Trial Outcomes & Findings for Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine (V116) in Japanese Adults (V116-002) (NCT NCT04665050)
NCT ID: NCT04665050
Last Updated: 2023-10-04
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included tenderness/pain, redness/erythema, and swelling. The percentage of participants with one or more solicited injection-site AE was reported for each arm.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
102 participants
Primary outcome timeframe
Up to 5 days postvaccination
Results posted on
2023-10-04
Participant Flow
Participant milestones
| Measure |
V116
Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.
|
PNEUMOVAX™23
Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
|
Overall Study
COMPLETED
|
51
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine (V116) in Japanese Adults (V116-002)
Baseline characteristics by cohort
| Measure |
V116
n=51 Participants
Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.
|
PNEUMOVAX™23
n=51 Participants
Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.1 Years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
64.0 Years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
63.6 Years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 days postvaccinationPopulation: All randomized participants who received study vaccination
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included tenderness/pain, redness/erythema, and swelling. The percentage of participants with one or more solicited injection-site AE was reported for each arm.
Outcome measures
| Measure |
V116
n=51 Participants
Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.
|
PNEUMOVAX™23
n=51 Participants
Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.
|
|---|---|---|
|
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Injection site pain
|
54.9 Percentage of Participants
|
66.7 Percentage of Participants
|
|
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Injection site erythema
|
9.8 Percentage of Participants
|
9.8 Percentage of Participants
|
|
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
Injection site swelling
|
13.7 Percentage of Participants
|
13.7 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 5 days postvaccinationPopulation: All randomized participants who received study vaccination
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs included headache, muscle pain/myalgia, joint pain/arthralgia, and tiredness/fatigue. The percentage of participants with one or more solicited systemic AE was reported for each arm.
Outcome measures
| Measure |
V116
n=51 Participants
Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.
|
PNEUMOVAX™23
n=51 Participants
Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.
|
|---|---|---|
|
Percentage of Participants With a Solicited Systemic AE
Fatigue
|
13.7 Percentage of participants
|
9.8 Percentage of participants
|
|
Percentage of Participants With a Solicited Systemic AE
Arthralgia
|
3.9 Percentage of participants
|
3.9 Percentage of participants
|
|
Percentage of Participants With a Solicited Systemic AE
Myalgia
|
17.6 Percentage of participants
|
19.6 Percentage of participants
|
|
Percentage of Participants With a Solicited Systemic AE
Headache
|
9.8 Percentage of participants
|
9.8 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to 62 days postvaccinationPopulation: All randomized participants who received study vaccination
An SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were reported.
Outcome measures
| Measure |
V116
n=51 Participants
Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.
|
PNEUMOVAX™23
n=51 Participants
Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.
|
|---|---|---|
|
Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 30 postvaccinationPopulation: All randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
The serotype-specific OPA GMTs for serotypes common to V116 and PNEUMOVAX™23 were determined using the multiplex opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group measures of dispersion (MOD) were not calculated.
Outcome measures
| Measure |
V116
n=51 Participants
Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.
|
PNEUMOVAX™23
n=51 Participants
Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.
|
|---|---|---|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23
Serotype 19A
|
1479.82 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
738.52 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23
Serotype 17F
|
8470.21 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
3293.31 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23
Serotype 20A
|
3542.90 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
1553.99 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23
Serotype 3
|
161.08 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
100.76 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23
Serotype 7F
|
5327.67 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
4406.11 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23
Serotype 22F
|
5768.79 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
3000.50 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23
Serotype 33F
|
33187.25 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
28831.77 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23
Serotype 8
|
1287.66 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
721.85 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23
Serotype 9N
|
6555.82 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
3466.72 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23
Serotype 10A
|
3608.34 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
1330.75 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23
Serotype 11A
|
1467.66 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
603.00 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23
Serotype 12F
|
1356.20 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
563.99 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
SECONDARY outcome
Timeframe: Day 30 postvaccinationPopulation: All randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
The GMCs for serotype-specific pneumococcal IgG antibodies were measured using pneumococcal electrochemiluminescence (PnECL). Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group MOD were not calculated.
Outcome measures
| Measure |
V116
n=51 Participants
Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.
|
PNEUMOVAX™23
n=51 Participants
Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.
|
|---|---|---|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23
Serotype 8
|
19.38 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
10.33 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23
Serotype 3
|
1.13 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
0.73 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23
Serotype 7F
|
10.29 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
4.66 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23
Serotype 19A
|
10.75 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
4.97 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23
Serotype 22F
|
3.94 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
1.69 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23
Serotype 33F
|
22.00 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
14.48 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23
Serotype 9N
|
14.17 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
5.99 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23
Serotype 10A
|
11.13 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
5.16 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23
Serotype 11A
|
9.07 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
4.71 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23
Serotype 12F
|
2.87 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
0.82 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23
Serotype 17F
|
19.46 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
6.77 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23
Serotype 20A
|
23.53 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
11.46 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
SECONDARY outcome
Timeframe: Day 30 postvaccinationPopulation: All randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
The serotype-specific OPA GMTs for serotypes unique to V116 were determined using the MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group MOD were not calculated.
