Pneumonia, Pneumococcal
Conditions
Brief summary
This a study of V116 in adults ≥50 years of age who previously received a pneumococcal vaccination ≥1 year before enrollment. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116.
Detailed description
Participants will be randomized to 1 of 3 cohorts depending upon prior vaccinations. Prior vaccinations by cohort include: PPSV23 (pneumococcal vaccine, polyvalent \[23-valent\], PNEUMOVAX™23) for Cohort 1; PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) for Cohort 2; PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™), PCV20 (pneumococcal 20-valent conjugate vaccine; PREVNAR 20™), PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 for Cohort 3.
Interventions
BIOLOGICALV116
Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
BIOLOGICALPCV15
Pneumococcal 15-valent conjugate vaccine with 2 μg of each of the PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F, and 4 μg of 6B in each 0.5 mL sterile suspension
BIOLOGICALPPSV23
Pneumococcal 23-valent vaccine with 25 μg of each of the PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Cohorts 1 and 2: participants, investigator, sponsor Cohort 3: no blinding
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
The main inclusion and
Exclusion criteria
include but are not limited to the following: Inclusion Criteria: * Has received pneumococcal vaccine \>= 1 year before enrollment (PCV13, PCV15, PCV20, PPSV23, PCV13+PPSV23, PPSV23+PCV13, or PCV15+PPSV23).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Up to 5 days post-vaccination | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any injection with either V116, PCV15, or PPSV23 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were erythema, pain, and swelling. |
| Percentage of Participants With Solicited Systemic AEs | Up to 5 days post-vaccination | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any of the injections with either V116, PCV15, or PPSV23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia. |
| Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) | Up to ~180 days | 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. The percentage of participants with one or more SAE that were assessed by the investigator to be at least possibly related to the study vaccination are presented. |
| Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | 30 Days post-vaccination | OPA for the serotypes contained in V116 were determined using a multiplex opsonophagocytic assay (MOPA). GMT is defined as geometric mean titer (1/dil). Serotype-specific OPA GMTs with 95% confidence intervals are presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | 30 Days post-vaccination | The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in V116 was determined using a pneumococcal electrochemiluminescence (PnECL) assay. Serotype-specific pneumococcal IgG GMCs with 95% confidence intervals are presented. |
| Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Day 1 (Baseline) and 30 days post-vaccination | Activity for the serotypes contained in V116 was determined using a PnECL assay. The percentage of participants with a ≥4-fold rise from baseline to at 30 days post-vaccination for IgG responses with 95% confidence intervals are presented. |
| Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Day 1 (Baseline) and 30 days post-vaccination | Activity for the serotypes contained in V116 was determined using a multiplex opsonophagocytic assay (MOPA). 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. The GMFRs in OPA responses from baseline to 30 days post-vaccination with 95% confidence intervals are presented. |
| Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Day 1 (Baseline) and 30 days post-vaccination | Activity for the serotypes contained in V116 was determined using a MOPA. The percentage of participants with a ≥4-fold rise from baseline to at 30 days post-vaccination for OPA responses with 95% confidence intervals are presented. |
| Geometric Mean Fold Rise of Serotype-specific IgG | Day 1 (Baseline) and 30 days post-vaccination | Activity for the serotypes contained in V116 was determined using a PnECL 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. The GMFRs IgG responses from baseline to 30 days post-vaccination with 95% confidence intervals are presented. |
Countries
Canada, France, Israel, Italy, Japan, South Korea, Spain, Taiwan, United States
Participant flow
Pre-assignment details
717 adults were randomized to 1 of 3 cohorts. One participant randomized to receive PCV15 in Cohort 1 incorrectly received V116. Per protocol the participant was included in the Cohort 1 V116 group. One participant randomized to receive PCV15 in Cohort 1 incorrectly received PPSV23 (intervention for Cohort 2). Per protocol this participant was excluded from the all participants as treated population because the actual intervention received was not 1 of the 2 designated interventions in Cohort 1.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: V116 Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent \[23-valent\], PNEUMOVAX™23) prior to the enrollment. | 231 |
| Cohort 1: PCV15 Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment. | 119 |
| Cohort 2: V116 Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment. | 176 |
| Cohort 2: PPSV23 Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment. | 85 |
| Cohort 3: V116 Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment. | 106 |
