1 (Shared) | 266.6 Titers |
| V114 | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 14 (Shared) | 5644.9 Titers |
| V114 | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 6A (Shared) | 5810.3 Titers |
| V114 | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 18C (Shared) | 3260.6 Titers |
| V114 | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 4 (Shared) | 1734.5 Titers |
| V114 | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 19A (Shared) | 4336.2 Titers |
| V114 | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 6B (Shared) | 5215.2 Titers |
| V114 | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 19F (Shared) | 3198.6 Titers |
| V114 | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 3 (Shared) | 211.0 Titers |
| V114 | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 23F (Shared) | 3057.3 Titers |
| V114 | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 7F (Shared) | 6070.5 Titers |
| V114 | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 22F (Unique to V114) | 3624.0 Titers |
| V114 | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 33F (Unique to V114) | 11356.6 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 7F (Shared) | 6223.9 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 33F (Unique to V114) | 16053.2 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 1 (Shared) | 214.4 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 3 (Shared) | 208.0 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 4 (Shared) | 1980.6 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 5 (Shared) | 626.7 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 6A (Shared) | 5739.9 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 6B (Shared) | 4412.4 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 22F (Unique to V114) | 4060.2 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 9V (Shared) | 3364.1 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 14 (Shared) | 5317.6 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 18C (Shared) | 2294.4 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 19A (Shared) | 4286.4 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 19F (Shared) | 3085.4 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific OPA at Month 7 | Serotype 23F (Shared) | 2896.0 Titers |
Secondary
GMFR in Serotype-specific IgG Day 1 to Day 30
IgG 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 Day 30
Population: The analysis population included 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 6A (Shared) | 35.5 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 14 (Shared) | 11.3 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 3 (Shared) | 4.1 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 18C (Shared) | 30.5 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 6B (Shared) | 40.5 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 19A (Shared) | 11.1 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 5 (Shared) | 4.3 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 19F (Shared) | 14.4 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 7F (Shared) | 12.2 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 23F (Shared) | 26.5 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 4 (Shared) | 8.0 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 22F (Unique to V114) | 11.4 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 9V (Shared) | 10.6 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 33F (Unique to V114) | 8.3 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 1 (Shared) | 12.2 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 33F (Unique to V114) | 1.0 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 1 (Shared) | 15.7 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 3 (Shared) | 3.6 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 4 (Shared) | 16.2 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 6A (Shared) | 31.3 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 6B (Shared) | 28.0 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 7F (Shared) | 16.9 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 9V (Shared) | 12.8 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 14 (Shared) | 11.5 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 18C (Shared) | 20.0 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 19A (Shared) | 14.0 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 19F (Shared) | 15.3 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 23F (Shared) | 22.0 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Day 30 | Serotype 22F (Unique to V114) | 1.0 Ratio |
Secondary
GMFR in Serotype-specific IgG Day 1 to Month 7
IgG 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 7
Population: The analysis population included 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 7 | Serotype 5 (Shared) | 4.3 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 9V (Shared) | 7.6 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 19A (Shared) | 6.4 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 14 (Shared) | 10.3 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 6A (Shared) | 12.3 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 18C (Shared) | 11.5 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 3 (Shared) | 3.5 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 19F (Shared) | 9.0 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 6B (Shared) | 15.3 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 23F (Shared) | 10.8 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 4 (Shared) | 7.1 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 22F (Unique to V114) | 8.9 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 7F (Shared) | 8.7 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 33F (Unique to V114) | 6.4 Ratio |
| V114 | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 1 (Shared) | 10.1 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 33F (Unique to V114) | 9.6 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 1 (Shared) | 11.4 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 3 (Shared) | 3.8 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 19A (Shared) | 7.5 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 4 (Shared) | 10.7 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 5 (Shared) | 4.6 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 6A (Shared) | 13.9 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 6B (Shared) | 14.9 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 7F (Shared) | 10.1 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 9V (Shared) | 8.5 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 14 (Shared) | 10.0 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 18C (Shared) | 9.3 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 19F (Shared) | 9.8 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 23F (Shared) | 10.3 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Day 1 to Month 7 | Serotype 22F (Unique to V114) | 8.9 Ratio |
Secondary
GMFR in Serotype-specific IgG Month 6 to Month 7
IgG 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: Month 6 (Baseline before Vaccination 2) and Month 7
Population: The analysis population included 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 6 to Month 7 | Serotype 4 (Shared) | 2.0 Ratio |
| V114 | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 14 (Shared) | 1.7 Ratio |
| V114 | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 6A (Shared) | 1.0 Ratio |
| V114 | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 18C (Shared) | 1.1 Ratio |
| V114 | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 23F (Shared) | 1.1 Ratio |
| V114 | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 3 (Shared) | 1.7 Ratio |
| V114 | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 19A (Shared) | 1.4 Ratio |
| V114 | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 6B (Shared) | 1.1 Ratio |
| V114 | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 19F (Shared) | 1.6 Ratio |
| V114 | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 1 (Shared) | 2.1 Ratio |
