Pneumococcal Infections, Pneumonia, Pneumococcal
Conditions
Brief summary
The primary objectives are to evaluate the safety and tolerability of V114 and to compare the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) across 3 different lots of V114. The primary hypothesis is that all 3 lots of V114 are equivalent as measured by the serotype-specific OPA GMTs for 15 serotypes in V114 at 30 days postvaccination.
Interventions
DRUGV114
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in each 0.5 mL dose.
DRUGPrevnar 13™
13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F in each 0.5. mL dose.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participant has good health in the opinion of the investigator. Any underlying chronic condition must be documented to be in stable condition according to the investigator's judgment. * Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Female participant is eligible to participate if she is not pregnant, not breastfeeding, and is not a woman of childbearing potential (WOCBP) OR a WOCBP who agrees to use agreed upon contraception during the treatment period and for at least 6 weeks after the last dose of study intervention.
Exclusion criteria
* History of invasive pneumococcal disease (IPD) (positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site) or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1). * Known hypersensitivity to any component of pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid-containing vaccine. * Known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease. * Coagulation disorder contraindicating intramuscular vaccinations. * Recent febrile illness (defined as oral or tympanic temperature ≥100.4°F \[≥38.0°C\] or axillary or temporal temperature ≥99.4°F \[≥37.4°C\]) or received antibiotic therapy for any acute illness occurring within 72 hours before receipt of study vaccine. * History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. * A WOCBP who has a positive urine or serum pregnancy test before the first vaccination at Visit 1 (Day 1). * Has received any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside of the protocol. * Has received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention at least 30 days before study entry. * Has received systemic corticosteroids exceeding physiologic replacement doses (approximately 5 mg/day prednisone equivalent) within 14 days before vaccination. (Note: Topical, ophthalmic, intra-articular or soft-tissue \[e.g., bursa, tendon steroid injections\], and inhaled/nebulized steroids are permitted). * Is receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease. * Has received any non-live vaccine within the 14 days before receipt of any study vaccine or is scheduled to receive any non-live vaccine within 30 days following receipt of any study vaccine. (Exception: Inactivated influenza vaccine may be administered but must be given at least 7 days before receipt of any study vaccine or at least 15 days after receipt of any study vaccine.) * Has 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. If this exclusion criterion is met, then Day 1 Visit may be rescheduled for a time when criterion is not met. * Has received a blood transfusion or blood products, including immunoglobulin, within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion. * Currently participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study. * In the opinion of the investigator, has a history of clinically relevant drug or alcohol use that would interfere with participation in protocol-specified activities. * History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might expose the participant to risk by participating in the study, confound the results of the study, or interfere with the participant's participation for the full duration of the study. * Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Day 30 | Opsonization of pneumococci for phagocytosis is an important mechanism by which antibodies to polysaccharides protect against disease in vivo. Sera from participants was used to measure geometric mean titer (GMT) of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the Multiplexed Opsonophagocytic Assay (MOPA). Per the statistical analysis plan, within-group CIs were not calculated. 95% CIs were calculated for the GMT ratios between pairs of V114 lots by a constrained longitudinal data analysis (cLDA) model; and the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots. |
| Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With Separate V114 Lots | Up to Day 5 | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of redness/erythema, swelling, and tenderness/pain. The 95% confidence interval (CI) were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with solicited injection-site AEs was assessed. Per the statistical analysis plan, the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots. |
| Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Up to Day 5 | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of redness/erythema, swelling, and tenderness/pain. Per the statistical analysis plan, within-group CIs were not calculated. |
| Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With Separate V114 Lots | Up to Day 14 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consisted of muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with solicited systemic AEs was assessed. Per the statistical analysis plan, the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots. |
| Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Up to Day 14 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consisted of muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. Per the statistical analysis plan, within-group CIs were not calculated. |
| Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination With Separate V114 Lots | Up to Month 6 | A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. Relatedness of an SAE to the study vaccine is determined by the investigator. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with SAEs was assessed. Per the statistical analysis plan, the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots. |
| Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Up to Month 6 | A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. Relatedness of an SAE to the study vaccine is determined by the investigator. Per the statistical analysis plan, within-group CIs were not calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Day 30 | The GMC of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by ECL. Per the statistical analysis plan, within-group CIs were not calculated, |
| Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Day 1 (Baseline) and Day 30 | Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the MOPA which reads the reciprocal of the highest dilution that gives ≥50% bacterial killing. The Geometric Mean Fold Rise (GMFR) is the geometric mean of the ratio Day 30/Day 1 OPA responses. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed. |
| GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Day 1 (Baseline) and Day 30 | The geometric mean concentration (GMC) of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by ECL. The GMFR is the geometric mean of the ratio Day 30/Day 1 IgG concentration. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed. |
| Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Day 1 (Baseline) and Day 30 | Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, with the MOPA which reads the reciprocal of the highest dilution (1/dil) that gives ≥50% bacterial killing. Percentage of participants with a ≥ 4-fold change from Day 1 (baseline) to Day 30 (Day 30/Day 1) are presented. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed. |
| Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Day 1 (Baseline) and Day 30 | The geometric mean concentration of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by ECL. Percentage of participants with a ≥ 4-fold change from Day 1 (baseline) to Day 30 (Day 30/ Day 1) are presented. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed. |
| Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Day 30 | The geometric mean concentration (GMC) of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by multiplex electrochemiluminescence (ECL) using the pneumococcal electrochemiluminescence (PnECL) v2.0 assay. Per the statistical analysis plan, within-group CIs were not calculated; and the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots. |
Countries
Australia, Chile, Denmark, Finland, United Kingdom, United States
Participant flow
Recruitment details
Healthy males or females ≥50 years of age without a history of invasive pneumococcal disease or prior administration of any pneumococcal vaccine were enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| V114 Lot 1 Single IM dose at 0.5 mL of V114 Lot 1 pneumococcal conjugate vaccine at Visit 1 (Day 1) | 702 |
| V114 Lot 2 Single IM dose at 0.5 mL of V114 Lot 2 pneumococcal conjugate vaccine at Visit 1 (Day 1) | 704 |
| V114 Lot 3 Single IM dose at 0.5 mL of V114 Lot 3 pneumococcal conjugate vaccine at Visit 1 (Day 1) | 701 |
| Prevnar13™ Single IM dose at 0.5 mL of Prevnar 13™ at Visit 1 (Day 1) | 233 |
| Total | 2,340 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 1 | 2 | 0 | 0 |
| Overall Study | Lost to Follow-up | 5 | 6 | 8 | 2 |
| Overall Study | Protocol Violation | 2 | 0 | 0 | 1 |
| Overall Study | Unable to phone | 7 | 6 | 7 | 2 |
| Overall Study | Withdrawal by Subject | 4 | 1 | 3 | 1 |
Baseline characteristics
| Characteristic | V114 Lot 1 | V114 Lot 2 | V114 Lot 3 | Prevnar13™ | Total |
|---|---|---|---|---|---|
| Age, Continuous | 64.4 Years STANDARD_DEVIATION 7.5 | 64.4 Years STANDARD_DEVIATION 7.8 | 64.3 Years STANDARD_DEVIATION 7.4 | 64.2 Years STANDARD_DEVIATION 8 | 64.4 Years STANDARD_DEVIATION 7.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 131 Participants | 154 Participants | 138 Participants | 41 Participants | 464 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 560 Participants | 540 Participants | 558 Participants | 190 Participants | 1848 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 11 Participants | 10 Participants | 5 Participants | 2 Participants | 28 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 4 Participants | 0 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 18 Participants | 34 Participants | 36 Participants | 10 Participants | 98 Participants |
| Race (NIH/OMB) Black or African American | 35 Participants | 41 Participants | 34 Participants | 20 Participants | 130 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 4 Participants | 3 Participants | 0 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 644 Participants | 621 Participants | 628 Participants | 203 Participants | 2096 Participants |
| Sex: Female, Male Female | 387 Participants | 422 Participants | 404 Participants | 133 Participants | 1346 Participants |
| Sex: Female, Male Male | 315 Participants | 282 Participants | 297 Participants | 100 Participants | 994 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 | 1 / 702 | 2 / 704 | 0 / 701 | 0 / 233 |
| other Total, other adverse events | 548 / 699 | 534 / 704 | 535 / 700 | 151 / 230 |
| serious Total, serious adverse events | 12 / 699 | 19 / 704 | 7 / 700 | 5 / 230 |
Outcome results
Primary
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots
Opsonization of pneumococci for phagocytosis is an important mechanism by which antibodies to polysaccharides protect against disease in vivo. Sera from participants was used to measure geometric mean titer (GMT) of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the Multiplexed Opsonophagocytic Assay (MOPA). Per the statistical analysis plan, within-group CIs were not calculated. 95% CIs were calculated for the GMT ratios between pairs of V114 lots by a constrained longitudinal data analysis (cLDA) model; and the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.
Time frame: Day 30
Population: All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 Lot 1 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 3 | 198.3 1/dil |
| V114 Lot 1 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 18C | 3880.8 1/dil |
| V114 Lot 1 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 6B | 5160.6 1/dil |
| V114 Lot 1 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 14 | 2364.8 1/dil |
| V114 Lot 1 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 7F | 3757.7 1/dil |