| Total | 717 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Randomized by mistake without study treatment | 0 | 0 | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Cohort 1: V116 | Cohort 1: PCV15 | Cohort 2: V116 | Cohort 2: PPSV23 | Cohort 3: V116 | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 68.8 Years STANDARD_DEVIATION 7.5 | 69.0 Years STANDARD_DEVIATION 7.1 | 65.4 Years STANDARD_DEVIATION 7.8 | 65.4 Years STANDARD_DEVIATION 6.6 | 71.0 Years STANDARD_DEVIATION 7.6 | 67.9 Years STANDARD_DEVIATION 7.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants | 17 Participants | 34 Participants | 16 Participants | 14 Participants | 103 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 207 Participants | 102 Participants | 142 Participants | 69 Participants | 92 Participants | 612 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 96 Participants | 47 Participants | 55 Participants | 25 Participants | 13 Participants | 236 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 3 Participants | 3 Participants | 1 Participants | 6 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 127 Participants | 69 Participants | 118 Participants | 59 Participants | 86 Participants | 459 Participants |
| Sex: Female, Male Female | 117 Participants | 60 Participants | 101 Participants | 49 Participants | 56 Participants | 383 Participants |
| Sex: Female, Male Male | 114 Participants | 59 Participants | 75 Participants | 36 Participants | 50 Participants | 334 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 231 | 0 / 119 | 0 / 176 | 0 / 85 | 0 / 106 |
| other Total, other adverse events | 107 / 230 | 66 / 117 | 85 / 174 | 52 / 85 | 51 / 105 |
| serious Total, serious adverse events | 2 / 230 | 4 / 117 | 2 / 174 | 3 / 85 | 2 / 105 |
Outcome results
Primary
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)
OPA for the serotypes contained in V116 were determined using a multiplex opsonophagocytic assay (MOPA). GMT is defined as geometric mean titer (1/dil). Serotype-specific OPA GMTs with 95% confidence intervals are presented.
Time frame: 30 Days post-vaccination
Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 3 | 262.1 Titers |
| Cohort 1: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6A | 1653.5 Titers |
| Cohort 1: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 7F | 2184.4 Titers |
| Cohort 1: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 23A | 2363.9 Titers |
| Cohort 1: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 33F | 4311.9 Titers |
| Cohort 1: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 11A | 1998.5 Titers |
| Cohort 1: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 15A | 4184.9 Titers |
| Cohort 1: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 24F | 1822.6 Titers |
| Cohort 1: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 20A | 2847.4 Titers |
| Cohort 1: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 8 | 1273.0 Titers |
| Cohort 1: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 19A | 1513.8 Titers |
| Cohort 1: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 12F | 981.8 Titers |
| Cohort 1: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 35B | 6703.1 Titers |
| Cohort 1: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 17F | 3599.8 Titers |
| Cohort 1: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 9N | 3805.1 Titers |
| Cohort 1: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 15C | 2307.8 Titers |
| Cohort 1: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 23B | 673.2 Titers |
| Cohort 1: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 22F | 1983.8 Titers |
| Cohort 1: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 16F | 3060.5 Titers |
| Cohort 1: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 10A | 1986.2 Titers |
| Cohort 1: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 31 | 3018.4 Titers |
| Cohort 1: PCV15 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 10A | 467.5 Titers |
| Cohort 1: PCV15 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 15C | 539.6 Titers |
| Cohort 1: PCV15 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 11A | 335.6 Titers |
| Cohort 1: PCV15 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 15A | 877.2 Titers |
| Cohort 1: PCV15 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 12F | 80.5 Titers |
| Cohort 1: PCV15 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 7F | 1750.3 Titers |
| Cohort 1: PCV15 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 35B | 1019.1 Titers |
| Cohort 1: PCV15 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 24F | 106.6 Titers |
| Cohort 1: PCV15 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 19A | 2022.9 Titers |
| Cohort 1: PCV15 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 23B | 153.0 Titers |
| Cohort 1: PCV15 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 22F | 1595.6 Titers |
| Cohort 1: PCV15 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 23A | 310.2 Titers |
| Cohort 1: PCV15 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 33F | 3397.2 Titers |
| Cohort 1: PCV15 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6A | 2076.1 Titers |
| Cohort 1: PCV15 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 20A | 1058.9 Titers |
| Cohort 1: PCV15 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 8 | 345.8 Titers |
| Cohort 1: PCV15 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 3 | 226.3 Titers |
| Cohort 1: PCV15 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 17F | 939.6 Titers |
| Cohort 1: PCV15 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 9N | 2176.5 Titers |
| Cohort 1: PCV15 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 31 | 113.2 Titers |
| Cohort 1: PCV15 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 16F | 392.3 Titers |
| Cohort 2: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 12F | 2252.6 Titers |
| Cohort 2: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 3 | 391.1 Titers |
