Pneumococcal Infections
Conditions
Keywords
Invasive pneumococcal disease, Pneumonia, Pneumococcal conjugate vaccine
Brief summary
This study will evaluate whether the aluminum-adjuvanted or the non-adjuvanted formulation of the candidate pneumococcal vaccine (V114) is non-inferior to Prevnar 13® based on immune responses to the 13 serotypes in common Prevnar 13®
Interventions
BIOLOGICALV114 Aluminum-adjuvanted
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.2 mcg each), serotype 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.
BIOLOGICALV114 Non-adjuvanted
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose.
BIOLOGICALPrevnar 13®
13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each), serotype 6B (4.4 mcg each) and aluminum phosphate adjuvant (125 mcg) in each 0.5. mL dose.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Healthy infants ≥ 42 days to ≤ 89 days. * Participant's parent/legal guardian understands the study procedures, alternate treatments available and risks involved with the study, and voluntarily agrees to allow the child to participate by giving written informed consent. * Afebrile, with a rectal temperature \<38.1°C (\<100.5°F) or axillary temperature \<37.8°C (\<100.0°F) on day of vaccination. * Participant's parent/legal guardian is able to read, understand, and complete study questionnaires (i.e., the Vaccination Report Card). * Participant is able to attend all scheduled visits and to comply with the study procedures. * Participant's parent/legal guardian has access to a telephone.
Exclusion criteria
* Prior administration of any pneumococcal vaccine. * Known hypersensitivity to any component of the pneumococcal conjugate vaccine. * Known or suspected impairment of immunological function. * Participant has a history of congenital or acquired immunodeficiency (e.g., splenomegaly). * Participant or his/her mother has documented human immunodeficiency virus (HIV) infection. * Functional or anatomic asplenia. * History of autoimmune disease including multiple sclerosis (MS), systemic lupus, polymyositis, inclusion body myositis, dermatomyositis, Hashimoto's thyroiditis, Sjogren's syndrome, rheumatoid arthritis, other autoimmune disorders. * Known neurologic or cognitive behavioral disorders including multiple sclerosis (MS), MS-like disease, encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive developmental disorder, and related disorders. * Use of any immunosuppressive therapy (Note: topical and inhaled/nebulized steroids are permitted). Participants on intramuscular, oral, or intravenous corticosteroid treatment should be excluded if they are receiving or expected to receive in the period from 30 days prior to Visit 1 through Visit 6 (30 days post-dose 4) more than 2 mg/kg per day of prednisone (or its equivalent), or more than 20 mg/d if they weigh more than 10 kg and are not otherwise immunocompromised. Excluded immunosuppressive therapies also include chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation, or autoimmune disease. * Participant has received other licensed non-live vaccines within the 14 days before receipt of study vaccine. * Participant has received a licensed live virus vaccine within the 30 days prior of receipt of study vaccine. * Prior receipt of a blood transfusion or blood products, including immunoglobulins. * Investigational drugs or vaccines received within the 2 months before receipt of study vaccine. * Participation in another clinical study within 42 days before the beginning or anytime during the duration of the current clinical study. * History of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease. * A recent febrile illness (rectal temperature ≥38.1°C \[≥100.5°F\]) occurring within 72 hours before receipt of study vaccine. * History of failure to thrive. * Participant has a coagulation disorder contraindicating IM vaccination. * Participant and his/her mother have documented hepatitis B surface antigen-positive. * Any infant who cannot be adequately followed for safety according to the protocol plan. * Participant's parent/legal guardian is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study. * Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Discontinued the Study Due to an AE | Up to Day 14 postvaccination | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience. |
| Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | One month postvaccination 3 | Percentage of participants meeting the serotype-specific IgG reference level (an antibody concentration measured by the pneumococcal polysaccharide electrochemiluminescence \[Pn ECL\] assay corresponding to the World Health Organization enzyme-linked immunosorbent assay \[WHO ELISA\] ≥ 0.35 μg/mL) (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. |
| IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | One month postvaccination 3 | The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. |
| IgG GMCs for Postvaccination 4 | One month postvaccination 4 | The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. |
| Number of Participants With an Adverse Event (AE) | Up to Day 14 postvaccination | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience. |
| Number of Participants With an Injection-site AE | Up to Day 14 postvaccination | Injection-site AEs reported by \> 0% of participants in one or more vaccination groups were assessed. |
| Number of Participants With a Serious Adverse Event (SAE) | Up to one month after last dose of study vaccine | An SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. |
| Number of Participants With a Systemic AE | Up to Day 14 postvaccination | Systemic AEs reported by \> 0% of participants in one or more vaccination groups were assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | One month postvaccination 4 | The antibody responses as measured by MOPA4 (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses. |
| OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | One month postvaccination 3 | The antibody responses as measured by MOPA4 (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. The OPA antibody responses included the percentage of participants with OPA titer and the GMTs. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses. |
| OPA GMTs as Measured by MOPA4 for Postvaccination 4 | One month postvaccination 4 | The antibody responses as measured by MOPA4 (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses. |
| Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | One month postvaccination 4 | Percentage of participants achieving World Health Organization (WHO) predefined antibody threshold as measured by the pneumococcal polysaccharide electrochemiluminescence (Pn ECL) assay corresponding to the WHO enzyme-linked immunosorbent assay (ELISA) value of ≥ 0.35μg/mL (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. |
| Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | One month postvaccination 4 | Percentage of participants achieving WHO predefined antibody threshold as measured by the Pn ECL assay corresponding to the WHO enzyme-linked immunosorbent assay (ELISA) value of ≥ 1.0 μg/mL (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. |
| Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | One month postvaccination 3 | The antibody responses as measured by MOPA4 (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses. |
Participant flow
Recruitment details
This trial was conducted in 58 trial centers: 4 in Canada, 8 in Finland, 3 in Israel, 1 in Puerto Rico, 3 in Spain and 39 in the United States.