| V114 | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 7F (Shared) | 1.7 Ratio |
| V114 | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 22F (Unique to V114) | 1.8 Ratio |
| V114 | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 5 (Shared) | 1.9 Ratio |
| V114 | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 33F (Unique to V114) | 1.6 Ratio |
| V114 | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 9V (Shared) | 1.5 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 33F (Unique to V114) | 9.9 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 1 (Shared) | 1.5 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 4 (Shared) | 1.6 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 5 (Shared) | 1.5 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 6A (Shared) | 1.0 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 6B (Shared) | 1.2 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 7F (Shared) | 1.4 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 9V (Shared) | 1.4 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 14 (Shared) | 1.4 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 18C (Shared) | 1.1 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 19A (Shared) | 1.4 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 19F (Shared) | 1.6 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 23F (Shared) | 1.2 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 22F (Unique to V114) | 8.8 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific IgG Month 6 to Month 7 | Serotype 3 (Shared) | 2.0 Ratio |
Secondary
GMFR in Serotype-specific OPA Day 1 to Month 7
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 7
Population: The analysis population included 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 7 | Serotype 1 (Shared) | 22.6 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 3 (Shared) | 6.1 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 4 (Shared) | 21.6 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 6B (Shared) | 16.6 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 7F (Shared) | 7.7 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 33F (Unique to V114) | 5.1 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 6A (Shared) | 9.6 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 5 (Shared) | 17.8 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 9V (Shared) | 4.5 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 14 (Shared) | 9.2 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 18C (Shared) | 11.1 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 19A (Shared) | 9.6 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 19F (Shared) | 6.9 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 23F (Shared) | 14.0 Ratio |
| V114 | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 22F (Unique to V114) | 12.1 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 33F (Unique to V114) | 6.6 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 1 (Shared) | 17.4 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 9V (Shared) | 4.9 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 3 (Shared) | 6.4 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 19F (Shared) | 7.1 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 6A (Shared) | 11.0 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 14 (Shared) | 8.0 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 22F (Unique to V114) | 16.6 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 18C (Shared) | 9.1 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 23F (Shared) | 12.6 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 4 (Shared) | 25.6 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 19A (Shared) | 9.7 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 5 (Shared) | 18.3 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 6B (Shared) | 15.7 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Day 1 to Month 7 | Serotype 7F (Shared) | 8.2 Ratio |
Secondary
GMFR in Serotype-specific OPA Month 6 to Month 7
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 the Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
Time frame: Month 6 (Baseline before Vaccination 2) and Month 7
Population: The analysis population included 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 6 to Month 7 | Serotype 3 (Shared) | 2.0 Ratio |
| V114 | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 7F (Shared) | 1.9 Ratio |
| V114 | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 14 (Shared) | 2.0 Ratio |
| V114 | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 5 (Shared) | 2.7 Ratio |
| V114 | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 18C (Shared) | 1.3 Ratio |
| V114 | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 19A (Shared) | 1.7 Ratio |
| V114 | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 9V (Shared) | 1.6 Ratio |
| V114 | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 19F (Shared) | 1.9 Ratio |
| V114 | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 6A (Shared) | 1.0 Ratio |
| V114 | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 23F (Shared) | 1.3 Ratio |
| V114 | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 4 (Shared) | 2.7 Ratio |
| V114 | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 22F (Unique to V114) | 1.8 Ratio |
| V114 | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 6B (Shared) | 1.1 Ratio |
| V114 | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 33F (Unique to V114) | 1.6 Ratio |
| V114 | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 1 (Shared) | 3.2 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 33F (Unique to V114) | 6.5 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 1 (Shared) | 2.0 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 7F (Shared) | 1.4 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 9V (Shared) | 1.5 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 18C (Shared) | 1.6 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 3 (Shared) | 2.4 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 4 (Shared) | 1.7 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 5 (Shared) | 2.1 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 6A (Shared) | 1.1 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 6B (Shared) | 1.2 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 14 (Shared) | 1.5 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 19A (Shared) | 1.5 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 19F (Shared) | 1.6 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 23F (Shared) | 1.4 Ratio |
| Prevnar 13™ | GMFR in Serotype-specific OPA Month 6 to Month 7 | Serotype 22F (Unique to V114) | 9.6 Ratio |
Secondary
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30
IgG 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. 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 included 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 Day 1 to Day 30 | Serotype 6A (Shared) | 93.3 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 14 (Shared) | 70.8 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 3 (Shared) | 44.8 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 18C (Shared) | 91.1 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 6B (Shared) | 93.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 19A (Shared) | 75.3 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 5 (Shared) | 44.1 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 19F (Shared) | 80.0 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 7F (Shared) | 79.3 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 23F (Shared) | 89.2 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 4 (Shared) | 70.1 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 22F (Unique to V114) | 73.1 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 9V (Shared) | 76.5 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 33F (Unique to V114) | 70.0 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 1 (Shared) | 81.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 33F (Unique to V114) | 0.3 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 1 (Shared) | 86.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 3 (Shared) | 41.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 4 (Shared) | 86.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 5 (Shared) | 50.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 6A (Shared) | 88.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 6B (Shared) | 90.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 7F (Shared) | 86.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 9V (Shared) | 84.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 14 (Shared) | 68.6 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 18C (Shared) | 87.3 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 19A (Shared) | 82.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 19F (Shared) | 80.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 23F (Shared) | 87.6 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Day 30 | Serotype 22F (Unique to V114) | 1.5 Percentage of Participants |