| Cohort 2: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6A | 3624.0 Titers |
| Cohort 2: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 7F | 3129.8 Titers |
| Cohort 2: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 19A | 2528.9 Titers |
| Cohort 2: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 22F | 4389.2 Titers |
| Cohort 2: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 33F | 8162.9 Titers |
| Cohort 2: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 8 | 2320.1 Titers |
| Cohort 2: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 9N | 7214.4 Titers |
| Cohort 2: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 10A | 3976.8 Titers |
| Cohort 2: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 11A | 2846.6 Titers |
| Cohort 2: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 15A | 6185.2 Titers |
| Cohort 2: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 15C | 4334.4 Titers |
| Cohort 2: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 16F | 4626.5 Titers |
| Cohort 2: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 17F | 5963.8 Titers |
| Cohort 2: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 20A | 6005.5 Titers |
| Cohort 2: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 23A | 4253.4 Titers |
| Cohort 2: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 23B | 1530.7 Titers |
| Cohort 2: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 24F | 2746.1 Titers |
| Cohort 2: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 31 | 4413.5 Titers |
| Cohort 2: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 35B | 8143.5 Titers |
| Cohort 2: PPSV23 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 16F | 832.8 Titers |
| Cohort 2: PPSV23 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 9N | 6482.5 Titers |
| Cohort 2: PPSV23 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 19A | 3241.5 Titers |
| Cohort 2: PPSV23 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 3 | 583.1 Titers |
| Cohort 2: PPSV23 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 23B | 203.9 Titers |
| Cohort 2: PPSV23 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 33F | 8761.9 Titers |
| Cohort 2: PPSV23 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 35B | 1527.7 Titers |
| Cohort 2: PPSV23 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 7F | 4057.0 Titers |
| Cohort 2: PPSV23 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 20A | 3393.9 Titers |
| Cohort 2: PPSV23 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 24F | 48.5 Titers |
| Cohort 2: PPSV23 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 8 | 2723.2 Titers |
| Cohort 2: PPSV23 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 12F | 1402.5 Titers |
| Cohort 2: PPSV23 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 31 | 171.8 Titers |
| Cohort 2: PPSV23 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 22F | 2524.0 Titers |
| Cohort 2: PPSV23 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 11A | 1736.6 Titers |
| Cohort 2: PPSV23 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 15C | 1470.4 Titers |
| Cohort 2: PPSV23 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 15A | 1668.2 Titers |
| Cohort 2: PPSV23 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 17F | 4367.3 Titers |
| Cohort 2: PPSV23 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 23A | 433.6 Titers |
| Cohort 2: PPSV23 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 10A | 1797.6 Titers |
| Cohort 2: PPSV23 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6A | 1812.3 Titers |
| Cohort 3: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6A | 2097.3 Titers |
| Cohort 3: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 15C | 2191.9 Titers |
| Cohort 3: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 9N | 4054.5 Titers |
| Cohort 3: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 16F | 2477.0 Titers |
| Cohort 3: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 8 | 1486.8 Titers |
| Cohort 3: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 17F | 3836.7 Titers |
| Cohort 3: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 33F | 4654.3 Titers |
| Cohort 3: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 31 | 3285.5 Titers |
| Cohort 3: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 20A | 2433.4 Titers |
| Cohort 3: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 22F | 1913.5 Titers |
| Cohort 3: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 3 | 318.3 Titers |
| Cohort 3: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 23A | 3967.2 Titers |
| Cohort 3: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 19A | 1533.8 Titers |
| Cohort 3: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 23B | 844.0 Titers |
| Cohort 3: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 7F | 2051.3 Titers |
| Cohort 3: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 35B | 5836.8 Titers |
| Cohort 3: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 24F | 2041.5 Titers |
| Cohort 3: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 12F | 1235.3 Titers |
| Cohort 3: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 11A | 2373.0 Titers |
| Cohort 3: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 15A | 4328.6 Titers |
| Cohort 3: V116 | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 10A | 2564.0 Titers |
Primary
Percentage of Participants With Solicited Injection-site Adverse Events (AEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any injection with either V116, PCV15, or PPSV23 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were erythema, pain, and swelling.