Pre-assignment details
There were 1152 participants randomized into the study. The 1142 participants included in this study excluded 4 subjects who each received a combination of vaccines and who each had a final disposition of completed and excludes an additional 6 subjects who were randomized but never vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| V114 Adjuvanted Participants received four intramuscular (IM) doses at 0.5 mL of aluminum-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age. | 378 |
| V114 Nonadjuvanted Participants received four IM doses at 0.5 mL of non-adjuvanted V114 pneumococcal conjugate vaccine at 2, 4, 6, and 12 to 15 months of age. | 386 |
| PREVNAR 13® Participants received four 0.5 mL IM doses of PREVNAR 13® at 2, 4, 6, and 12 to 15 months of age. | 378 |
| Total | 1,142 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 3 |
| Overall Study | Lack of Efficacy | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 22 | 22 | 16 |
| Overall Study | Physician Decision | 2 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 32 | 34 | 31 |
Baseline characteristics
| Characteristic | V114 Adjuvanted | V114 Nonadjuvanted | PREVNAR 13® | Total |
|---|---|---|---|---|
| Age, Customized | 8.9 Weeks STANDARD_DEVIATION 1.2 | 8.8 Weeks STANDARD_DEVIATION 1.2 | 8.7 Weeks STANDARD_DEVIATION 1.1 | 8.8 Weeks STANDARD_DEVIATION 1.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 70 Participants | 77 Participants | 79 Participants | 226 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 308 Participants | 309 Participants | 299 Participants | 916 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 28 Participants | 31 Participants | 25 Participants | 84 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 5 Participants | 7 Participants | 22 Participants |
| Race (NIH/OMB) Black or African American | 44 Participants | 43 Participants | 40 Participants | 127 Participants |
| Race (NIH/OMB) More than one race | 27 Participants | 18 Participants | 31 Participants | 76 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 268 Participants | 288 Participants | 275 Participants | 831 Participants |
| Sex: Female, Male Female | 177 Participants | 189 Participants | 179 Participants | 545 Participants |
| Sex: Female, Male Male | 201 Participants | 197 Participants | 199 Participants | 597 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 368 | 1 / 382 | 2 / 376 |
| other Total, other adverse events | 345 / 368 | 348 / 382 | 347 / 376 |
| serious Total, serious adverse events | 25 / 368 | 27 / 382 | 29 / 376 |
Outcome results
Primary
IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3
The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
Time frame: One month postvaccination 3
Population: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 Adjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 6A | 0.93 µg/mL |
| V114 Adjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 18C | 1.27 µg/mL |
| V114 Adjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 6B | 0.95 µg/mL |
| V114 Adjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 33F (non-PREVNAR 13® serotype) | 1.47 µg/mL |
| V114 Adjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 14 | 4.17 µg/mL |
| V114 Adjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 7F | 2.63 µg/mL |
| V114 Adjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 9V | 1.49 µg/mL |
| V114 Adjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 23F | 1.05 µg/mL |
| V114 Adjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 22F (non-PREVNAR 13® serotype) | 5.24 µg/mL |
| V114 Adjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 4 | 1.28 µg/mL |
| V114 Adjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 3 | 0.95 µg/mL |
| V114 Adjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 19F | 1.50 µg/mL |