Secondary
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7
IgG 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. 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 7
Population: The analysis population included 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 Day 1 to Month 7 | Serotype 9V (Shared) | 71.8 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 1 (Shared) | 81.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 14 (Shared) | 76.7 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 6A (Shared) | 81.6 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 18C (Shared) | 82.7 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 19A (Shared) | 65.8 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 4 (Shared) | 71.2 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 19F (Shared) | 74.5 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 6B (Shared) | 86.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 23F (Shared) | 77.8 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 3 (Shared) | 40.7 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 22F (Unique to V114) | 68.8 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 7F (Shared) | 77.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 33F (Unique to V114) | 68.2 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 5 (Shared) | 48.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 33F (Unique to V114) | 75.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 1 (Shared) | 83.6 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 3 (Shared) | 46.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 4 (Shared) | 82.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 5 (Shared) | 51.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 6A (Shared) | 81.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 6B (Shared) | 85.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 7F (Shared) | 84.3 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 9V (Shared) | 77.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 14 (Shared) | 70.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 19A (Shared) | 74.6 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 19F (Shared) | 78.9 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 23F (Shared) | 78.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 22F (Unique to V114) | 65.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Day 1 to Month 7 | Serotype 18C (Shared) | 80.4 Percentage of Participants |
Secondary
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7
IgG 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. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
Time frame: Month 6 (Baseline before Vaccination 2) and Month 7
Population: The analysis population included 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 Month 6 to Month 7 | Serotype 4 (Shared) | 15.2 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 23F (Shared) | 0.5 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 9V (Shared) | 6.3 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 22F (Unique to V114) | 10.2 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 6B (Shared) | 0.7 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 33F (Unique to V114) | 7.5 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 18C (Shared) | 0.6 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 1 (Shared) | 16.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 14 (Shared) | 9.8 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 3 (Shared) | 6.3 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 19A (Shared) | 3.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 5 (Shared) | 12.1 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 7F (Shared) | 8.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 6A (Shared) | 0.6 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 19F (Shared) | 8.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 6A (Shared) | 1.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 14 (Shared) | 3.9 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 6B (Shared) | 2.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 7F (Shared) | 4.3 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 9V (Shared) | 3.9 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 18C (Shared) | 0.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 19A (Shared) | 4.3 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 19F (Shared) | 6.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 23F (Shared) | 1.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 22F (Unique to V114) | 64.9 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 33F (Unique to V114) | 75.9 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 1 (Shared) | 8.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 4 (Shared) | 7.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 5 (Shared) | 5.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Month 6 to Month 7 | Serotype 3 (Shared) | 13.8 Percentage of Participants |
Secondary
Percentage of Participants With ≥4-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. 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 included 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 Day 1 to Day 30 | Serotype 3 (Shared) | 62.2 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 6B (Shared) | 84.7 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 22F (Unique to V114) | 58.9 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 7F (Shared) | 56.8 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 4 (Shared) | 79.0 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 9V (Shared) | 51.5 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 1 (Shared) | 83.9 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 14 (Shared) | 59.8 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 5 (Shared) | 83.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 18C (Shared) | 84.5 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 33F (Unique to V114) | 52.9 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 19A (Shared) | 72.1 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 6A (Shared) | 87.5 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 19F (Shared) | 64.3 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 23F (Shared) | 78.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 19F (Shared) | 65.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 23F (Shared) | 77.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 22F (Unique to V114) | 15.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 33F (Unique to V114) | 3.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 1 (Shared) | 81.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 3 (Shared) | 56.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 4 (Shared) | 87.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 5 (Shared) | 84.9 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 6A (Shared) | 85.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 6B (Shared) | 83.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 7F (Shared) | 64.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 9V (Shared) | 55.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 14 (Shared) | 60.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 18C (Shared) | 75.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Day 30 | Serotype 19A (Shared) | 75.2 Percentage of Participants |