| V114 Lot 1 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 1 | 248.5 1/dil |
| V114 Lot 1 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 9V | 1708.4 1/dil |
| V114 Lot 1 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 23F | 2222.9 1/dil |
| V114 Lot 1 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 4 | 1073.1 1/dil |
| V114 Lot 1 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 33F | 7758.1 1/dil |
| V114 Lot 1 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 19F | 1866.4 1/dil |
| V114 Lot 1 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 5 | 389.8 1/dil |
| V114 Lot 1 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 22F | 2617.4 1/dil |
| V114 Lot 1 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 19A | 3384.7 1/dil |
| V114 Lot 1 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 6A | 5845.0 1/dil |
| V114 Lot 2 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 19F | 2017.8 1/dil |
| V114 Lot 2 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 1 | 251.6 1/dil |
| V114 Lot 2 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 3 | 232.2 1/dil |
| V114 Lot 2 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 4 | 1303.7 1/dil |
| V114 Lot 2 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 5 | 461.6 1/dil |
| V114 Lot 2 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 6A | 6077.6 1/dil |
| V114 Lot 2 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 7F | 4590.5 1/dil |
| V114 Lot 2 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 9V | 1690.6 1/dil |
| V114 Lot 2 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 14 | 2509.6 1/dil |
| V114 Lot 2 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 18C | 3522.4 1/dil |
| V114 Lot 2 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 19A | 3774.8 1/dil |
| V114 Lot 2 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 6B | 5362.7 1/dil |
| V114 Lot 2 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 23F | 2417.8 1/dil |
| V114 Lot 2 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 22F | 2761.6 1/dil |
| V114 Lot 2 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 33F | 7736.9 1/dil |
| V114 Lot 3 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 5 | 391.3 1/dil |
| V114 Lot 3 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 33F | 7365.6 1/dil |
| V114 Lot 3 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 19A | 3498.5 1/dil |
| V114 Lot 3 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 4 | 1074.4 1/dil |
| V114 Lot 3 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 22F | 2676.0 1/dil |
| V114 Lot 3 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 19F | 1993.2 1/dil |
| V114 Lot 3 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 3 | 214.4 1/dil |
| V114 Lot 3 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 7F | 4202.0 1/dil |
| V114 Lot 3 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 14 | 2050.6 1/dil |
| V114 Lot 3 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 9V | 1749.9 1/dil |
| V114 Lot 3 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 6B | 5109.5 1/dil |
| V114 Lot 3 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 23F | 2133.0 1/dil |
| V114 Lot 3 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 6A | 6123.8 1/dil |
| V114 Lot 3 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 1 | 239.4 1/dil |
| V114 Lot 3 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Following Vaccination With Separate V114 Lots | Serotype 18C | 3381.0 1/dil |
Comparison: Serotype 1: GMT Ratio V114 Lot 1 / V114 Lot 2p-value: <0.00195% CI: [0.83, 1.18]cLDA model
Comparison: Serotype 1: GMT Ratio V114 Lot 1 / V114 Lot 3p-value: <0.00195% CI: [0.87, 1.24]cLDA model
Comparison: Serotype 1: GMT Ratio V114 Lot 2 / V114 Lot 3p-value: <0.00195% CI: [0.88, 1.25]cLDA model
Comparison: Serotype 3: GMT Ratio V114 Lot 1 / V114 Lot 2p-value: <0.00195% CI: [0.75, 0.97]cLDA model
Comparison: Serotype 3: GMT Ratio V114 Lot 1 / V114 Lot 3p-value: <0.00195% CI: [0.81, 1.05]cLDA model
Comparison: Serotype 3: GMT Ratio V114 Lot 2 / V114 Lot 3p-value: <0.00195% CI: [0.95, 1.23]cLDA model
Comparison: Serotype 4: GMT Ratio V114 Lot 1 / V114 Lot 2p-value: <0.00195% CI: [0.7, 0.97]cLDA model
Comparison: Serotype 4: GMT Ratio V114 Lot 1 / V114 Lot 3p-value: <0.00195% CI: [0.85, 1.18]cLDA model
Comparison: Serotype 4: GMT Ratio V114 Lot 2 / V114 Lot 3p-value: <0.00195% CI: [1.03, 1.43]cLDA model
Comparison: Serotype 5: GMT Ratio V114 Lot 1 / V114 Lot 2p-value: <0.00195% CI: [0.7, 1.02]cLDA model
Comparison: Serotype 5: GMT Ratio V114 Lot 1 / V114 Lot 3p-value: <0.00195% CI: [0.83, 1.2]cLDA model
Comparison: Serotype 5: GMT Ratio V114 Lot 2 / V114 Lot 3p-value: <0.00195% CI: [0.98, 1.42]cLDA model
Comparison: Serotype 6A: GMT Ratio V114 Lot 1 / V114 Lot 2p-value: <0.00195% CI: [0.82, 1.12]cLDA model
Comparison: Serotype 6A: GMT Ratio V114 Lot 1 / V114 Lot 3p-value: <0.00195% CI: [0.82, 1.12]cLDA model
Comparison: Serotype 6A: GMT Ratio V114 Lot 2 / V114 Lot 3p-value: <0.00195% CI: [0.85, 1.16]cLDA model
Comparison: Serotype 6B: GMT Ratio V114 Lot 1 / V114 Lot 2p-value: <0.00195% CI: [0.82, 1.12]cLDA model
Comparison: Serotype 6B: GMT Ratio V114 Lot 1 / V114 Lot 3p-value: <0.00195% CI: [0.86, 1.18]cLDA model
Comparison: Serotype 6B: GMT Ratio V114 Lot 2 / V114 Lot 3p-value: <0.00195% CI: [0.9, 1.23]cLDA model
Comparison: Serotype 7F: GMT Ratio V114 Lot 1 / V114 Lot 2p-value: <0.00195% CI: [0.72, 0.93]cLDA model
Comparison: Serotype 7F: GMT Ratio V114 Lot 1 / V114 Lot 3p-value: <0.00195% CI: [0.79, 1.01]cLDA model
Comparison: Serotype 7F: GMT Ratio V114 Lot 2 / V114 Lot 3p-value: <0.00195% CI: [0.96, 1.24]cLDA model
Comparison: Serotype 9V: GMT Ratio V114 Lot 1 / V114 Lot 2p-value: <0.00195% CI: [0.88, 1.16]cLDA model
Comparison: Serotype 9V: GMT Ratio V114 Lot 1 / V114 Lot 3p-value: <0.00195% CI: [0.85, 1.12]cLDA model
Comparison: Serotype 9V: GMT Ratio V114 Lot 2 / V114 Lot 3p-value: <0.00195% CI: [0.84, 1.11]cLDA model
Comparison: Serotype 14: GMT Ratio V114 Lot 1 / V114 Lot 2p-value: <0.00195% CI: [0.81, 1.1]cLDA model
Comparison: Serotype 14: GMT Ratio V114 Lot 1 / V114 Lot 3p-value: <0.00195% CI: [0.99, 1.34]cLDA model
Comparison: Serotype 14: GMT Ratio V114 Lot 2 / V114 Lot 3p-value: <0.00195% CI: [1.05, 1.43]cLDA model