| V114 Adjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 5 | 1.61 µg/mL |
| V114 Adjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 1 | 1.34 µg/mL |
| V114 Adjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 19A | 0.90 µg/mL |
| V114 Nonadjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 4 | 1.26 µg/mL |
| V114 Nonadjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 7F | 2.66 µg/mL |
| V114 Nonadjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 1 | 1.38 µg/mL |
| V114 Nonadjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 3 | 0.88 µg/mL |
| V114 Nonadjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 5 | 1.53 µg/mL |
| V114 Nonadjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 6A | 0.93 µg/mL |
| V114 Nonadjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 6B | 0.69 µg/mL |
| V114 Nonadjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 9V | 1.29 µg/mL |
| V114 Nonadjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 14 | 3.84 µg/mL |
| V114 Nonadjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 18C | 1.08 µg/mL |
| V114 Nonadjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 19A | 0.94 µg/mL |
| V114 Nonadjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 19F | 1.71 µg/mL |
| V114 Nonadjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 22F (non-PREVNAR 13® serotype) | 4.86 µg/mL |
| V114 Nonadjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 23F | 0.79 µg/mL |
| V114 Nonadjuvanted | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 33F (non-PREVNAR 13® serotype) | 1.50 µg/mL |
| PREVNAR 13® | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 18C | 1.99 µg/mL |
| PREVNAR 13® | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 5 | 1.83 µg/mL |
| PREVNAR 13® | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 33F (non-PREVNAR 13® serotype) | 0.06 µg/mL |
| PREVNAR 13® | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 19A | 2.05 µg/mL |
| PREVNAR 13® | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 4 | 1.32 µg/mL |
| PREVNAR 13® | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 23F | 1.41 µg/mL |
| PREVNAR 13® | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 19F | 2.54 µg/mL |
| PREVNAR 13® | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 7F | 3.67 µg/mL |
| PREVNAR 13® | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 3 | 0.50 µg/mL |
| PREVNAR 13® | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 9V | 1.79 µg/mL |
| PREVNAR 13® | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 6B | 1.47 µg/mL |
| PREVNAR 13® | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 1 | 1.84 µg/mL |
| PREVNAR 13® | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 14 | 5.62 µg/mL |
| PREVNAR 13® | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 6A | 2.91 µg/mL |
| PREVNAR 13® | IgG Geometric Mean Concentrations (GMCs) for Postvaccination 3 | Serotype 22F (non-PREVNAR 13® serotype) | 0.07 µg/mL |
Primary
IgG GMCs for Postvaccination 4
The IgG GMCs were evaluated as measured in the Pn ECL assay, for recipients of adjuvanted V114, non-adjuvanted V114, and Prevnar 13® (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
Time frame: One month postvaccination 4
Population: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 Adjuvanted | IgG GMCs for Postvaccination 4 | Serotype 19A | 3.04 µg/mL |
| V114 Adjuvanted | IgG GMCs for Postvaccination 4 | Serotype 6B | 5.24 µg/mL |
| V114 Adjuvanted | IgG GMCs for Postvaccination 4 | Serotype 23F | 1.99 µg/mL |
| V114 Adjuvanted | IgG GMCs for Postvaccination 4 | Serotype 18C | 2.14 µg/mL |
| V114 Adjuvanted | IgG GMCs for Postvaccination 4 | Serotype 7F | 4.18 µg/mL |
| V114 Adjuvanted | IgG GMCs for Postvaccination 4 | Serotype 4 | 1.46 µg/mL |
| V114 Adjuvanted | IgG GMCs for Postvaccination 4 | Serotype 14 | 6.05 µg/mL |
| V114 Adjuvanted | IgG GMCs for Postvaccination 4 | Serotype 9V | 2.82 µg/mL |