Outcome measures
| Measure |
V116
n=51 Participants
Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.
|
PNEUMOVAX™23
n=51 Participants
Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.
|
|---|---|---|
|
Serotype-specific OPA GMTs for the Unique Serotypes in V116
Serotype 23B
|
2065.39 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
167.03 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific OPA GMTs for the Unique Serotypes in V116
Serotype 24F
|
2742.93 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
110.53 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific OPA GMTs for the Unique Serotypes in V116
Serotype 6A
|
1663.20 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
464.65 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific OPA GMTs for the Unique Serotypes in V116
Serotype 15A
|
5030.66 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
807.16 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific OPA GMTs for the Unique Serotypes in V116
Serotype 15C
|
3641.84 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
1565.56 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific OPA GMTs for the Unique Serotypes in V116
Serotype 16F
|
2459.26 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
244.49 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific OPA GMTs for the Unique Serotypes in V116
Serotype 23A
|
2620.19 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
62.26 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific OPA GMTs for the Unique Serotypes in V116
Serotype 31
|
1699.54 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
66.24 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific OPA GMTs for the Unique Serotypes in V116
Serotype 35B
|
4992.58 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
349.07 Titers
NA means that per protocol, no within-group MOD were planned or calculated.
|
SECONDARY outcome
Timeframe: Day 30 postvaccinationPopulation: All randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses
The GMCs for serotype-specific pneumococcal IgG antibodies unique to V116 were measured using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group MOD were not calculated.
Outcome measures
| Measure |
V116
n=51 Participants
Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.
|
PNEUMOVAX™23
n=51 Participants
Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.
|
|---|---|---|
|
Serotype-specific IgG GMCs for the Unique Serotypes in V116
Serotype 15C
|
21.42 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
6.81 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific IgG GMCs for the Unique Serotypes in V116
Serotype 16F
|
5.57 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
0.43 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific IgG GMCs for the Unique Serotypes in V116
Serotype 6A
|
6.38 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
2.13 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific IgG GMCs for the Unique Serotypes in V116
Serotype 15A
|
16.39 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
2.04 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific IgG GMCs for the Unique Serotypes in V116
Serotype 23B
|
8.56 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
2.06 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific IgG GMCs for the Unique Serotypes in V116
Serotype 24F
|
13.99 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
0.49 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific IgG GMCs for the Unique Serotypes in V116
Serotype 23A
|
4.14 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
0.48 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific IgG GMCs for the Unique Serotypes in V116
Serotype 31
|
5.25 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
0.51 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
|
Serotype-specific IgG GMCs for the Unique Serotypes in V116
Serotype 35B
|
24.61 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
1.54 μg/mL
NA means that per protocol, no within-group MOD were planned or calculated.
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 30 postvaccinationPopulation: All randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses for each serotype
GMTs for the serotypes in V116 and PNEUMOVAX™23 were determined using the MOPA at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR (Day 30 GMT/Day 1 GMT) from baseline (Day 1) to Day 30 of each pneumococcal serotype was calculated.
Outcome measures
| Measure |
V116
n=51 Participants
Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.
|
PNEUMOVAX™23
n=51 Participants
Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.