Comparison: Serotype 18C: GMT Ratio V114 Lot 1 / V114 Lot 2p-value: <0.00195% CI: [0.96, 1.26]cLDA model
Comparison: Serotype 18C: GMT Ratio V114 Lot 1 / V114 Lot 3p-value: <0.00195% CI: [1, 1.31]cLDA model
Comparison: Serotype 18C: GMT Ratio V114 Lot 2 / V114 Lot 3p-value: <0.00195% CI: [0.91, 1.19]cLDA model
Comparison: Serotype 19A: GMT Ratio V114 Lot 1 / V114 Lot 2p-value: <0.00195% CI: [0.79, 1.02]cLDA model
Comparison: Serotype 19A: GMT Ratio V114 Lot 1 / V114 Lot 3p-value: <0.00195% CI: [0.85, 1.1]cLDA model
Comparison: Serotype 19A: GMT Ratio V114 Lot 2 / V114 Lot 3p-value: <0.00195% CI: [0.95, 1.22]cLDA model
Comparison: Serotype 19F: GMT Ratio V114 Lot 1 / V114 Lot 2p-value: <0.00195% CI: [0.81, 1.05]cLDA model
Comparison: Serotype 19F: GMT Ratio V114 Lot 1 / V114 Lot 3p-value: <0.00195% CI: [0.82, 1.07]cLDA model
Comparison: Serotype 19F: GMT Ratio V114 Lot 2 / V114 Lot 3p-value: <0.00195% CI: [0.89, 1.15]cLDA model
Comparison: Serotype 23F: GMT Ratio V114 Lot 1 / V114 Lot 2p-value: <0.00195% CI: [0.77, 1.1]cLDA model
Comparison: Serotype 23F: GMT Ratio V114 Lot 1 / V114 Lot 3p-value: <0.00195% CI: [0.87, 1.24]cLDA model
Comparison: Serotype 23F: GMT Ratio V114 Lot 2 / V114 Lot 3p-value: <0.00195% CI: [0.95, 1.35]cLDA model
Comparison: Serotype 22F: GMT Ratio V114 Lot 1 / V114 Lot 2p-value: <0.00195% CI: [0.81, 1.11]cLDA model
Comparison: Serotype 22F: GMT Ratio V114 Lot 1 / V114 Lot 3p-value: <0.00195% CI: [0.84, 1.14]cLDA model
Comparison: Serotype 22F: GMT Ratio V114 Lot 2 / V114 Lot 3p-value: <0.00195% CI: [0.88, 1.21]cLDA model
Comparison: Serotype 33F: GMT Ratio V114 Lot 1 / V114 Lot 2p-value: <0.00195% CI: [0.86, 1.16]cLDA model
Comparison: Serotype 33F: GMT Ratio V114 Lot 1 / V114 Lot 3p-value: <0.00195% CI: [0.91, 1.22]cLDA model
Comparison: Serotype 33F: GMT Ratio V114 Lot 2 / V114 Lot 3p-value: <0.00195% CI: [0.9, 1.22]cLDA model
Primary
Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of redness/erythema, swelling, and tenderness/pain. Per the statistical analysis plan, within-group CIs were not calculated.
Time frame: Up to Day 5
Population: Randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 Lot 1 | Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Injection site erythema | 10.9 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Injection site pain | 66.8 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Injection site swelling | 15.4 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Injection site erythema | 9.6 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Injection site pain | 52.2 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Injection site swelling | 14.3 Percentage of participants |
Comparison: Injection site erythema: V114 Combined Lots - Prevnar 13™p-value: 0.53895% CI: [-3.3, 4.8]Miettinen & Nurminen
Comparison: Injection site pain: V114 Combined Lots - Prevnar 13™p-value: <0.00195% CI: [7.9, 21.4]Miettinen & Nurminen
Comparison: Injection site swelling: V114 Combined Lots - Prevnar 13™p-value: 0.68695% CI: [-4.3, 5.3]Miettinen & Nurminen
Primary
Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With Separate V114 Lots
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of redness/erythema, swelling, and tenderness/pain. The 95% confidence interval (CI) were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with solicited injection-site AEs was assessed. Per the statistical analysis plan, the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.
Time frame: Up to Day 5
Population: Randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 Lot 1 | Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With Separate V114 Lots | Injection site pain | 66.1 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With Separate V114 Lots | Injection site erythema | 10.2 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With Separate V114 Lots | Injection site swelling | 15.6 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With Separate V114 Lots | Injection site pain | 67.0 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With Separate V114 Lots | Injection site erythema | 11.5 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With Separate V114 Lots | Injection site swelling | 15.8 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With Separate V114 Lots | Injection site erythema | 11.0 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With Separate V114 Lots | Injection site swelling | 14.7 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With Separate V114 Lots | Injection site pain | 67.3 Percentage of participants |
Primary
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consisted of muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. Per the statistical analysis plan, within-group CIs were not calculated.
Time frame: Up to Day 14
Population: Randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 Lot 1 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Arthralgia | 7.7 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Fatigue | 21.5 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Headache | 18.9 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Myalgia | 26.9 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Myalgia | 21.7 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Arthralgia | 5.7 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Headache | 18.7 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Fatigue | 22.2 Percentage of participants |
Comparison: Arthralgia: V114 Combined Lots - Prevnar 13™p-value: 0.27295% CI: [-1.9, 4.7]Miettinen & Nurminen
Comparison: Fatigue: V114 Combined Lots - Prevnar 13™p-value: 0.81295% CI: [-6.7, 4.5]Miettinen & Nurminen
Comparison: Headache: V114 Combined Lots - Prevnar 13™p-value: 0.94795% CI: [-5.6, 5]Miettinen & Nurminen
Comparison: Myalgia: V114 Combined Lots - Prevnar 13™p-value: 0.09195% CI: [-0.9, 10.4]Miettinen & Nurminen
Primary
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With Separate V114 Lots
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consisted of muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with solicited systemic AEs was assessed. Per the statistical analysis plan, the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.