| V114 Adjuvanted | IgG GMCs for Postvaccination 4 | Serotype 33F (non-PREVNAR 13® serotype) | 6.29 µg/mL |
| V114 Adjuvanted | IgG GMCs for Postvaccination 4 | Serotype 22F (non-PREVNAR 13® serotype) | 9.64 µg/mL |
| V114 Adjuvanted | IgG GMCs for Postvaccination 4 | Serotype 5 | 1.93 µg/mL |
| V114 Adjuvanted | IgG GMCs for Postvaccination 4 | Serotype 3 | 1.26 µg/mL |
| V114 Adjuvanted | IgG GMCs for Postvaccination 4 | Serotype 19F | 5.56 µg/mL |
| V114 Adjuvanted | IgG GMCs for Postvaccination 4 | Serotype 6A | 3.78 µg/mL |
| V114 Adjuvanted | IgG GMCs for Postvaccination 4 | Serotype 1 | 1.91 µg/mL |
| V114 Nonadjuvanted | IgG GMCs for Postvaccination 4 | Serotype 19F | 6.35 µg/mL |
| V114 Nonadjuvanted | IgG GMCs for Postvaccination 4 | Serotype 1 | 1.81 µg/mL |
| V114 Nonadjuvanted | IgG GMCs for Postvaccination 4 | Serotype 3 | 1.12 µg/mL |
| V114 Nonadjuvanted | IgG GMCs for Postvaccination 4 | Serotype 4 | 1.40 µg/mL |
| V114 Nonadjuvanted | IgG GMCs for Postvaccination 4 | Serotype 5 | 1.79 µg/mL |
| V114 Nonadjuvanted | IgG GMCs for Postvaccination 4 | Serotype 6A | 3.17 µg/mL |
| V114 Nonadjuvanted | IgG GMCs for Postvaccination 4 | Serotype 6B | 3.98 µg/mL |
| V114 Nonadjuvanted | IgG GMCs for Postvaccination 4 | Serotype 7F | 3.43 µg/mL |
| V114 Nonadjuvanted | IgG GMCs for Postvaccination 4 | Serotype 9V | 2.50 µg/mL |
| V114 Nonadjuvanted | IgG GMCs for Postvaccination 4 | Serotype 14 | 5.55 µg/mL |
| V114 Nonadjuvanted | IgG GMCs for Postvaccination 4 | Serotype 18C | 1.68 µg/mL |
| V114 Nonadjuvanted | IgG GMCs for Postvaccination 4 | Serotype 19A | 3.42 µg/mL |
| V114 Nonadjuvanted | IgG GMCs for Postvaccination 4 | Serotype 22F (non-PREVNAR 13® serotype) | 7.73 µg/mL |
| V114 Nonadjuvanted | IgG GMCs for Postvaccination 4 | Serotype 23F | 1.61 µg/mL |
| V114 Nonadjuvanted | IgG GMCs for Postvaccination 4 | Serotype 33F (non-PREVNAR 13® serotype) | 4.95 µg/mL |
| PREVNAR 13® | IgG GMCs for Postvaccination 4 | Serotype 18C | 3.37 µg/mL |
| PREVNAR 13® | IgG GMCs for Postvaccination 4 | Serotype 6A | 6.55 µg/mL |
| PREVNAR 13® | IgG GMCs for Postvaccination 4 | Serotype 19A | 6.14 µg/mL |
| PREVNAR 13® | IgG GMCs for Postvaccination 4 | Serotype 5 | 2.53 µg/mL |
| PREVNAR 13® | IgG GMCs for Postvaccination 4 | Serotype 33F (non-PREVNAR 13® serotype) | 0.08 µg/mL |
| PREVNAR 13® | IgG GMCs for Postvaccination 4 | Serotype 19F | 4.51 µg/mL |
| PREVNAR 13® | IgG GMCs for Postvaccination 4 | Serotype 4 | 1.68 µg/mL |
| PREVNAR 13® | IgG GMCs for Postvaccination 4 | Serotype 23F | 3.14 µg/mL |
| PREVNAR 13® | IgG GMCs for Postvaccination 4 | Serotype 22F (non-PREVNAR 13® serotype) | 0.12 µg/mL |
| PREVNAR 13® | IgG GMCs for Postvaccination 4 | Serotype 9V | 3.37 µg/mL |
| PREVNAR 13® | IgG GMCs for Postvaccination 4 | Serotype 7F | 5.73 µg/mL |
| PREVNAR 13® | IgG GMCs for Postvaccination 4 | Serotype 3 | 0.69 µg/mL |
| PREVNAR 13® | IgG GMCs for Postvaccination 4 | Serotype 14 | 7.57 µg/mL |
| PREVNAR 13® | IgG GMCs for Postvaccination 4 | Serotype 6B | 5.51 µg/mL |
| PREVNAR 13® | IgG GMCs for Postvaccination 4 | Serotype 1 | 2.18 µg/mL |
Primary
Number of Participants Who Discontinued the Study Due to an AE
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience.
Time frame: Up to Day 14 postvaccination
Population: The analysis population included all randomized participants who received at least one dose of study vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| V114 Adjuvanted | Number of Participants Who Discontinued the Study Due to an AE | 1 Participants |
| V114 Nonadjuvanted | Number of Participants Who Discontinued the Study Due to an AE | 1 Participants |
| PREVNAR 13® | Number of Participants Who Discontinued the Study Due to an AE | 2 Participants |
Primary
Number of Participants With an Adverse Event (AE)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience.