Time frame: Up to 5 days post-vaccination
Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: V116 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Injection site erythema | 7.4 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Injection site swelling | 8.3 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Injection site pain | 35.7 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Injection site pain | 43.6 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Injection site erythema | 7.7 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Injection site swelling | 8.5 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Injection site pain | 41.4 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Injection site erythema | 7.5 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Injection site swelling | 4.6 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Injection site erythema | 9.4 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Injection site swelling | 16.5 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Injection site pain | 47.1 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Injection site pain | 43.8 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Injection site erythema | 7.6 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | Injection site swelling | 10.5 Percentage of Participants |
Primary
Percentage of Participants With Solicited Systemic AEs
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any of the injections with either V116, PCV15, or PPSV23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia.
Time frame: Up to 5 days post-vaccination
Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: V116 | Percentage of Participants With Solicited Systemic AEs | Headache | 7.0 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants With Solicited Systemic AEs | Fatigue | 14.3 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants With Solicited Systemic AEs | Pyrexia | 1.7 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants With Solicited Systemic AEs | Myalgia | 7.4 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants With Solicited Systemic AEs | Myalgia | 2.6 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants With Solicited Systemic AEs | Pyrexia | 2.6 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants With Solicited Systemic AEs | Headache | 9.4 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants With Solicited Systemic AEs | Fatigue | 17.1 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants With Solicited Systemic AEs | Pyrexia | 2.9 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants With Solicited Systemic AEs | Fatigue | 19.0 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants With Solicited Systemic AEs | Headache | 10.3 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants With Solicited Systemic AEs | Myalgia | 9.8 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants With Solicited Systemic AEs | Fatigue | 12.9 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants With Solicited Systemic AEs | Myalgia | 9.4 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants With Solicited Systemic AEs | Pyrexia | 1.2 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants With Solicited Systemic AEs | Headache | 11.8 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants With Solicited Systemic AEs | Myalgia | 8.6 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants With Solicited Systemic AEs | Fatigue | 21.9 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants With Solicited Systemic AEs | Headache | 8.6 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants With Solicited Systemic AEs | Pyrexia | 0.0 Percentage of Participants |
Primary
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)
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. The percentage of participants with one or more SAE that were assessed by the investigator to be at least possibly related to the study vaccination are presented.
Time frame: Up to ~180 days
Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: V116 | Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) | 0.4 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) | 0.0 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) | 0.0 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) | 0.0 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) | 0.0 Percentage of Participants |
Secondary
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in V116 was determined using a pneumococcal electrochemiluminescence (PnECL) assay. Serotype-specific pneumococcal IgG GMCs with 95% confidence intervals are presented.
Time frame: 30 Days post-vaccination
Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 31 | 4.48 μg/mL |
| Cohort 1: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 35B | 26.31 μg/mL |
| Cohort 1: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 11A | 7.16 μg/mL |
| Cohort 1: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 23A | 5.38 μg/mL |
| Cohort 1: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 33F | 13.36 μg/mL |
| Cohort 1: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 15A | 16.35 μg/mL |
| Cohort 1: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 6A | 4.69 μg/mL |
| Cohort 1: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 24F | 10.05 μg/mL |
| Cohort 1: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 20A | 14.83 μg/mL |
| Cohort 1: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 8 | 9.58 μg/mL |
| Cohort 1: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 19A | 8.54 μg/mL |
| Cohort 1: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 12F | 1.46 μg/mL |
| Cohort 1: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 15C | 11.08 μg/mL |
| Cohort 1: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 17F | 13.20 μg/mL |
| Cohort 1: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 9N | 7.06 μg/mL |
| Cohort 1: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 7F | 5.71 μg/mL |
| Cohort 1: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 3 | 0.87 μg/mL |
| Cohort 1: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 23B | 6.66 μg/mL |
| Cohort 1: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 16F | 4.69 μg/mL |
| Cohort 1: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 10A | 9.86 μg/mL |
| Cohort 1: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 22F | 4.41 μg/mL |
| Cohort 1: PCV15 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 10A | 2.77 μg/mL |
| Cohort 1: PCV15 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 15C | 3.25 μg/mL |
| Cohort 1: PCV15 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 11A | 2.06 μg/mL |
| Cohort 1: PCV15 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 15A | 1.56 μg/mL |
| Cohort 1: PCV15 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 12F | 0.41 μg/mL |
| Cohort 1: PCV15 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 7F | 6.45 μg/mL |
| Cohort 1: PCV15 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 3 | 0.80 μg/mL |
| Cohort 1: PCV15 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 24F | 0.49 μg/mL |
| Cohort 1: PCV15 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 19A | 11.97 μg/mL |
| Cohort 1: PCV15 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 35B | 1.45 μg/mL |
| Cohort 1: PCV15 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 23B | 2.61 μg/mL |
| Cohort 1: PCV15 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 22F | 4.33 μg/mL |
| Cohort 1: PCV15 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 23A | 0.75 μg/mL |
| Cohort 1: PCV15 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 33F | 12.72 μg/mL |
| Cohort 1: PCV15 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 20A | 4.93 μg/mL |
| Cohort 1: PCV15 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 8 | 3.56 μg/mL |
| Cohort 1: PCV15 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 6A | 7.69 μg/mL |
| Cohort 1: PCV15 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 17F | 2.68 μg/mL |
| Cohort 1: PCV15 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 9N | 3.59 μg/mL |
| Cohort 1: PCV15 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 16F | 0.37 μg/mL |
| Cohort 1: PCV15 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 31 | 0.37 μg/mL |
| Cohort 2: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 3 | 0.89 μg/mL |
| Cohort 2: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 6A | 7.81 μg/mL |
| Cohort 2: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 7F | 5.65 μg/mL |
| Cohort 2: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 19A | 9.12 μg/mL |
| Cohort 2: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 22F | 5.38 μg/mL |
| Cohort 2: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 33F | 15.04 μg/mL |
| Cohort 2: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 8 | 11.29 μg/mL |
| Cohort 2: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 9N | 8.48 μg/mL |
| Cohort 2: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 10A | 18.21 μg/mL |
| Cohort 2: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 11A | 9.13 μg/mL |
| Cohort 2: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 12F | 1.91 μg/mL |
| Cohort 2: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 15A | 20.24 μg/mL |
| Cohort 2: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 15C | 16.67 μg/mL |
| Cohort 2: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 16F | 4.04 μg/mL |
| Cohort 2: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 17F | 14.96 μg/mL |
| Cohort 2: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 20A | 22.21 μg/mL |
| Cohort 2: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 23A | 6.03 μg/mL |
| Cohort 2: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 23B | 6.00 μg/mL |
| Cohort 2: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 24F | 7.48 μg/mL |
| Cohort 2: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 31 | 3.58 μg/mL |
| Cohort 2: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 35B | 24.55 μg/mL |
| Cohort 2: PPSV23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 17F | 7.23 μg/mL |
| Cohort 2: PPSV23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 35B | 1.45 μg/mL |
| Cohort 2: PPSV23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 19A | 12.41 μg/mL |
| Cohort 2: PPSV23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 3 | 1.58 μg/mL |
| Cohort 2: PPSV23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 23B | 2.31 μg/mL |
| Cohort 2: PPSV23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 16F | 0.30 μg/mL |
| Cohort 2: PPSV23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 33F | 13.92 μg/mL |
| Cohort 2: PPSV23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 7F | 8.34 μg/mL |
| Cohort 2: PPSV23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 15C | 4.31 μg/mL |
| Cohort 2: PPSV23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 24F | 0.31 μg/mL |
| Cohort 2: PPSV23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 20A | 10.73 μg/mL |
| Cohort 2: PPSV23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 12F | 1.01 μg/mL |
| Cohort 2: PPSV23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 9N | 7.32 μg/mL |
| Cohort 2: PPSV23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 8 | 14.47 μg/mL |
| Cohort 2: PPSV23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 11A | 3.95 μg/mL |
| Cohort 2: PPSV23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 6A | 5.24 μg/mL |
| Cohort 2: PPSV23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 22F | 2.87 μg/mL |
| Cohort 2: PPSV23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 15A | 2.15 μg/mL |
| Cohort 2: PPSV23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 31 | 0.32 μg/mL |
| Cohort 2: PPSV23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 23A | 0.62 μg/mL |
| Cohort 2: PPSV23 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 10A | 7.29 μg/mL |
| Cohort 3: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 15C | 6.51 μg/mL |
| Cohort 3: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 9N | 4.15 μg/mL |
| Cohort 3: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 16F | 2.46 μg/mL |
| Cohort 3: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 8 | 7.48 μg/mL |
| Cohort 3: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 17F | 9.92 μg/mL |
| Cohort 3: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 33F | 9.66 μg/mL |
| Cohort 3: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 31 | 3.66 μg/mL |
| Cohort 3: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 20A | 12.16 μg/mL |
| Cohort 3: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 22F | 3.08 μg/mL |
| Cohort 3: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 3 | 0.85 μg/mL |
| Cohort 3: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 23A | 4.25 μg/mL |
| Cohort 3: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 19A | 8.06 μg/mL |
| Cohort 3: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 23B | 5.05 μg/mL |
| Cohort 3: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 7F | 5.07 μg/mL |
| Cohort 3: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 35B | 18.15 μg/mL |
| Cohort 3: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 24F | 6.12 μg/mL |
| Cohort 3: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 12F | 0.96 μg/mL |
| Cohort 3: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 11A | 4.78 μg/mL |
| Cohort 3: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 6A | 5.48 μg/mL |
| Cohort 3: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 15A | 11.16 μg/mL |
| Cohort 3: V116 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | Serotype 10A | 10.03 μg/mL |
Secondary
Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)
Activity for the serotypes contained in V116 was determined using a multiplex opsonophagocytic assay (MOPA). 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. The GMFRs in OPA responses from baseline to 30 days post-vaccination with 95% confidence intervals are presented.
Time frame: Day 1 (Baseline) and 30 days post-vaccination
Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 10A | 4.3 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 22F | 7.0 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 17F | 3.7 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 9N | 2.3 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 3 | 4.4 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 15C | 8.5 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 33F | 2.2 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 15A | 5.6 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 8 | 2.8 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 7F | 4.1 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 31 | 16.7 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 23A | 8.4 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 20A | 3.7 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 23B | 21.4 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 12F | 11.8 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 35B | 6.0 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6A | 6.2 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 11A | 6.5 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 24F | 25.8 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 19A | 2.4 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 16F | 7.1 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6A | 7.1 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 16F | 1.1 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 23A | 1.4 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 17F | 0.9 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 20A | 0.9 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 7F | 3.9 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 19A | 3.3 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 22F | 7.1 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 31 | 0.9 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 33F | 1.7 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 3 | 4.0 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 8 | 0.9 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 9N | 1.4 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 24F | 1.0 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 10A | 1.0 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 35B | 1.0 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 11A | 1.2 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 12F | 1.1 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 15C | 1.3 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 23B | 4.2 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 15A | 1.2 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 19A | 2.8 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 16F | 9.8 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 10A | 17.1 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 17F | 13.5 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 31 | 35.6 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 15C | 30.6 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 23A | 19.0 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 11A | 21.0 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 7F | 4.6 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 23B | 35.5 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 20A | 12.2 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 33F | 6.3 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 15A | 9.0 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 8 | 16.6 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 3 | 6.2 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 24F | 31.1 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 22F | 26.3 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 12F | 82.2 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 9N | 5.9 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 35B | 7.2 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6A | 4.2 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 20A | 6.0 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 3 | 7.5 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6A | 1.8 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 7F | 4.2 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 22F | 14.8 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 33F | 9.2 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 8 | 18.6 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 9N | 6.8 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 10A | 11.8 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 11A | 9.2 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 12F | 41.9 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 15A | 3.0 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 15C | 12.7 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 16F | 2.0 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 17F | 8.1 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 19A | 3.6 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 23A | 2.5 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 23B | 5.2 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 24F | 0.9 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 31 | 1.7 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 35B | 1.4 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 23A | 16.3 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 15A | 7.2 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 12F | 13.7 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 11A | 9.5 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 3 | 5.0 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 23B | 26.1 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 10A | 4.7 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 9N | 3.5 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 8 | 3.8 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 19A | 2.5 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 24F | 39.5 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 33F | 2.7 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 22F | 7.5 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 7F | 3.9 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 35B | 5.7 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 31 | 30.5 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 20A | 4.4 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 17F | 6.5 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 16F | 7.2 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 15C | 11.6 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6A | 5.5 Ratio |
Secondary
Geometric Mean Fold Rise of Serotype-specific IgG
Activity for the serotypes contained in V116 was determined using a PnECL 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. The GMFRs IgG responses from baseline to 30 days post-vaccination with 95% confidence intervals are presented.
Time frame: Day 1 (Baseline) and 30 days post-vaccination
Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 8 | 2.7 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 15C | 5.8 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 11A | 4.1 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 31 | 13.1 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 15A | 12.2 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 12F | 4.2 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 7F | 3.3 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 3 | 3.6 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 24F | 26.9 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 19A | 2.3 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 23B | 8.2 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 22F | 4.2 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 35B | 16.8 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 23A | 13.5 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 33F | 2.2 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 6A | 5.9 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 20A | 3.8 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 17F | 4.7 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 9N | 2.9 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 16F | 15.2 Ratio |
| Cohort 1: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 10A | 4.4 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 8 | 1.0 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 15C | 1.0 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 22F | 3.4 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 6A | 8.0 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 11A | 1.0 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 23A | 1.8 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 15A | 1.0 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 17F | 1.0 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 16F | 1.1 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 12F | 1.0 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 9N | 1.4 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 33F | 1.8 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 7F | 2.9 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 10A | 1.0 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 24F | 1.0 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 20A | 1.0 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 3 | 3.1 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 19A | 3.4 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 35B | 1.0 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 23B | 2.7 Ratio |
| Cohort 1: PCV15 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 31 | 1.1 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 12F | 14.2 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 3 | 3.7 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 6A | 3.3 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 7F | 3.2 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 19A | 2.2 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 22F | 14.3 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 33F | 8.6 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 8 | 12.1 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 9N | 8.7 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 10A | 18.9 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 11A | 10.3 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 15A | 24.5 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 15C | 18.8 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 16F | 15.7 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 17F | 17.4 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 20A | 14.8 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 23A | 18.9 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 23B | 7.3 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 24F | 21.7 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 31 | 14.4 Ratio |
| Cohort 2: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 35B | 15.6 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 16F | 1.6 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 9N | 9.1 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 19A | 3.0 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 3 | 5.7 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 23B | 2.3 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 33F | 10.5 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 35B | 0.9 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 7F | 3.2 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 20A | 8.5 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 24F | 1.0 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 8 | 14.4 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 12F | 8.4 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 31 | 1.5 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 22F | 8.5 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 11A | 5.6 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 15C | 6.2 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 15A | 2.4 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 17F | 10.5 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 23A | 2.3 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 10A | 10.1 Ratio |
| Cohort 2: PPSV23 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 6A | 2.5 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 6A | 4.4 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 15C | 6.4 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 9N | 3.2 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 16F | 11.9 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 8 | 2.3 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 17F | 3.8 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 33F | 2.4 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 31 | 13.0 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 20A | 3.7 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 22F | 3.5 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 3 | 2.9 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 23A | 13.1 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 19A | 2.0 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 23B | 7.3 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 7F | 3.2 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 35B | 15.7 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 24F | 24.4 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 12F | 3.5 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 11A | 3.5 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 15A | 16.6 Ratio |
| Cohort 3: V116 | Geometric Mean Fold Rise of Serotype-specific IgG | Serotype 10A | 4.2 Ratio |
Secondary
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response
Activity for the serotypes contained in V116 was determined using a PnECL assay. The percentage of participants with a ≥4-fold rise from baseline to at 30 days post-vaccination for IgG responses with 95% confidence intervals are presented.
Time frame: Day 1 (Baseline) and 30 days post-vaccination
Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 20A | 36.5 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 7F | 34.7 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 15A | 73.6 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 3 | 42.7 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 16F | 82.1 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 15C | 57.5 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 17F | 48.9 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 22F | 39.3 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 35B | 83.9 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 33F | 19.1 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 31 | 79.7 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 8 | 29.5 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 6A | 56.2 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 24F | 85.4 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 9N | 31.8 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 23B | 64.8 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 10A | 45.5 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 19A | 24.7 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 23A | 77.6 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 11A | 43.8 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 12F | 44.5 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 19A | 37.6 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 12F | 2.6 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 20A | 0.9 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 17F | 1.7 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 16F | 2.6 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 8 | 0.9 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 15A | 0.9 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 10A | 0.9 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 24F | 0.0 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 15C | 3.4 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 11A | 0.0 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 23A | 17.1 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 9N | 7.7 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 22F | 35.0 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 7F | 29.9 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 35B | 0.0 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 3 | 36.8 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 23B | 26.5 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 33F | 12.8 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 6A | 65.0 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 31 | 2.6 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 6A | 35.9 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 7F | 37.7 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 19A | 19.8 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 22F | 78.4 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 33F | 72.5 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 8 | 78.4 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 9N | 68.9 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 10A | 82.6 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 11A | 72.5 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 12F | 75.4 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 15A | 89.8 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 15C | 