Time frame: Up to Day 14
Population: Randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 Lot 1 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With Separate V114 Lots | Arthralgia | 7.6 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With Separate V114 Lots | Fatigue | 22.0 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With Separate V114 Lots | Headache | 18.2 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With Separate V114 Lots | Myalgia | 28.0 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With Separate V114 Lots | Myalgia | 24.3 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With Separate V114 Lots | Arthralgia | 7.0 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With Separate V114 Lots | Headache | 19.9 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With Separate V114 Lots | Fatigue | 20.9 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With Separate V114 Lots | Myalgia | 28.4 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With Separate V114 Lots | Fatigue | 21.6 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With Separate V114 Lots | Headache | 18.6 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With Separate V114 Lots | Arthralgia | 8.4 Percentage of participants |
Primary
Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. Relatedness of an SAE to the study vaccine is determined by the investigator. Per the statistical analysis plan, within-group CIs were not calculated.
Time frame: Up to Month 6
Population: Randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 Lot 1 | Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™ | 0.0 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination: Combined Lots of V114 or Prevnar 13™ | 0.0 Percentage of participants |
Comparison: V114 Combined Lots - Prevnar 13™95% CI: [-1.6, 0.2]
Primary
Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination With Separate V114 Lots
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. Relatedness of an SAE to the study vaccine is determined by the investigator. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson. Following vaccination with the three lots of V114 the percentage of participants with SAEs was assessed. Per the statistical analysis plan, the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.
Time frame: Up to Month 6
Population: Randomized participants according to the intervention they actually received. One participant randomized to the Prevnar 13™ group incorrectly received V114 Lot 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 Lot 1 | Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination With Separate V114 Lots | 0.0 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination With Separate V114 Lots | 0.0 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination With Separate V114 Lots | 0.0 Percentage of participants |
Secondary
Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™
The GMC of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by ECL. Per the statistical analysis plan, within-group CIs were not calculated,
Time frame: Day 30
Population: All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 6A | 8.38 μg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 14 | 9.89 μg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 3 | 0.77 μg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 18C | 12.08 μg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 6B | 10.92 μg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 19A | 16.18 μg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 5 | 4.14 μg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 19F | 10.52 μg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 7F | 6.19 μg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 23F | 7.58 μg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 4 | 1.87 μg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 22F | 4.10 μg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 9V | 4.30 μg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 33F | 10.03 μg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 1 | 3.91 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 33F | 1.07 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 1 | 5.22 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 3 | 0.55 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 4 | 2.38 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 5 | 4.66 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 6A | 7.20 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 6B | 7.28 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 7F | 7.12 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 9V | 4.97 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 14 | 9.97 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 18C | 9.58 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 19A | 16.66 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 19F | 10.25 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 23F | 6.03 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific IgG Following Vaccination: Combined Lots of V114 or Prevnar 13™ | Serotype 22F | 0.34 μg/mL |
Comparison: Serotype 1: GMC Ratio V114 Combined Lots / Prevnar 13™95% CI: [0.62, 0.91]
Comparison: Serotype 3: GMC Ratio V114 Combined Lots / Prevnar 13™95% CI: [1.2, 1.61]
Comparison: Serotype 4: GMC Ratio V114 Combined Lots / Prevnar 13™95% CI: [0.66, 0.94]
Comparison: Serotype 5: GMC Ratio V114 Combined Lots / Prevnar 13™95% CI: [0.74, 1.07]
Comparison: Serotype 6A: GMC Ratio V114 Combined Lots / Prevnar 13™95% CI: [0.95, 1.43]
Comparison: Serotype 6B: GMC Ratio V114 Combined Lots / Prevnar 13™95% CI: [1.21, 1.86]
Comparison: Serotype 7F: GMC Ratio V114 Combined Lots / Prevnar 13™95% CI: [0.73, 1.04]
Comparison: Serotype 9V: GMC Ratio V114 Combined Lots / Prevnar 13™95% CI: [0.72, 1.04]
Comparison: Serotype 14: GMC Ratio V114 Combined Lots / Prevnar 13™95% CI: [0.82, 1.2]
Comparison: Serotype 18C: GMC Ratio V114 Combined Lots / Prevnar 13™95% CI: [1.05, 1.51]
Comparison: Serotype 19A: GMC Ratio V114 Combined Lots / Prevnar 13™95% CI: [0.82, 1.15]
Comparison: Serotype 19F: GMC Ratio V114 Combined Lots / Prevnar 13™95% CI: [0.86, 1.23]
Comparison: Serotype 23F: GMC Ratio V114 Combined Lots / Prevnar 13™95% CI: [1.03, 1.54]
Comparison: Serotype 22F: GMC Ratio V114 Combined Lots / Prevnar 13™95% CI: [10.11, 14.74]
Comparison: Serotype 33F: GMC Ratio V114 Combined Lots / Prevnar 13™95% CI: [7.96, 11.13]
Secondary
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots
The geometric mean concentration (GMC) of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by multiplex electrochemiluminescence (ECL) using the pneumococcal electrochemiluminescence (PnECL) v2.0 assay. Per the statistical analysis plan, within-group CIs were not calculated; and the Prevnar 13™ treatment group was not included as it was not analyzed with the same approach as the separate V114 lots.