|
|---|---|---|
|
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
Serotype 17F
|
23.63 Ratio
Interval 13.4 to 41.68
|
11.40 Ratio
Interval 7.07 to 18.4
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
Serotype 20A
|
11.69 Ratio
Interval 7.27 to 18.81
|
5.94 Ratio
Interval 4.12 to 8.57
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
Serotype 3
|
9.86 Ratio
Interval 7.07 to 13.75
|
6.35 Ratio
Interval 4.43 to 9.1
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
Serotype 7F
|
19.79 Ratio
Interval 10.6 to 36.94
|
21.53 Ratio
Interval 11.79 to 39.3
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
Serotype 6C
|
5.63 Ratio
Interval 3.17 to 9.99
|
4.00 Ratio
Interval 2.21 to 7.24
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
Serotype 15B
|
35.68 Ratio
Interval 18.43 to 69.08
|
23.54 Ratio
Interval 13.35 to 41.5
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
Serotype 20B
|
6.08 Ratio
Interval 3.16 to 11.71
|
8.89 Ratio
Interval 5.29 to 14.95
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
Serotype 19A
|
10.80 Ratio
Interval 7.27 to 16.04
|
6.74 Ratio
Interval 4.45 to 10.18
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
Serotype 22F
|
15.14 Ratio
Interval 8.25 to 27.79
|
18.13 Ratio
Interval 9.17 to 35.85
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
Serotype 33F
|
11.47 Ratio
Interval 8.2 to 16.04
|
11.62 Ratio
Interval 7.91 to 17.06
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
Serotype 8
|
102.33 Ratio
Interval 75.07 to 139.5
|
48.14 Ratio
Interval 32.69 to 70.88
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
Serotype 9N
|
55.49 Ratio
Interval 31.26 to 98.5
|
40.11 Ratio
Interval 22.97 to 70.03
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
Serotype 10A
|
31.29 Ratio
Interval 15.34 to 63.81
|
21.93 Ratio
Interval 12.29 to 39.11
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
Serotype 11A
|
42.06 Ratio
Interval 25.15 to 70.32
|
20.68 Ratio
Interval 12.11 to 35.33
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
Serotype 12F
|
94.74 Ratio
Interval 54.15 to 165.76
|
44.70 Ratio
Interval 24.59 to 81.24
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
Serotype 6A
|
22.76 Ratio
Interval 12.66 to 40.93
|
8.31 Ratio
Interval 5.24 to 13.17
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
Serotype 15A
|
10.70 Ratio
Interval 6.31 to 18.13
|
3.02 Ratio
Interval 1.67 to 5.43
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
Serotype 15C
|
36.53 Ratio
Interval 18.49 to 72.15
|
16.72 Ratio
Interval 9.39 to 29.76
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
Serotype 16F
|
14.74 Ratio
Interval 8.27 to 26.28
|
1.84 Ratio
Interval 1.1 to 3.06
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
Serotype 23A
|
46.69 Ratio
Interval 25.58 to 85.22
|
1.93 Ratio
Interval 1.05 to 3.56
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
Serotype 23B
|
43.21 Ratio
Interval 25.15 to 74.23
|
4.43 Ratio
Interval 3.0 to 6.54
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
Serotype 24F
|
9.21 Ratio
Interval 5.06 to 16.78
|
0.75 Ratio
Interval 0.4 to 1.4
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
Serotype 31
|
27.99 Ratio
Interval 16.04 to 48.85
|
1.22 Ratio
Interval 0.75 to 2.01
|
|
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
Serotype 35B
|
7.39 Ratio
Interval 4.32 to 12.67
|
0.56 Ratio
Interval 0.41 to 0.78
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Day 30 postvaccinationPopulation: All randomized participants without deviations from the protocol that may have substantially affected the results of this immunogenicity endpoint and who had sufficient data to perform the analyses for each serotype
GMCs for the serotypes in V116 and PNEUMOVAX™23 were measured by PnECL at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR (Day 30 GMC/Day 1 GMC) from baseline (Day 1) to Day 30 of each pneumococcal serotype was calculated.
Outcome measures
| Measure |
V116
n=51 Participants
Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.
|
PNEUMOVAX™23
n=51 Participants
Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.
|
|---|---|---|
|
GMFR From Baseline in Serotype-specific IgG GMCs
Serotype 23B
|
14.04 Ratio
Interval 9.14 to 21.58
|
3.22 Ratio
Interval 2.55 to 4.06
|
|
GMFR From Baseline in Serotype-specific IgG GMCs
Serotype 31
|
17.97 Ratio
Interval 12.37 to 26.1
|
1.64 Ratio
Interval 1.28 to 2.09
|
|
GMFR From Baseline in Serotype-specific IgG GMCs
Serotype 35B
|
16.93 Ratio
Interval 11.99 to 23.9
|
1.10 Ratio
Interval 1.05 to 1.15
|
|
GMFR From Baseline in Serotype-specific IgG GMCs
Serotype 3
|
5.92 Ratio
Interval 4.25 to 8.24
|
4.47 Ratio
Interval 3.48 to 5.74
|
|
GMFR From Baseline in Serotype-specific IgG GMCs
Serotype 7F
|
23.86 Ratio
Interval 16.2 to 35.14
|