80.1 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 16F | 84.9 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 17F | 83.8 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 20A | 83.2 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 23A | 86.7 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 23B | 60.5 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 24F | 88.0 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 31 | 84.4 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 35B | 82.6 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 3 | 40.7 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 23A | 21.0 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 11A | 63.0 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 20A | 69.1 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 10A | 80.2 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 6A | 27.2 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 17F | 74.1 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 9N | 72.8 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 3 | 54.3 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 23B | 21.0 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 8 | 76.5 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 24F | 0.0 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 33F | 75.3 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 7F | 33.3 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 31 | 11.1 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 22F | 65.4 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 35B | 0.0 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 15C | 64.2 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 15A | 28.4 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 16F | 13.6 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 12F | 60.5 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 19A | 33.3 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 24F | 83.8 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 17F | 44.4 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 11A | 43.4 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 33F | 27.3 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 7F | 37.4 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 15A | 77.8 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 20A | 49.5 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 10A | 46.5 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 16F | 77.8 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 12F | 39.4 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 31 | 80.8 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 23A | 77.8 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 9N | 36.4 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 22F | 43.4 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 15C | 66.7 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 6A | 45.5 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 23B | 64.6 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 8 | 26.3 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 19A | 19.2 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 3 | 35.4 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response | Serotype 35B | 84.8 Percentage of Participants |
Secondary
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses
Activity for the serotypes contained in V116 was determined using a MOPA. The percentage of participants with a ≥4-fold rise from baseline to at 30 days post-vaccination for OPA responses with 95% confidence intervals are presented.
Time frame: Day 1 (Baseline) and 30 days post-vaccination
Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 12F | 62.8 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 10A | 46.0 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 31 | 70.9 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 15A | 53.5 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 11A | 53.8 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 15C | 61.4 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 6A | 57.9 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 35B | 55.2 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 24F | 80.2 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 7F | 38.5 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 23B | 74.9 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 19A | 28.4 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 23A | 59.9 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 22F | 53.9 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 17F | 37.7 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 20A | 37.5 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 33F | 19.8 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 3 | 54.9 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 8 | 33.3 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 16F | 68.0 Percentage of Participants |
| Cohort 1: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 9N | 22.0 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 17F | 2.0 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 15A | 12.8 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 19A | 34.6 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 10A | 2.7 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 16F | 8.0 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 35B | 7.5 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 12F | 6.3 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 22F | 54.9 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 11A | 12.1 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 24F | 7.7 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 8 | 2.8 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 20A | 2.9 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 6A | 58.6 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 3 | 54.9 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 9N | 6.5 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 23B | 40.4 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 33F | 19.4 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 7F | 43.1 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 31 | 8.2 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 15C | 10.2 Percentage of Participants |
| Cohort 1: PCV15 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 23A | 21.1 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 22F | 77.4 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 12F | 93.0 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 3 | 64.1 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 6A | 46.3 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 7F | 44.5 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 19A | 33.6 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 33F | 52.0 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 8 | 70.2 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 9N | 57.4 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 10A | 74.3 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 11A | 73.3 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 15A | 70.9 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 15C | 84.4 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 16F | 70.5 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 17F | 74.1 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 20A | 76.7 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 23A | 73.7 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 23B | 80.6 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 24F | 81.9 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 31 | 81.3 Percentage of Participants |
| Cohort 2: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 35B | 65.3 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 8 | 74.6 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 7F | 49.3 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 15C | 72.1 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 19A | 38.9 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 23B | 43.7 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 22F | 65.6 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 6A | 18.2 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 35B | 7.0 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 20A | 60.9 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 24F | 4.9 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 33F | 56.0 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 31 | 18.0 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 11A | 53.8 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 17F | 62.5 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 12F | 81.9 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 16F | 30.9 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 10A | 67.6 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 23A | 34.2 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 3 | 66.2 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 15A | 35.0 Percentage of Participants |
| Cohort 2: PPSV23 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 9N | 67.9 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 15A | 59.7 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 8 | 34.4 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 16F | 70.9 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 15C | 72.0 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 33F | 29.4 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 17F | 54.4 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 22F | 50.0 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 31 | 82.1 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 20A | 46.9 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 19A | 30.0 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 7F | 38.0 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 23A | 80.0 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 6A | 56.2 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 23B | 80.9 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 3 | 48.7 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 35B | 57.6 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 24F | 89.0 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 11A | 59.0 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 10A | 49.5 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 12F | 60.2 Percentage of Participants |
| Cohort 3: V116 | Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses | Serotype 9N | 39.1 Percentage of Participants |