Time frame: Up to Day 14 postvaccination
Population: The analysis population included all randomized participants who received at least one dose of study vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| V114 Adjuvanted | Number of Participants With an Adverse Event (AE) | 349 Participants |
| V114 Nonadjuvanted | Number of Participants With an Adverse Event (AE) | 359 Participants |
| PREVNAR 13® | Number of Participants With an Adverse Event (AE) | 354 Participants |
Primary
Number of Participants With an Injection-site AE
Injection-site AEs reported by \> 0% of participants in one or more vaccination groups were assessed.
Time frame: Up to Day 14 postvaccination
Population: The analysis population included all randomized participants who received at least one dose of study vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| V114 Adjuvanted | Number of Participants With an Injection-site AE | 307 Participants |
| V114 Nonadjuvanted | Number of Participants With an Injection-site AE | 302 Participants |
| PREVNAR 13® | Number of Participants With an Injection-site AE | 304 Participants |
Primary
Number of Participants With a Serious Adverse Event (SAE)
An SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.
Time frame: Up to one month after last dose of study vaccine
Population: The analysis population included all randomized participants who received at least one dose of study vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| V114 Adjuvanted | Number of Participants With a Serious Adverse Event (SAE) | 25 Participants |
| V114 Nonadjuvanted | Number of Participants With a Serious Adverse Event (SAE) | 27 Participants |
| PREVNAR 13® | Number of Participants With a Serious Adverse Event (SAE) | 29 Participants |
Primary
Number of Participants With a Systemic AE
Systemic AEs reported by \> 0% of participants in one or more vaccination groups were assessed.
Time frame: Up to Day 14 postvaccination
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| V114 Adjuvanted | Number of Participants With a Systemic AE | 342 Participants |
| V114 Nonadjuvanted | Number of Participants With a Systemic AE | 352 Participants |
| PREVNAR 13® | Number of Participants With a Systemic AE | 347 Participants |
Primary
Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3
Percentage of participants meeting the serotype-specific IgG reference level (an antibody concentration measured by the pneumococcal polysaccharide electrochemiluminescence \[Pn ECL\] assay corresponding to the World Health Organization enzyme-linked immunosorbent assay \[WHO ELISA\] ≥ 0.35 μg/mL) (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
Time frame: One month postvaccination 3
Population: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 Adjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 19A | 82.7 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 3 | 93.3 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 6B | 73.7 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 6A | 77.0 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 14 | 98.7 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 7F | 99.0 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 23F | 87.7 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 4 | 97.0 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 9V | 95.0 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 19F | 91.3 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 33F (non-PREVNAR 13® serotype) | 83.3 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 22F (non-PREVNAR 13® serotype) | 99.0 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 1 | 98.0 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 18C | 96.7 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 5 | 95.7 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 18C | 89.8 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 19A | 84.4 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 5 | 92.4 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 19F | 91.1 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 3 | 89.8 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 22F (non-PREVNAR 13® serotype) | 99.4 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 23F | 81.6 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 33F (non-PREVNAR 13® serotype) | 84.8 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 6A | 78.4 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 6B | 65.4 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 7F | 99.4 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 9V | 92.4 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 4 | 94.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 14 | 98.4 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 1 | 96.2 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 33F (non-PREVNAR 13® serotype) | 1.0 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 23F | 90.8 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 1 | 97.5 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 3 | 69.2 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 4 | 96.5 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 5 | 96.2 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 6A | 96.8 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 6B | 87.6 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 7F | 99.4 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 9V | 97.5 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 14 | 97.8 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 18C | 97.5 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 19A | 96.5 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 19F | 99.4 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific ≥0.35 μg/mLThreshold Value for Postvaccination 3 | Serotype 22F (non-PREVNAR 13® serotype) | 1.9 Percentage of Participants |
Secondary
OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3
The antibody responses as measured by MOPA4 (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. The OPA antibody responses included the percentage of participants with OPA titer and the GMTs. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses.