Secondary
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7
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. 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 7
Population: The analysis population included 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 Day 1 to Month 7 | Serotype 4 (Shared) | 84.3 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 9V (Shared) | 50.5 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 5 (Shared) | 86.8 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 14 (Shared) | 64.9 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 19A (Shared) | 68.2 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 18C (Shared) | 77.5 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 6A (Shared) | 73.5 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 19F (Shared) | 61.0 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 3 (Shared) | 66.5 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 23F (Shared) | 73.5 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 6B (Shared) | 75.8 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 22F (Unique to V114) | 59.0 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 1 (Shared) | 87.7 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 33F (Unique to V114) | 53.3 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 7F (Shared) | 59.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 33F (Unique to V114) | 60.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 18C (Shared) | 76.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 1 (Shared) | 83.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 3 (Shared) | 66.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 5 (Shared) | 87.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 6A (Shared) | 80.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 6B (Shared) | 74.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 7F (Shared) | 60.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 9V (Shared) | 52.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 14 (Shared) | 58.9 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 19A (Shared) | 70.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 19F (Shared) | 62.9 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 23F (Shared) | 71.9 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 22F (Unique to V114) | 65.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Day 1 to Month 7 | Serotype 4 (Shared) | 86.4 Percentage of Participants |
Secondary
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7
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. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
Time frame: Month 6 (Baseline before Vaccination 2) and Month 7
Population: The analysis population included 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 Month 6 to Month 7 | Serotype 9V (Shared) | 11.9 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 19A (Shared) | 15.9 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 14 (Shared) | 17.8 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 4 (Shared) | 30.8 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 18C (Shared) | 5.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 5 (Shared) | 32.5 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 1 (Shared) | 40.2 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 19F (Shared) | 17.7 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 6A (Shared) | 3.9 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 23F (Shared) | 9.2 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 7F (Shared) | 14.6 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 22F (Unique to V114) | 16.7 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 6B (Shared) | 4.6 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 33F (Unique to V114) | 15.8 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 3 (Shared) | 19.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 33F (Unique to V114) | 62.6 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 7F (Shared) | 7.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 1 (Shared) | 21.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 3 (Shared) | 25.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 5 (Shared) | 23.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 6A (Shared) | 5.9 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 6B (Shared) | 6.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 9V (Shared) | 10.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 14 (Shared) | 8.6 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 18C (Shared) | 14.3 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 19A (Shared) | 12.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 19F (Shared) | 12.9 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 23F (Shared) | 11.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 22F (Unique to V114) | 52.6 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Month 6 to Month 7 | Serotype 4 (Shared) | 14.9 Percentage of Participants |
Secondary
Percentage of Participants With a Vaccine-related Serious Adverse Event 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 was determined by the investigator. Following vaccination with PNEUMOVAX™23, the percentage of serious adverse events of V114 compared with Prevnar 13™ was assessed. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson.
Time frame: From Month 6 (before Vaccination 2) to Month 7
Population: The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 | Percentage of Participants With a Vaccine-related Serious Adverse Event Following PNEUMOVAX™23 | 0.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With a Vaccine-related Serious Adverse Event Following PNEUMOVAX™23 | 0.3 Percentage of Participants |
Secondary
Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23
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 2 with PNEUMOVAX™23, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson and are provided in accordance with the statistical analysis plan.
Time frame: Up to 5 days after Vaccination 2 (Month 6)
Population: All randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23 | Injection site redness/erythema | 22.6 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23 | Injection site tenderness/pain | 68.8 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23 | Injection site swelling | 29.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23 | Injection site redness/erythema | 25.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23 | Injection site tenderness/pain | 67.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23 | Injection site swelling | 32.2 Percentage of Participants |
Secondary
Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 2 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. Estimated CIs are calculated based on the exact binomial method proposed by Clopper and Pearson.
Time frame: Up to 14 days after Vaccination 2 (Month 6)
Population: The analysis population included all randomized participants who received the relevant study vaccination for the timepoint of interest and were included in the intervention group according to the intervention they received. One participant in the Prevnar 13™ group incorrectly received V114 and was included in the V114 group for safety analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23 | Joint pain/arthralgia | 12.0 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23 | Tiredness/fatigue | 30.1 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23 | Headache | 21.2 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23 | Muscle pain/myalgia | 24.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23 | Muscle pain/myalgia | 25.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23 | Joint pain/arthralgia | 11.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23 | Headache | 21.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23 | Tiredness/fatigue | 30.7 Percentage of Participants |