Pneumococcal Infections
Conditions
Brief summary
The purpose of this study is to 1) evaluate the safety and tolerability of V114 and 2) to compare the immune responses of the 15 serotypes contained in V114 with V114 versus Prevnar 13™. The primary hypotheses are that 1) V114 is noninferior to Prevnar 13™ as measured by the serotype specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) for 13 shared serotypes at 30 days postvaccination and that 2) V114 is superior to Prevnar 13™ as measured by serotype-specific OPA GMTs for 2 unique serotypes in V114 at 30 days postvaccination.
Interventions
BIOLOGICALV114
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.
BIOLOGICALPrevnar 13®
13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 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. * Male or female ≥50 years of age at the time of signing the informed consent. (For Japan only: Is male or female ≥65 years of age at the time of signing the informed consent) * 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. * Provides written informed consent for the study. The participant may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research.
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 (IM) 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. * 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. * 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 |
|---|---|---|
| Percentage of Participants With a Solicited Injection-site Adverse Event | Up to Day 5 postvaccination | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consist of redness/erythema, swelling, and tenderness/pain. |
| Percentage of Participants With Solicited Systemic Adverse Events | Up to Day 14 postvaccination | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. |
| Percentage of Participants With a Vaccine-related Serious Adverse Event | 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. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized. |
| Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Day 30 | Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) (estimated) and GMT ratios with 95% CIs and 1-sided p-values were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated. OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) were determined using a multiplexed opsonophagocytic assay (MOPA). The measure type of number presented in the data table below for serotype-specific OPA titer is the geometric mean. |
| Percentage of Participants With ≥4 Fold Rise in Serotype-specific OPA for 2 Unique V114 Serotypes | Day 1 (Baseline) and Day 30 | Activity for the serotypes contained in Prevnar 13™ and V114 was determined using a multiplexed opsonophagocytic assay (MOPA). The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline (Day 1) to 30 days postvaccination (Day 30) for OPA responses for the 2 unique serotypes in V114. The observed response percentage (m/n) included: m=the number of participants with the indicated response divided by n=the number of participants contributing to the analysis. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the percentage point difference); within-group CIs were not calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Day 1 (Baseline) and Day 30 | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplexed opsonophagocytic assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination. |
| GMT of Serotype-specific OPA for Serotype 3 at Day 30 | Day 30 | Serotype-specific OPA GMTs (estimated) and GMT ratios with 95% CIs and 1-sided p-values were calculated using a cLDA model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated. OPA for serotype 3 contained in Prevnar 13™ and V114 was determined using a MOPA. The measure type of number presented in the data table below for serotype-specific OPA titer is the geometric mean. |
| Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Day 1 (Baseline) and Day 30 | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The percentage of participants who had ≥4-fold rise in IgG concentration are calculated from baseline to postvaccination. |
| Percentage of Participants With ≥4 Fold Rise in Serotype-specific OPA for Serotype 3 OPA Responses | Day 1 (Baseline) and Day 30 | Activity for serotype 3 contained in Prevnar 13™ and V114 was determined using a MOPA. The observed response percentage of participants (m/n) who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination. n=Number of participants contributing to the analysis; m=Number of participants with the indicated response. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the percentage point difference); within-group CIs were not calculated. |
| Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Day 30 | Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) (estimated) and GMC ratios with 95% confidence intervals (CIs) and 1-sided p-values were calculated using a cLDA model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMC ratios); within-group CIs were not calculated. IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The measure type of number presented in the data table below for serotype-specific IgG concentration is the geometric mean. |
| Geometric Mean Fold Rise in Serotype-specific OPA | Day 1 (Baseline) and Day 30 | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. |
| Geometric Mean Fold Rise in Serotype-specific IgG | Day 1 (Baseline) and Day 30 | Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. |
Countries
Canada, Japan, Spain, Taiwan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| V114 Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1. | 604 |
| Prevnar 13™ Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1. | 601 |
| Total | 1,205 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Lost to Follow-up | 5 | 5 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Protocol Deviation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Prevnar 13™ | Total | V114 |