Time frame: One month postvaccination 3
Population: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 Adjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 14 | 2266.2 μg/mL |
| V114 Adjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 18C | 1263.7 μg/mL |
| V114 Adjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 6A | 1273.6 μg/mL |
| V114 Adjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 19A | 551.7 μg/mL |
| V114 Adjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 6B | 765.5 μg/mL |
| V114 Adjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 23F | 1087.7 μg/mL |
| V114 Adjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 22F (non-PREVNAR 13® serotype) | 3048.8 μg/mL |
| V114 Adjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 1 | 35.4 μg/mL |
| V114 Adjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 33F (non-PREVNAR 13® serotype) | 25075.2 μg/mL |
| V114 Adjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 4 | 1672.9 μg/mL |
| V114 Adjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 7F | 5818.1 μg/mL |
| V114 Adjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 9V | 2227.4 μg/mL |
| V114 Adjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 3 | 296.7 μg/mL |
| V114 Adjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 19F | 986.2 μg/mL |
| V114 Adjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 5 | 467.6 μg/mL |
| V114 Nonadjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 7F | 5791.3 μg/mL |
| V114 Nonadjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 3 | 254.3 μg/mL |
| V114 Nonadjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 33F (non-PREVNAR 13® serotype) | 28262.3 μg/mL |
| V114 Nonadjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 18C | 846.6 μg/mL |
| V114 Nonadjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 1 | 32.4 μg/mL |
| V114 Nonadjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 6A | 703.3 μg/mL |
| V114 Nonadjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 19A | 457.9 μg/mL |
| V114 Nonadjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 19F | 933.7 μg/mL |
| V114 Nonadjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 9V | 1927.3 μg/mL |
| V114 Nonadjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 22F (non-PREVNAR 13® serotype) | 2714.4 μg/mL |
| V114 Nonadjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 14 | 1574.8 μg/mL |
| V114 Nonadjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 6B | 419.5 μg/mL |
| V114 Nonadjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 23F | 726.4 μg/mL |
| V114 Nonadjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 4 | 1633.1 μg/mL |
| V114 Nonadjuvanted | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 5 | 337.0 μg/mL |
| PREVNAR 13® | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 33F (non-PREVNAR 13® serotype) | 66.6 μg/mL |
| PREVNAR 13® | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 3 | 209.9 μg/mL |
| PREVNAR 13® | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 4 | 1911.6 μg/mL |
| PREVNAR 13® | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 1 | 44.6 μg/mL |
| PREVNAR 13® | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 5 | 542.8 μg/mL |
| PREVNAR 13® | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 6A | 4009.7 μg/mL |
| PREVNAR 13® | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 6B | 1597.5 μg/mL |
| PREVNAR 13® | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 19A | 1292.1 μg/mL |
| PREVNAR 13® | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 7F | 10454.1 μg/mL |
| PREVNAR 13® | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 9V | 2685.5 μg/mL |
| PREVNAR 13® | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 14 | 2786.5 μg/mL |
| PREVNAR 13® | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 18C | 2209.0 μg/mL |
| PREVNAR 13® | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 19F | 1417.1 μg/mL |
| PREVNAR 13® | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 22F (non-PREVNAR 13® serotype) | 3.9 μg/mL |
| PREVNAR 13® | OPA Geometric Mean Titers (GMTs) as Measured by MOPA4 for Postvaccination 3 | Serotype 23F | 3040.3 μg/mL |
Secondary
OPA GMTs as Measured by MOPA4 for Postvaccination 4
The antibody responses as measured by MOPA4 (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses.
Time frame: One month postvaccination 4
Population: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 Adjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 6A | 2583.6 μg/mL |
| V114 Adjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 3 | 438.6 μg/mL |
| V114 Adjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 19A | 1871.0 μg/mL |
| V114 Adjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 6B | 3866.8 μg/mL |
| V114 Adjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 1 | 139.1 μg/mL |
| V114 Adjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 18C | 1327.0 μg/mL |
| V114 Adjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 7F | 10205.9 μg/mL |
| V114 Adjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 9V | 2888.0 μg/mL |
| V114 Adjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 14 | 3543.1 μg/mL |
| V114 Adjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 4 | 1674.3 μg/mL |
| V114 Adjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 33F (non-PREVNAR 13® serotype) | 59179.6 μg/mL |
| V114 Adjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 22F (non-PREVNAR 13® serotype) | 4586.5 μg/mL |
| V114 Adjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 5 | 680.8 μg/mL |
| V114 Adjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 23F | 3118.0 μg/mL |
| V114 Adjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 19F | 1885.8 μg/mL |
| V114 Nonadjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 22F (non-PREVNAR 13® serotype) | 4497.0 μg/mL |
| V114 Nonadjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 33F (non-PREVNAR 13® serotype) | 54562.2 μg/mL |
| V114 Nonadjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 1 | 124.0 μg/mL |
| V114 Nonadjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 3 | 405.2 μg/mL |
| V114 Nonadjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 4 | 1752.9 μg/mL |
| V114 Nonadjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 5 | 866.5 μg/mL |
| V114 Nonadjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 6A | 2835.9 μg/mL |
| V114 Nonadjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 6B | 2265.1 μg/mL |
| V114 Nonadjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 7F | 8543.2 μg/mL |
| V114 Nonadjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 9V | 3339.1 μg/mL |
| V114 Nonadjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 14 | 2877.7 μg/mL |
| V114 Nonadjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 18C | 1171.1 μg/mL |
| V114 Nonadjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 19A | 2260.8 μg/mL |
| V114 Nonadjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 19F | 2949.8 μg/mL |
| V114 Nonadjuvanted | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 23F | 2469.2 μg/mL |
| PREVNAR 13® | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 1 | 133.1 μg/mL |
| PREVNAR 13® | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 18C | 3214.7 μg/mL |
| PREVNAR 13® | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 6A | 7382.0 μg/mL |
| PREVNAR 13® | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 33F (non-PREVNAR 13® serotype) | 815.8 μg/mL |
| PREVNAR 13® | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 19A | 4519.7 μg/mL |
| PREVNAR 13® | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 5 | 830.3 μg/mL |
| PREVNAR 13® | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 23F | 11490.0 μg/mL |
| PREVNAR 13® | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 19F | 2624.6 μg/mL |
| PREVNAR 13® | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 4 | 2456.5 μg/mL |
| PREVNAR 13® | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 3 | 369.7 μg/mL |
| PREVNAR 13® | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 9V | 4901.5 μg/mL |
| PREVNAR 13® | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 7F | 19147.5 μg/mL |
| PREVNAR 13® | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 22F (non-PREVNAR 13® serotype) | 4.8 μg/mL |
| PREVNAR 13® | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 14 | 3872.9 μg/mL |
| PREVNAR 13® | OPA GMTs as Measured by MOPA4 for Postvaccination 4 | Serotype 6B | 4686.1 μg/mL |
Secondary
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4
Percentage of participants achieving World Health Organization (WHO) predefined antibody threshold as measured by the pneumococcal polysaccharide electrochemiluminescence (Pn ECL) assay corresponding to the WHO enzyme-linked immunosorbent assay (ELISA) value of ≥ 0.35μg/mL (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
Time frame: One month postvaccination 4
Population: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 9V | 98.9 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 5 | 99.3 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 19F | 99.3 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 7F | 100.0 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 6A | 98.5 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 33F (non-PREVNAR 13® serotype) | 98.9 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 6B | 99.3 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 18C | 98.5 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 1 | 98.2 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 23F | 95.6 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 19A | 97.5 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 3 | 96.0 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 14 | 99.6 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 4 | 95.6 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 22F (non-PREVNAR 13® serotype) | 100.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 5 | 99.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 19F | 99.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 22F (non-PREVNAR 13® serotype) | 99.7 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 1 | 98.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 4 | 96.3 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 3 | 95.9 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 6A | 97.3 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 6B | 97.7 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 7F | 99.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 9V | 99.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 14 | 99.7 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 18C | 99.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 19A | 98.7 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 23F | 95.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 33F (non-PREVNAR 13® serotype) | 98.3 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 9V | 99.6 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 3 | 80.9 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 33F (non-PREVNAR 13® serotype) | 4.9 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 23F | 98.9 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 1 | 100.0 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 14 | 100.0 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 19F | 99.3 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 6A | 99.6 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 19A | 100.0 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 6B | 98.9 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 5 | 98.9 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 22F (non-PREVNAR 13® serotype) | 7.4 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 7F | 99.6 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 4 | 96.8 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥0.35 μg/mL for Postvaccination 4 | Serotype 18C | 100.0 Percentage of Participants |
Secondary
Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4
Percentage of participants achieving WHO predefined antibody threshold as measured by the Pn ECL assay corresponding to the WHO enzyme-linked immunosorbent assay (ELISA) value of ≥ 1.0 μg/mL (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®.