Time frame: Day 30
Population: All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 6B | 10.92 μg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 4 | 1.79 μg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 19A | 15.45 μg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 7F | 5.71 μg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 3 | 0.74 μg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 18C | 14.07 μg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 9V | 4.20 μg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 23F | 7.38 μg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 14 | 9.82 μg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 5 | 3.81 μg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 33F | 9.92 μg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 1 | 3.91 μg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 6A | 8.09 μg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 22F | 4.12 μg/mL |
| V114 Lot 1 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 19F | 9.78 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 19F | 11.22 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 1 | 4.05 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 3 | 0.86 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 4 | 2.18 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 5 | 4.63 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 6A | 8.84 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 6B | 11.46 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 7F | 7.11 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 9V | 4.44 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 14 | 11.38 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 18C | 11.81 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 19A | 17.34 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 23F | 7.97 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 22F | 4.41 μg/mL |
| V114 Lot 2 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 33F | 10.88 μg/mL |
| V114 Lot 3 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 6B | 10.44 μg/mL |
| V114 Lot 3 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 22F | 3.80 μg/mL |
| V114 Lot 3 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 19A | 15.81 μg/mL |
| V114 Lot 3 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 6A | 8.16 μg/mL |
| V114 Lot 3 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 5 | 3.96 μg/mL |
| V114 Lot 3 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 19F | 10.65 μg/mL |
| V114 Lot 3 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 4 | 1.67 μg/mL |
| V114 Lot 3 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 1 | 3.83 μg/mL |
| V114 Lot 3 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 23F | 7.44 μg/mL |
| V114 Lot 3 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 9V | 4.26 μg/mL |
| V114 Lot 3 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 3 | 0.73 μg/mL |
| V114 Lot 3 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 14 | 8.66 μg/mL |
| V114 Lot 3 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 7F | 5.94 μg/mL |
| V114 Lot 3 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 33F | 9.45 μg/mL |
| V114 Lot 3 | Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) Following Vaccination With Separate V114 Lots | Serotype 18C | 10.66 μg/mL |
Comparison: Serotype 1: GMC Ratio V114 Lot 1 / V114 Lot 295% CI: [0.84, 1.1]
Comparison: Serotype 1: GMC Ratio V114 Lot 1 / V114 Lot 395% CI: [0.89, 1.17]
Comparison: Serotype 1: GMC Ratio V114 Lot 2 / V114 Lot 395% CI: [0.92, 1.21]
Comparison: Serotype 3: GMC Ratio V114 Lot 1 / V114 Lot 295% CI: [0.77, 0.95]
Comparison: Serotype 3: GMC Ratio V114 Lot 1 / V114 Lot 395% CI: [0.91, 1.13]
Comparison: Serotype 3: GMC Ratio V114 Lot 2 / V114 Lot 395% CI: [1.06, 1.32]
Comparison: Serotype 4: GMC Ratio V114 Lot 1 / V114 Lot 295% CI: [0.72, 0.94]
Comparison: Serotype 4: GMC Ratio V114 Lot 1 / V114 Lot 395% CI: [0.94, 1.23]
Comparison: Serotype 4: GMC Ratio V114 Lot 2 / V114 Lot 395% CI: [1.14, 1.5]
Comparison: Serotype 5: GMC Ratio V114 Lot 1 / V114 Lot 295% CI: [0.72, 0.95]
Comparison: Serotype 5: GMC Ratio V114 Lot 1 / V114 Lot 395% CI: [0.84, 1.11]
Comparison: Serotype 5: GMC Ratio V114 Lot 2 / V114 Lot 395% CI: [1.02, 1.35]
Comparison: Serotype 6A: GMC Ratio V114 Lot 1 / V114 Lot 295% CI: [0.78, 1.07]
Comparison: Serotype 6A: GMC Ratio V114 Lot 1 / V114 Lot 395% CI: [0.85, 1.16]
Comparison: Serotype 6A: GMC Ratio V114 Lot 2 / V114 Lot 395% CI: [0.93, 1.27]
Comparison: Serotype 6B: GMC Ratio V114 Lot 1 / V114 Lot 295% CI: [0.82, 1.11]
Comparison: Serotype 6B: GMC Ratio V114 Lot 1 / V114 Lot 395% CI: [0.9, 1.22]
Comparison: Serotype 6B: GMC Ratio V114 Lot 2 / V114 Lot 395% CI: [0.94, 1.28]
Comparison: Serotype 7F: GMC Ratio V114 Lot 1 / V114 Lot 295% CI: [0.7, 0.92]
Comparison: Serotype 7F: GMC Ratio V114 Lot 1 / V114 Lot 395% CI: [0.84, 1.1]
Comparison: Serotype 7F: GMC Ratio V114 Lot 2 / V114 Lot 395% CI: [1.04, 1.37]
Comparison: Serotype 9V: GMC Ratio V114 Lot 1 / V114 Lot 295% CI: [0.83, 1.08]l
Comparison: Serotype 9V: GMC Ratio V114 Lot 1 / V114 Lot 395% CI: [0.87, 1.13]
Comparison: Serotype 9V: GMC Ratio V114 Lot 2 / V114 Lot 395% CI: [0.91, 1.19]
Comparison: Serotype 14: GMC Ratio V114 Lot 1 / V114 Lot 295% CI: [0.75, 1]
Comparison: Serotype 14: GMC Ratio V114 Lot 1 / V114 Lot 395% CI: [0.98, 1.31]
Comparison: Serotype 14: GMC Ratio V114 Lot 2 / V114 Lot 395% CI: [1.14, 1.52]
Comparison: Serotype 18C: GMC Ratio V114 Lot 1 / V114 Lot 295% CI: [1.04, 1.36]
Comparison: Serotype 18C: GMC Ratio V114 Lot 1 / V114 Lot 395% CI: [1.15, 1.51]
Comparison: Serotype 18C: GMC Ratio V114 Lot 2 / V114 Lot 395% CI: [0.97, 1.27]
Comparison: Serotype 19A: GMC Ratio V114 Lot 1 / V114 Lot 295% CI: [0.78, 1.02]
Comparison: Serotype 19A: GMC Ratio V114 Lot 1 / V114 Lot 395% CI: [0.86, 1.11]
Comparison: Serotype 19A: GMC Ratio V114 Lot 2 / V114 Lot 395% CI: [0.96, 1.25]
Comparison: Serotype 19F: GMC Ratio V114 Lot 1 / V114 Lot 295% CI: [0.76, 1]
Comparison: Serotype 19F: GMC Ratio V114 Lot 1 / V114 Lot 395% CI: [0.8, 1.05]
Comparison: Serotype 19F: GMC Ratio V114 Lot 2 / V114 Lot 395% CI: [0.92, 1.21]
Comparison: Serotype 23F: GMC Ratio V114 Lot 1 / V114 Lot 295% CI: [0.8, 1.07]
Comparison: Serotype 23F: GMC Ratio V114 Lot 1 / V114 Lot 395% CI: [0.86, 1.15]
Comparison: Serotype 23F: GMC Ratio V114 Lot 2 / V114 Lot 395% CI: [0.93, 1.24]
Comparison: Serotype 22F: GMC Ratio V114 Lot 1 / V114 Lot 295% CI: [0.81, 1.08]
Comparison: Serotype 22F: GMC Ratio V114 Lot 1 / V114 Lot 395% CI: [0.93, 1.26]
Comparison: Serotype 22F: GMC Ratio V114 Lot 2 / V114 Lot 395% CI: [1, 1.35]
Comparison: Serotype 33F: GMC Ratio V114 Lot 1 / V114 Lot 295% CI: [0.79, 1.06]
Comparison: Serotype 33F: GMC Ratio V114 Lot 1 / V114 Lot 395% CI: [0.9, 1.22]
Comparison: Serotype 33F: GMC Ratio V114 Lot 2 / V114 Lot 395% CI: [0.99, 1.34]
Secondary
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the MOPA which reads the reciprocal of the highest dilution that gives ≥50% bacterial killing. The Geometric Mean Fold Rise (GMFR) is the geometric mean of the ratio Day 30/Day 1 OPA responses. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed.
Time frame: Day 1 (Baseline) and Day 30
Population: All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 Lot 1 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 23F | 16.8 Ratio |
| V114 Lot 1 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 18C | 16.7 Ratio |
| V114 Lot 1 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 4 | 17.4 Ratio |
| V114 Lot 1 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 22F | 27.2 Ratio |
| V114 Lot 1 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 14 | 7.6 Ratio |
| V114 Lot 1 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 3 | 6.5 Ratio |
| V114 Lot 1 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 33F | 8.4 Ratio |
| V114 Lot 1 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 6A | 13.7 Ratio |
| V114 Lot 1 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 1 | 15.9 Ratio |
| V114 Lot 1 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 19A | 10.4 Ratio |
| V114 Lot 1 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 7F | 11.9 Ratio |
| V114 Lot 1 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 9V | 4.8 Ratio |
| V114 Lot 1 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 19F | 6.5 Ratio |
| V114 Lot 1 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 6B | 33.4 Ratio |
| V114 Lot 1 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 5 | 11.2 Ratio |
| V114 Lot 2 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 5 | 13.3 Ratio |
| V114 Lot 2 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 9V | 4.8 Ratio |
| V114 Lot 2 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 14 | 7.6 Ratio |
| V114 Lot 2 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 18C | 15.0 Ratio |
| V114 Lot 2 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 19A | 11.0 Ratio |
| V114 Lot 2 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 19F | 6.8 Ratio |
| V114 Lot 2 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 23F | 17.4 Ratio |
| V114 Lot 2 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 22F | 31.1 Ratio |
| V114 Lot 2 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 33F | 7.7 Ratio |
| V114 Lot 2 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 1 | 16.5 Ratio |
| V114 Lot 2 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 3 | 7.6 Ratio |
| V114 Lot 2 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 4 | 20.7 Ratio |
| V114 Lot 2 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 6A | 14.1 Ratio |
| V114 Lot 2 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 6B | 31.2 Ratio |
| V114 Lot 2 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 7F | 14.3 Ratio |
| V114 Lot 3 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 23F | 17.0 Ratio |
| V114 Lot 3 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 6B | 34.9 Ratio |
| V114 Lot 3 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 4 | 16.5 Ratio |
| V114 Lot 3 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 19F | 7.3 Ratio |
| V114 Lot 3 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 19A | 11.7 Ratio |
| V114 Lot 3 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 5 | 11.1 Ratio |
| V114 Lot 3 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 18C | 14.1 Ratio |
| V114 Lot 3 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 9V | 5.0 Ratio |
| V114 Lot 3 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 6A | 14.6 Ratio |
| V114 Lot 3 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 33F | 7.5 Ratio |
| V114 Lot 3 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 14 | 6.2 Ratio |
| V114 Lot 3 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 1 | 15.4 Ratio |
| V114 Lot 3 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 22F | 28.3 Ratio |
| V114 Lot 3 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 7F | 12.9 Ratio |
| V114 Lot 3 | Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 3 | 6.9 Ratio |
Secondary
GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots
The geometric mean concentration (GMC) of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by ECL. The GMFR is the geometric mean of the ratio Day 30/Day 1 IgG concentration. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed.
Time frame: Day 1 (Baseline) and Day 30
Population: All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 Lot 1 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 19A | 9.1 Ratio |
| V114 Lot 1 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 6B | 23.5 Ratio |
| V114 Lot 1 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 18C | 20.6 Ratio |
| V114 Lot 1 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 14 | 6.5 Ratio |
| V114 Lot 1 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 7F | 11.7 Ratio |
| V114 Lot 1 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 22F | 12.8 Ratio |
| V114 Lot 1 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 9V | 9.5 Ratio |
| V114 Lot 1 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 4 | 8.6 Ratio |
| V114 Lot 1 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 33F | 9.2 Ratio |
| V114 Lot 1 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 23F | 14.3 Ratio |
| V114 Lot 1 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 5 | 4.5 Ratio |
| V114 Lot 1 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 3 | 5.4 Ratio |
| V114 Lot 1 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 19F | 12.3 Ratio |
| V114 Lot 1 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 6A | 22.6 Ratio |
| V114 Lot 1 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 1 | 10.9 Ratio |
| V114 Lot 2 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 6B | 24.1 Ratio |
| V114 Lot 2 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 1 | 11.2 Ratio |
| V114 Lot 2 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 3 | 6.3 Ratio |
| V114 Lot 2 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 4 | 10.5 Ratio |
| V114 Lot 2 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 5 | 5.5 Ratio |
| V114 Lot 2 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 6A | 24.1 Ratio |
| V114 Lot 2 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 7F | 14.8 Ratio |
| V114 Lot 2 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 9V | 9.8 Ratio |
| V114 Lot 2 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 14 | 6.8 Ratio |
| V114 Lot 2 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 18C | 17.0 Ratio |
| V114 Lot 2 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 19A | 10.6 Ratio |
| V114 Lot 2 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 19F | 13.8 Ratio |
| V114 Lot 2 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 23F | 16.2 Ratio |
| V114 Lot 2 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 22F | 13.4 Ratio |
| V114 Lot 2 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 33F | 9.5 Ratio |
| V114 Lot 3 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 18C | 15.9 Ratio |
| V114 Lot 3 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 6A | 22.9 Ratio |
| V114 Lot 3 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 33F | 7.9 Ratio |
| V114 Lot 3 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 19A | 9.5 Ratio |
| V114 Lot 3 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 5 | 4.7 Ratio |
| V114 Lot 3 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 22F | 11.1 Ratio |
| V114 Lot 3 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 4 | 7.9 Ratio |
| V114 Lot 3 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 7F | 12.0 Ratio |
| V114 Lot 3 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 1 | 10.3 Ratio |
| V114 Lot 3 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 9V | 9.6 Ratio |
| V114 Lot 3 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 6B | 22.1 Ratio |
| V114 Lot 3 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 23F | 14.8 Ratio |
| V114 Lot 3 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 14 | 5.2 Ratio |
| V114 Lot 3 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 19F | 13.1 Ratio |
| V114 Lot 3 | GMFR in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 3 | 5.2 Ratio |
Secondary
Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots
The geometric mean concentration of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by ECL. Percentage of participants with a ≥ 4-fold change from Day 1 (baseline) to Day 30 (Day 30/ Day 1) are presented. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed.
Time frame: Day 1 (Baseline) and Day 30
Population: All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 3 | 58.6 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 18C | 84.6 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 6B | 87.0 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 1 | 73.9 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 14 | 54.4 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 7F | 75.3 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 22F | 75.3 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 9V | 72.6 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 4 | 68.8 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 23F | 76.1 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 19F | 77.8 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 5 | 45.6 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 33F | 69.4 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 19A | 70.6 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 6A | 86.6 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 14 | 57.9 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 1 | 75.2 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 3 | 61.9 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 4 | 73.8 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 5 | 52.5 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 6A | 87.2 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 6B | 85.6 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 7F | 78.8 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 9V | 73.0 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 18C | 78.6 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 19A | 74.2 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 19F | 79.0 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 23F | 80.7 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 22F | 75.4 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 33F | 70.9 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 3 | 54.7 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 18C | 76.7 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 5 | 45.9 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 33F | 66.1 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 4 | 65.7 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 22F | 72.1 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 19F | 78.6 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 1 | 73.0 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 7F | 74.8 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 23F | 76.7 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 9V | 71.6 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 6B | 84.2 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 19A | 71.0 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 14 | 48.3 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific IgG Following Vaccination With Separate V114 Lots | Serotype 6A | 83.8 Percentage of participants |
Secondary
Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots
Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, with the MOPA which reads the reciprocal of the highest dilution (1/dil) that gives ≥50% bacterial killing. Percentage of participants with a ≥ 4-fold change from Day 1 (baseline) to Day 30 (Day 30/Day 1) are presented. Per the statistical analysis plan, the Prevnar 13™ treatment group was not analyzed.
Time frame: Day 1 (Baseline) and Day 30
Population: All randomized participants without deviations from the protocol that may substantially affect the results of the outcome measure. Deviations include randomized but not vaccinated, missing results for serotypes, blood drawn out of time window, prohibited concomitant medication or vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 6B | 83.3 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 22F | 71.1 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 19A | 67.8 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 7F | 69.4 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 4 | 79.4 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 18C | 80.1 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 9V | 53.4 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 33F | 59.5 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 14 | 56.8 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 5 | 71.3 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 3 | 64.7 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 23F | 75.4 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 6A | 78.5 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 1 | 74.4 Percentage of participants |
| V114 Lot 1 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 19F | 60.8 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 19F | 61.9 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 1 | 76.8 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 3 | 68.9 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 4 | 83.6 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 5 | 76.1 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 6A | 77.8 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 6B | 83.6 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 7F | 71.6 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 9V | 51.2 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 14 | 57.6 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 18C | 79.0 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 19A | 69.8 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 23F | 78.3 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 22F | 73.4 Percentage of participants |
| V114 Lot 2 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 33F | 58.3 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 6B | 84.5 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 22F | 72.8 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 19A | 71.2 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 6A | 76.9 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 4 | 79.5 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 19F | 63.0 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 5 | 69.5 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 1 | 77.2 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 23F | 78.2 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 9V | 53.2 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 3 | 64.8 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 14 | 52.3 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 7F | 70.4 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 33F | 56.8 Percentage of participants |
| V114 Lot 3 | Percentage of Participants With ≥4 Fold Change in Serotype-specific OPA Following Vaccination With Separate V114 Lots | Serotype 18C | 78.3 Percentage of participants |