|---|---|---|---|
| Age, Continuous | 65.7 Years STANDARD_DEVIATION 7.4 | 65.9 Years STANDARD_DEVIATION 7.5 | 66.2 Years STANDARD_DEVIATION 7.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 129 Participants | 264 Participants | 135 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 471 Participants | 940 Participants | 469 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 152 Participants | 302 Participants | 150 Participants |
| Race (NIH/OMB) Black or African American | 37 Participants | 73 Participants | 36 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 11 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 407 Participants | 817 Participants | 410 Participants |
| Sex: Female, Male Female | 332 Participants | 691 Participants | 359 Participants |
| Sex: Female, Male Male | 269 Participants | 514 Participants | 245 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 604 | 1 / 601 |
| other Total, other adverse events | 395 / 602 | 336 / 600 |
| serious Total, serious adverse events | 9 / 602 | 13 / 600 |
Outcome results
Primary
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30
Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) (estimated) and GMT ratios with 95% CIs and 1-sided p-values were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated. OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) were determined using a multiplexed opsonophagocytic assay (MOPA). The measure type of number presented in the data table below for serotype-specific OPA titer is the geometric mean.
Time frame: Day 30
Population: The analysis population included all randomized participants without protocol deviations, such as failure to receive study vaccine or receipt of prohibited medication prior to study vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 5 (Shared) | 447.3 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 14 (Shared) | 1999.3 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 9V (Shared) | 1817.3 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 18C (Shared) | 2757.7 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 6A (Shared) | 5407.2 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 19A (Shared) | 3194.3 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 3 (Shared) | 216.2 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 19F (Shared) | 1695.1 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 6B (Shared) | 4011.7 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 23F (Shared) | 2045.4 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 4 (Shared) | 1125.6 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 22F (Unique to V114) | 2375.2 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 7F (Shared) | 4617.3 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 33F (Unique to V114) | 7994.7 Titers |
| V114 | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 1 (Shared) | 256.3 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 33F (Unique to V114) | 1124.9 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 1 (Shared) | 322.6 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 4 (Shared) | 1661.6 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 5 (Shared) | 563.5 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 6A (Shared) | 5424.5 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 6B (Shared) | 3258.2 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 7F (Shared) | 5880.6 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 9V (Shared) | 2232.9 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 14 (Shared) | 2656.7 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 18C (Shared) | 2583.7 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 19A (Shared) | 3979.8 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 19F (Shared) | 1917.8 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 23F (Shared) | 1740.4 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 22F (Unique to V114) | 74.6 Titers |
| Prevnar 13™ | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at Day 30 | Serotype 3 (Shared) | 135.1 Titers |
Comparison: Serotype 22F (Unique to V114)p-value: <0.00195% CI: [25.35, 39.97]cLDA
Comparison: Serotype 33F (Unique to V114)p-value: <0.00195% CI: [6.07, 8.32]cLDA
Comparison: Serotype 19A (Shared)p-value: <0.00195% CI: [0.7, 0.93]cLDA
Comparison: Serotype 19F (Shared)p-value: <0.00195% CI: [0.76, 1.02]cLDA
Comparison: Serotype 23F (Shared)p-value: <0.00195% CI: [0.96, 1.44]cLDA
Comparison: Serotype 1 (Shared)p-value: <0.00195% CI: [0.66, 0.96]Constrained longitudinal data analysis
Comparison: Serotype 3 (Shared)p-value: <0.00195% CI: [1.38, 1.85]cLDA
Comparison: Serotype 4 (Shared)p-value: <0.00195% CI: [0.57, 0.8]cLDA
Comparison: Serotype 5 (Shared)p-value: <0.00195% CI: [0.64, 0.98]cLDA
Comparison: Serotype 6A (Shared)p-value: <0.00195% CI: [0.84, 1.19]cLDA
Comparison: Serotype 6B (Shared)p-value: <0.00195% CI: [1.02, 1.48]cLDA
Comparison: Serotype 7F (Shared)p-value: <0.00195% CI: [0.68, 0.9]cLDA
Comparison: Serotype 9V (Shared)p-value: <0.00195% CI: [0.7, 0.94]cLDA
Comparison: Serotype 14 (Shared)p-value: <0.00195% CI: [0.64, 0.89]cLDA
Comparison: Serotype 18C (Shared)p-value: <0.00195% CI: [0.91, 1.26]cLDA
Primary
Percentage of Participants With ≥4 Fold Rise in Serotype-specific OPA for 2 Unique V114 Serotypes
Activity for the serotypes contained in Prevnar 13™ and V114 was determined using a multiplexed opsonophagocytic assay (MOPA). The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline (Day 1) to 30 days postvaccination (Day 30) for OPA responses for the 2 unique serotypes in V114. The observed response percentage (m/n) included: m=the number of participants with the indicated response divided by n=the number of participants contributing to the analysis. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the percentage point difference); within-group CIs were not calculated.
Time frame: Day 1 (Baseline) and Day 30
Population: The analysis population included all randomized participants without protocol deviations, such as failure to receive study vaccine or receipt of prohibited medication prior to study vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With ≥4 Fold Rise in Serotype-specific OPA for 2 Unique V114 Serotypes | Serotype 22F (Unique to V114) | 71.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4 Fold Rise in Serotype-specific OPA for 2 Unique V114 Serotypes | Serotype 33F (Unique to V114) | 56.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4 Fold Rise in Serotype-specific OPA for 2 Unique V114 Serotypes | Serotype 33F (Unique to V114) | 6.3 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4 Fold Rise in Serotype-specific OPA for 2 Unique V114 Serotypes | Serotype 22F (Unique to V114) | 14.3 Percentage of Participants |
Comparison: Serotype 22F (Unique to V114)p-value: <0.00195% CI: [52, 61.8]Miettinen & Nurminen
Comparison: Serotype 33F (Unique to V114)p-value: <0.00195% CI: [45.9, 54.9]Miettinen & Nurminen
Primary
Percentage of Participants With a Solicited Injection-site Adverse Event
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consist of redness/erythema, swelling, and tenderness/pain.
Time frame: Up to Day 5 postvaccination
Population: The analysis population included all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection site pain | 54.0 Percentage of Participants |
| V114 | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection site erythema | 9.0 Percentage of Participants |
| V114 | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection site swelling | 12.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection site pain | 42.3 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection site erythema | 11.3 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection site swelling | 11.2 Percentage of Participants |
Comparison: Injection site redness/erythemap-value: 0.17595% CI: [-5.8, 1.1]Miettinen & Nurminen
Comparison: Injection site tenderness/painp-value: <0.00195% CI: [6, 17.2]Miettinen & Nurminen
Comparison: Injection site swellingp-value: 0.48895% CI: [-2.4, 5]Miettinen & Nurminen
Primary
Percentage of Participants With a Vaccine-related Serious Adverse Event
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized.
Time frame: Up to Month 6
Population: The analysis population included all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 | Percentage of Participants With a Vaccine-related Serious Adverse Event | 0.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With a Vaccine-related Serious Adverse Event | 0.0 Percentage of Participants |
Comparison: Vaccine-related SAEs95% CI: [-0.6, 0.6]Miettinen & Nurminen
Primary
Percentage of Participants With Solicited Systemic Adverse Events
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.
Time frame: Up to Day 14 postvaccination
Population: The analysis population included all randomized participants who received study vaccination and were included in the intervention group according to the intervention they received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With Solicited Systemic Adverse Events | Joint pain/arthralgia | 5.3 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Systemic Adverse Events | Tiredness/fatigue | 17.4 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Systemic Adverse Events | Headache | 11.6 Percentage of Participants |
| V114 | Percentage of Participants With Solicited Systemic Adverse Events | Muscle pain/myalgia | 15.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Systemic Adverse Events | Muscle pain/myalgia | 12.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Systemic Adverse Events | Joint pain/arthralgia | 5.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Systemic Adverse Events | Headache | 13.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With Solicited Systemic Adverse Events | Tiredness/fatigue | 17.3 Percentage of Participants |
Comparison: Joint pain/arthralgiap-value: 0.88895% CI: [-2.8, 2.4]Miettinen & Nurminen
Comparison: Tiredness/fatiguep-value: 0.9695% CI: [-4.2, 4.4]Miettinen & Nurminen
Comparison: Headachep-value: 0.46995% CI: [-5.1, 2.4]Miettinen & Nurminen
Comparison: Muscle pain/myalgiap-value: 0.08295% CI: [-0.4, 7.4]Miettinen & Nurminen
Secondary
Geometric Mean Concentration of Serotype-specific IgG at Day 30
Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) (estimated) and GMC ratios with 95% confidence intervals (CIs) and 1-sided p-values were calculated using a cLDA model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMC ratios); within-group CIs were not calculated. IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The measure type of number presented in the data table below for serotype-specific IgG concentration is the geometric mean.
Time frame: Day 30
Population: The analysis population included all randomized participants without protocol deviations, such as failure to receive study vaccine or receipt of prohibited medication prior to study vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 5 (Shared) | 4.57 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 19A (Shared) | 14.60 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 23F (Shared) | 6.67 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 1 (Shared) | 5.30 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 3 (Shared) | 0.96 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 4 (Shared) | 1.88 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 6A (Shared) | 7.21 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 6B (Shared) | 8.60 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 7F (Shared) | 6.18 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 9V (Shared) | 4.77 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 14 (Shared) | 9.39 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 18C (Shared) | 8.99 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 19F (Shared) | 8.77 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 22F (Unique to V114) | 3.44 µg/mL |
| V114 | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 33F (Unique to V114) | 11.05 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 22F (Unique to V114) | 0.32 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 7F (Shared) | 8.09 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 19A (Shared) | 17.38 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 19F (Shared) | 9.70 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 9V (Shared) | 5.52 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 1 (Shared) | 7.34 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 23F (Shared) | 6.13 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 3 (Shared) | 0.64 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 14 (Shared) | 12.30 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 4 (Shared) | 2.62 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 5 (Shared) | 5.56 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 33F (Unique to V114) | 1.23 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 6A (Shared) | 7.01 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 18C (Shared) | 10.00 µg/mL |
| Prevnar 13™ | Geometric Mean Concentration of Serotype-specific IgG at Day 30 | Serotype 6B (Shared) | 6.19 µg/mL |
Comparison: Serotype 1 (Shared)95% CI: [0.62, 0.83]
Comparison: Serotype 3 (Shared)95% CI: [1.33, 1.71]
Comparison: Serotype 4 (Shared)95% CI: [0.62, 0.83]
Comparison: Serotype 5 (Shared)95% CI: [0.7, 0.96]
Comparison: Serotype 6A (Shared)95% CI: [0.87, 1.21]
Comparison: Serotype 6B (Shared)95% CI: [1.17, 1.64]
Comparison: Serotype 7F (Shared)95% CI: [0.66, 0.89]
Comparison: Serotype 9V (Shared)95% CI: [0.75, 1]
Comparison: Serotype 14 (Shared)95% CI: [0.65, 0.89]
Comparison: Serotype 18C (Shared)95% CI: [0.77, 1.05]
Comparison: Serotype 19A (Shared)95% CI: [0.73, 0.97]
Comparison: Serotype 19F (Shared)95% CI: [0.78, 1.05]
Comparison: Serotype 23F (Shared)95% CI: [0.92, 1.28]
Comparison: Serotype 22F (Unique to V114)95% CI: [9.37, 12.03]
Comparison: Serotype 33F (Unique to V114)95% CI: [8, 10.07]
Secondary
Geometric Mean Fold Rise in Serotype-specific IgG
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.
Time frame: Day 1 (Baseline) and Day 30
Population: The analysis population included all randomized participants without protocol deviations, such as failure to receive study vaccine or receipt of prohibited medication prior to study vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 19F (Shared) | 10.9 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 9V (Shared) | 9.9 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 5 (Shared) | 4.7 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 14 (Shared) | 5.1 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 3 (Shared) | 6.8 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 18C (Shared) | 12.8 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 6A (Shared) | 19.9 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 19A (Shared) | 8.7 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 1 (Shared) | 10.6 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 23F (Shared) | 13.5 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 6B (Shared) | 19.1 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 22F (Unique to V114) | 11.7 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 4 (Shared) | 8.0 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 33F (Unique to V114) | 9.1 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 7F (Shared) | 12.3 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 33F (Unique to V114) | 1.0 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 1 (Shared) | 14.7 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 3 (Shared) | 4.7 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 4 (Shared) | 11.2 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 5 (Shared) | 5.8 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 6A (Shared) | 19.7 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 6B (Shared) | 13.8 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 7F (Shared) | 15.8 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 9V (Shared) | 11.1 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 14 (Shared) | 7.2 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 18C (Shared) | 14.3 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 19F (Shared) | 12.5 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 23F (Shared) | 12.2 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 22F (Unique to V114) | 1.1 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific IgG | Serotype 19A (Shared) | 10.6 Ratio |
Secondary
Geometric Mean Fold Rise in Serotype-specific OPA
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline.
Time frame: Day 1 (Baseline) and Day 30
Population: The analysis population included all randomized participants without protocol deviations, such as failure to receive study vaccine or receipt of prohibited medication prior to study vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 19F (Shared) | 6.6 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 9V (Shared) | 5.3 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 5 (Shared) | 12.3 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 14 (Shared) | 6.2 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 3 (Shared) | 7.7 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 18C (Shared) | 11.3 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 6A (Shared) | 13.0 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 19A (Shared) | 10.9 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 1 (Shared) | 14.3 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 23F (Shared) | 16.2 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 6B (Shared) | 26.3 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 22F (Unique to V114) | 28.3 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 4 (Shared) | 17.8 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 33F (Unique to V114) | 7.4 Ratio |
| V114 | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 7F (Shared) | 12.0 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 33F (Unique to V114) | 1.0 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 1 (Shared) | 18.7 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 3 (Shared) | 5.2 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 4 (Shared) | 24.4 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 5 (Shared) | 15.3 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 6A (Shared) | 13.3 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 6B (Shared) | 21.6 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 7F (Shared) | 14.1 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 9V (Shared) | 6.3 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 14 (Shared) | 8.7 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 18C (Shared) | 10.4 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 19F (Shared) | 7.4 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 23F (Shared) | 13.5 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 22F (Unique to V114) | 1.2 Ratio |
| Prevnar 13™ | Geometric Mean Fold Rise in Serotype-specific OPA | Serotype 19A (Shared) | 13.1 Ratio |
Secondary
GMT of Serotype-specific OPA for Serotype 3 at Day 30
Serotype-specific OPA GMTs (estimated) and GMT ratios with 95% CIs and 1-sided p-values were calculated using a cLDA model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated. OPA for serotype 3 contained in Prevnar 13™ and V114 was determined using a MOPA. The measure type of number presented in the data table below for serotype-specific OPA titer is the geometric mean.
Time frame: Day 30
Population: The analysis population included all randomized participants without protocol deviations, such as failure to receive study vaccine or receipt of prohibited medication prior to study vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 | GMT of Serotype-specific OPA for Serotype 3 at Day 30 | 216.2 Titers |
| Prevnar 13™ | GMT of Serotype-specific OPA for Serotype 3 at Day 30 | 135.1 Titers |
Comparison: Serotype 3 (Shared)p-value: <0.00195% CI: [1.38, 1.85]cLDA
Secondary
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The percentage of participants who had ≥4-fold rise in IgG concentration are calculated from baseline to postvaccination.
Time frame: Day 1 (Baseline) and Day 30
Population: The analysis population included all randomized participants without protocol deviations, such as failure to receive study vaccine or receipt of prohibited medication prior to study vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 9V (Shared) | 69.6 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 1 (Shared) | 73.1 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 14 (Shared) | 49.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 6A (Shared) | 83.5 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 18C (Shared) | 73.1 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 4 (Shared) | 65.0 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 19A (Shared) | 67.2 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 6B (Shared) | 82.8 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 19F (Shared) | 69.5 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 3 (Shared) | 61.6 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 23F (Shared) | 74.9 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 7F (Shared) | 73.5 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 22F (Unique to V114) | 71.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 33F (Unique to V114) | 66.5 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 5 (Shared) | 45.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 33F (Unique to V114) | 1.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 1 (Shared) | 78.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 3 (Shared) | 51.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 4 (Shared) | 76.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 5 (Shared) | 53.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 6A (Shared) | 83.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 6B (Shared) | 77.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 7F (Shared) | 78.6 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 9V (Shared) | 75.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 14 (Shared) | 59.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 18C (Shared) | 76.3 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 19A (Shared) | 71.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 19F (Shared) | 75.5 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 23F (Shared) | 74.3 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration | Serotype 22F (Unique to V114) | 1.7 Percentage of Participants |
Secondary
Percentage of Participants With ≥4 Fold Rise in Serotype-specific OPA for Serotype 3 OPA Responses
Activity for serotype 3 contained in Prevnar 13™ and V114 was determined using a MOPA. The observed response percentage of participants (m/n) who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination. n=Number of participants contributing to the analysis; m=Number of participants with the indicated response. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the percentage point difference); within-group CIs were not calculated.
Time frame: Day 1 (Baseline) and Day 30
Population: The analysis population included all randomized participants without protocol deviations, such as failure to receive study vaccine or receipt of prohibited medication prior to study vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 | Percentage of Participants With ≥4 Fold Rise in Serotype-specific OPA for Serotype 3 OPA Responses | 70.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4 Fold Rise in Serotype-specific OPA for Serotype 3 OPA Responses | 58.7 Percentage of Participants |
Comparison: Serotype 3 (Shared) ≥4-Fold Rise in OPAp-value: <0.00195% CI: [6, 16.9]Miettinen & Nurminen
Secondary
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplexed opsonophagocytic assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
Time frame: Day 1 (Baseline) and Day 30
Population: The analysis population included all randomized participants without protocol deviations, such as failure to receive study vaccine or receipt of prohibited medication prior to study vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 6A (Shared) | 76.5 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 14 (Shared) | 52.2 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 3 (Shared) | 70.2 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 18C (Shared) | 71.3 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 6B (Shared) | 81.2 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 19A (Shared) | 70.6 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 5 (Shared) | 71.6 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 19F (Shared) | 62.0 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 7F (Shared) | 66.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 23F (Shared) | 75.0 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 4 (Shared) | 79.5 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 22F (Unique to V114) | 71.4 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 9V (Shared) | 54.0 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 33F (Unique to V114) | 56.7 Percentage of Participants |
| V114 | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 1 (Shared) | 75.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 33F (Unique to V114) | 6.3 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 1 (Shared) | 77.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 3 (Shared) | 58.7 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 4 (Shared) | 84.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 5 (Shared) | 75.3 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 6A (Shared) | 74.9 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 6B (Shared) | 79.2 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 7F (Shared) | 72.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 9V (Shared) | 60.0 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 14 (Shared) | 60.8 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 18C (Shared) | 69.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 19A (Shared) | 71.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 19F (Shared) | 65.1 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 23F (Shared) | 71.4 Percentage of Participants |
| Prevnar 13™ | Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer | Serotype 22F (Unique to V114) | 14.3 Percentage of Participants |