Time frame: One month postvaccination 4
Population: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 4 | 62.0 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 7F | 96.4 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 18C | 83.6 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 5 | 79.6 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 22F (non-PREVNAR 13® serotype) | 99.6 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 14 | 95.3 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 6B | 97.1 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 23F | 76.4 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 9V | 88.6 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 1 | 77.5 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 33F (non-PREVNAR 13® serotype) | 96.0 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 19F | 95.3 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 3 | 63.6 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 6A | 89.8 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 19A | 87.6 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 19A | 87.9 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 6A | 89.2 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 9V | 87.9 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 22F (non-PREVNAR 13® serotype) | 98.7 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 1 | 76.5 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 3 | 56.8 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 4 | 65.1 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 5 | 75.8 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 6B | 92.6 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 7F | 97.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 14 | 97.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 18C | 74.5 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 19F | 97.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 23F | 70.5 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 33F (non-PREVNAR 13® serotype) | 96.6 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 4 | 73.3 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 23F | 86.4 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 18C | 95.0 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 3 | 30.9 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 5 | 85.1 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 19A | 96.4 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 1 | 84.1 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 7F | 99.3 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 19F | 95.7 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 22F (non-PREVNAR 13® serotype) | 2.8 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 6B | 95.4 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 9V | 91.5 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 6A | 97.5 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 33F (non-PREVNAR 13® serotype) | 1.4 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants Achieving the IgG Serotype-specific Threshold Value of ≥1.0 μg/mL for Postvaccination 4 | Serotype 14 | 98.2 Percentage of Participants |
Secondary
Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4
The antibody responses as measured by MOPA4 (post-dose 4) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses.
Time frame: One month postvaccination 4
Population: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 Adjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 4 | 98.3 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 22F (non-PREVNAR 13® serotype) | 100.0 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 9V | 98.3 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 3 | 100.0 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 23F | 100.0 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 5 | 98.3 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 1 | 96.6 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 33F (non-PREVNAR 13® serotype) | 100.0 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 6B | 98.3 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 18C | 98.3 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 7F | 100.0 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 19A | 98.3 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 6A | 98.3 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 19F | 96.6 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 14 | 100.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 4 | 100.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 7F | 100.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 9V | 100.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 14 | 100.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 18C | 100.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 19A | 98.3 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 19F | 100.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 22F (non-PREVNAR 13® serotype) | 100.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 23F | 100.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 33F (non-PREVNAR 13® serotype) | 100.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 1 | 94.9 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 3 | 100.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 5 | 100.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 6A | 100.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 6B | 100.0 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 22F (non-PREVNAR 13® serotype) | 17.0 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 6A | 100.0 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 3 | 100.0 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 19F | 100.0 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 18C | 100.0 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 4 | 100.0 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 14 | 100.0 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 7F | 100.0 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 5 | 100.0 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 9V | 100.0 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 33F (non-PREVNAR 13® serotype) | 88.0 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 19A | 100.0 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 23F | 100.0 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 6B | 100.0 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With OPA Titer ≥ 8 as Measured by MOPA4 for Postvaccination 4 | Serotype 1 | 96.0 Percentage of Participants |
Secondary
Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3
The antibody responses as measured by MOPA4 (post-dose 3) for the 13 serotypes in common with PREVNAR 13® (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and the 2 serotypes (serotypes 22F and 33F) not in common with PREVNAR 13®. Functional antibody activity was assessed only in a subset of the vaccinated participants, thus the study was not powered for assessing non-inferiority with respect to the OPA antibody responses.
Time frame: One month postvaccination 3
Population: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 Adjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 3 | 99.2 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 18C | 99.2 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 6B | 84.0 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 1 | 80.0 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 14 | 100.0 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 7F | 100.0 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 22F (non-PREVNAR 13® serotype) | 99.2 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 9V | 100.0 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 4 | 100.0 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 23F | 97.5 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 19F | 95.0 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 5 | 99.2 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 33F (non-PREVNAR 13® serotype) | 97.5 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 19A | 92.5 Percentage of Participants |
| V114 Adjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 6A | 89.2 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 33F (non-PREVNAR 13® serotype) | 99.2 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 1 | 73.3 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 3 | 100.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 4 | 100.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 5 | 95.8 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 6A | 85.8 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 6B | 80.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 7F | 100.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 9V | 98.3 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 14 | 99.2 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 18C | 96.7 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 19A | 95.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 19F | 95.8 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 22F (non-PREVNAR 13® serotype) | 100.0 Percentage of Participants |
| V114 Nonadjuvanted | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 23F | 96.6 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 22F (non-PREVNAR 13® serotype) | 11.6 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 18C | 100.0 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 5 | 97.5 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 33F (non-PREVNAR 13® serotype) | 60.7 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 19A | 95.9 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 4 | 100.0 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 23F | 96.7 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 19F | 99.2 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 7F | 100.0 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 3 | 100.0 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 9V | 99.2 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 6B | 96.7 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 1 | 77.7 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 14 | 100.0 Percentage of Participants |
| PREVNAR 13® | Percentage of Participants With Opsonophagocytic Killing Activity (OPA) Titer ≥ 8 as Measured by Fourfold Multiplexed Opsonization Assay (MOPA4) for Postvaccination 3 | Serotype 6A | 100.0 Percentage of Participants |