10.51 Ratio
Interval 7.57 to 14.58
|
|
GMFR From Baseline in Serotype-specific IgG GMCs
Serotype 19A
|
7.58 Ratio
Interval 5.51 to 10.44
|
3.52 Ratio
Interval 2.71 to 4.56
|
|
GMFR From Baseline in Serotype-specific IgG GMCs
Serotype 22F
|
14.68 Ratio
Interval 9.24 to 23.3
|
6.57 Ratio
Interval 4.65 to 9.28
|
|
GMFR From Baseline in Serotype-specific IgG GMCs
Serotype 33F
|
21.61 Ratio
Interval 14.49 to 32.23
|
11.52 Ratio
Interval 8.24 to 16.13
|
|
GMFR From Baseline in Serotype-specific IgG GMCs
Serotype 8
|
31.58 Ratio
Interval 22.46 to 44.39
|
16.71 Ratio
Interval 12.61 to 22.14
|
|
GMFR From Baseline in Serotype-specific IgG GMCs
Serotype 9N
|
24.26 Ratio
Interval 16.6 to 35.46
|
10.56 Ratio
Interval 8.01 to 13.92
|
|
GMFR From Baseline in Serotype-specific IgG GMCs
Serotype 10A
|
15.70 Ratio
Interval 10.45 to 23.59
|
7.19 Ratio
Interval 5.13 to 10.07
|
|
GMFR From Baseline in Serotype-specific IgG GMCs
Serotype 11A
|
9.31 Ratio
Interval 6.51 to 13.31
|
4.64 Ratio
Interval 3.47 to 6.22
|
|
GMFR From Baseline in Serotype-specific IgG GMCs
Serotype 12F
|
23.87 Ratio
Interval 15.22 to 37.44
|
6.53 Ratio
Interval 4.52 to 9.44
|
|
GMFR From Baseline in Serotype-specific IgG GMCs
Serotype 17F
|
20.71 Ratio
Interval 15.14 to 28.33
|
7.37 Ratio
Interval 5.6 to 9.69
|
|
GMFR From Baseline in Serotype-specific IgG GMCs
Serotype 20A
|
11.68 Ratio
Interval 8.14 to 16.77
|
6.19 Ratio
Interval 4.57 to 8.38
|
|
GMFR From Baseline in Serotype-specific IgG GMCs
Serotype 6A
|
14.01 Ratio
Interval 8.99 to 21.86
|
4.67 Ratio
Interval 3.28 to 6.63
|
|
GMFR From Baseline in Serotype-specific IgG GMCs
Serotype 15A
|
32.11 Ratio
Interval 18.79 to 54.89
|
3.34 Ratio
Interval 2.52 to 4.44
|
|
GMFR From Baseline in Serotype-specific IgG GMCs
Serotype 15C
|
42.20 Ratio
Interval 25.71 to 69.25
|
11.50 Ratio
Interval 7.83 to 16.88
|
|
GMFR From Baseline in Serotype-specific IgG GMCs
Serotype 16F
|
21.00 Ratio
Interval 14.13 to 31.23
|
1.52 Ratio
Interval 1.33 to 1.73
|
|
GMFR From Baseline in Serotype-specific IgG GMCs
Serotype 23A
|
18.42 Ratio
Interval 12.28 to 27.63
|
2.26 Ratio
Interval 1.67 to 3.06
|
|
GMFR From Baseline in Serotype-specific IgG GMCs
Serotype 24F
|
31.58 Ratio
Interval 18.26 to 54.6
|
1.15 Ratio
Interval 1.01 to 1.31
|
|
GMFR From Baseline in Serotype-specific IgG GMCs
Serotype 6C
|
5.94 Ratio
Interval 4.25 to 8.3
|
2.21 Ratio
Interval 1.79 to 2.74
|
|
GMFR From Baseline in Serotype-specific IgG GMCs
Serotype 15B
|
11.14 Ratio
Interval 7.39 to 16.78
|
8.61 Ratio
Interval 6.14 to 12.08
|
Adverse Events
V116
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
PNEUMOVAX™23
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
V116
n=51 participants at risk
Participants received a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.
|
PNEUMOVAX™23
n=51 participants at risk
Participants received a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.
|
|---|---|---|
|
General disorders
Fatigue
|
13.7%
7/51 • Number of events 7 • Up to 62 days postvaccination.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
9.8%
5/51 • Number of events 5 • Up to 62 days postvaccination.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
|
General disorders
Injection site erythema
|
9.8%
5/51 • Number of events 5 • Up to 62 days postvaccination.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
9.8%
5/51 • Number of events 5 • Up to 62 days postvaccination.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
|
General disorders
Injection site pain
|
54.9%
28/51 • Number of events 28 • Up to 62 days postvaccination.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
66.7%
34/51 • Number of events 34 • Up to 62 days postvaccination.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
|
General disorders
Injection site swelling
|
13.7%
7/51 • Number of events 7 • Up to 62 days postvaccination.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
13.7%
7/51 • Number of events 7 • Up to 62 days postvaccination.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
|
General disorders
Pyrexia
|
0.00%
0/51 • Up to 62 days postvaccination.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
5.9%
3/51 • Number of events 3 • Up to 62 days postvaccination.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.6%
9/51 • Number of events 9 • Up to 62 days postvaccination.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
19.6%
10/51 • Number of events 10 • Up to 62 days postvaccination.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
|
Nervous system disorders
Headache
|
9.8%
5/51 • Number of events 6 • Up to 62 days postvaccination.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
9.8%
5/51 • Number of events 5 • Up to 62 days postvaccination.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER