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NCT04665050

Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine (V116) in Japanese Adults (V116-002)

Completed Phase 1 Results posted Last updated 4 October 2023
What this trial tests

Phase 1 trial testing V116 in Pneumococcal Infection in 102 participants. Completed in 6 April 2021.

Timeline
4 February 2021
Primary endpoint
6 April 2021
6 April 2021

Quick facts

Lead sponsorMerck Sharp & Dohme LLC
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment102
Start date4 February 2021
Primary completion6 April 2021
Estimated completion6 April 2021
Sites2 locations across Japan

Drugs / interventions tested

Conditions studied

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

20 and older, any sex, with Pneumococcal Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With a Solicited Injection-site Adverse Event (AE) Primary · Up to 5 days postvaccination

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.

Injection site erythema
GroupValue95% CI
V1169.8
PNEUMOVAX™239.8
Injection site pain
GroupValue95% CI
V11654.9
PNEUMOVAX™2366.7
Injection site swelling
GroupValue95% CI
V11613.7
PNEUMOVAX™2313.7
Percentage of Participants With a Solicited Systemic AE Primary · Up to 5 days postvaccination

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.

Fatigue
GroupValue95% CI
V11613.7
PNEUMOVAX™239.8
Arthralgia
GroupValue95% CI
V1163.9
PNEUMOVAX™233.9
Myalgia
GroupValue95% CI
V11617.6
PNEUMOVAX™2319.6
Headache
GroupValue95% CI
V1169.8
PNEUMOVAX™239.8
Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) Primary · Up to 62 days postvaccination

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.

GroupValue95% CI
V1160.0
PNEUMOVAX™230.0
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23 Secondary · Day 30 postvaccination

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.

Serotype 3
GroupValue95% CI
V116161.08NA – NA
PNEUMOVAX™23100.76NA – NA
Serotype 7F
GroupValue95% CI
V1165327.67NA – NA
PNEUMOVAX™234406.11NA – NA
Serotype 19A
GroupValue95% CI
V1161479.82NA – NA
PNEUMOVAX™23738.52NA – NA
Serotype 22F
GroupValue95% CI
V1165768.79NA – NA
PNEUMOVAX™233000.50NA – NA
Serotype 33F
GroupValue95% CI
V11633187.25NA – NA
PNEUMOVAX™2328831.77NA – NA
Serotype 8
GroupValue95% CI
V1161287.66NA – NA
PNEUMOVAX™23721.85NA – NA
Serotype 9N
GroupValue95% CI
V1166555.82NA – NA
PNEUMOVAX™233466.72NA – NA
Serotype 10A
GroupValue95% CI
V1163608.34NA – NA
PNEUMOVAX™231330.75NA – NA
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23 Secondary · Day 30 postvaccination

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.

Serotype 3
GroupValue95% CI
V1161.13NA – NA
PNEUMOVAX™230.73NA – NA
Serotype 7F
GroupValue95% CI
V11610.29NA – NA
PNEUMOVAX™234.66NA – NA
Serotype 19A
GroupValue95% CI
V11610.75NA – NA
PNEUMOVAX™234.97NA – NA
Serotype 22F
GroupValue95% CI
V1163.94NA – NA
PNEUMOVAX™231.69NA – NA
Serotype 33F
GroupValue95% CI
V11622.00NA – NA
PNEUMOVAX™2314.48NA – NA
Serotype 8
GroupValue95% CI
V11619.38NA – NA
PNEUMOVAX™2310.33NA – NA
Serotype 9N
GroupValue95% CI
V11614.17NA – NA
PNEUMOVAX™235.99NA – NA
Serotype 10A
GroupValue95% CI
V11611.13NA – NA
PNEUMOVAX™235.16NA – NA
Serotype-specific OPA GMTs for the Unique Serotypes in V116 Secondary · Day 30 postvaccination

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.

Serotype 6A
GroupValue95% CI
V1161663.20NA – NA
PNEUMOVAX™23464.65NA – NA
Serotype 15A
GroupValue95% CI
V1165030.66NA – NA
PNEUMOVAX™23807.16NA – NA
Serotype 15C
GroupValue95% CI
V1163641.84NA – NA
PNEUMOVAX™231565.56NA – NA
Serotype 16F
GroupValue95% CI
V1162459.26NA – NA
PNEUMOVAX™23244.49NA – NA
Serotype 23A
GroupValue95% CI
V1162620.19NA – NA
PNEUMOVAX™2362.26NA – NA
Serotype 23B
GroupValue95% CI
V1162065.39NA – NA
PNEUMOVAX™23167.03NA – NA
Serotype 24F
GroupValue95% CI
V1162742.93NA – NA
PNEUMOVAX™23110.53NA – NA
Serotype 31
GroupValue95% CI
V1161699.54NA – NA
PNEUMOVAX™2366.24NA – NA
Serotype-specific IgG GMCs for the Unique Serotypes in V116 Secondary · Day 30 postvaccination

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.

Serotype 6A
GroupValue95% CI
V1166.38NA – NA
PNEUMOVAX™232.13NA – NA
Serotype 15A
GroupValue95% CI
V11616.39NA – NA
PNEUMOVAX™232.04NA – NA
Serotype 15C
GroupValue95% CI
V11621.42NA – NA
PNEUMOVAX™236.81NA – NA
Serotype 16F
GroupValue95% CI
V1165.57NA – NA
PNEUMOVAX™230.43NA – NA
Serotype 23A
GroupValue95% CI
V1164.14NA – NA
PNEUMOVAX™230.48NA – NA
Serotype 23B
GroupValue95% CI
V1168.56NA – NA
PNEUMOVAX™232.06NA – NA
Serotype 24F
GroupValue95% CI
V11613.99NA – NA
PNEUMOVAX™230.49NA – NA
Serotype 31
GroupValue95% CI
V1165.25NA – NA
PNEUMOVAX™230.51NA – NA
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA Secondary · Baseline (Day 1) and Day 30 postvaccination

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.

Serotype 3
GroupValue95% CI
V1169.867.07 – 13.75
PNEUMOVAX™236.354.43 – 9.10
Serotype 7F
GroupValue95% CI
V11619.7910.60 – 36.94
PNEUMOVAX™2321.5311.79 – 39.30
Serotype 19A
GroupValue95% CI
V11610.807.27 – 16.04
PNEUMOVAX™236.744.45 – 10.18
Serotype 22F
GroupValue95% CI
V11615.148.25 – 27.79
PNEUMOVAX™2318.139.17 – 35.85
Serotype 33F
GroupValue95% CI
V11611.478.20 – 16.04
PNEUMOVAX™2311.627.91 – 17.06
Serotype 8
GroupValue95% CI
V116102.3375.07 – 139.50
PNEUMOVAX™2348.1432.69 – 70.88
Serotype 9N
GroupValue95% CI
V11655.4931.26 – 98.50
PNEUMOVAX™2340.1122.97 – 70.03
Serotype 10A
GroupValue95% CI
V11631.2915.34 – 63.81
PNEUMOVAX™2321.9312.29 – 39.11
GMFR From Baseline in Serotype-specific IgG GMCs Secondary · Baseline (Day 1) and Day 30 postvaccination

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.

Serotype 3
GroupValue95% CI
V1165.924.25 – 8.24
PNEUMOVAX™234.473.48 – 5.74
Serotype 7F
GroupValue95% CI
V11623.8616.20 – 35.14
PNEUMOVAX™2310.517.57 – 14.58
Serotype 19A
GroupValue95% CI
V1167.585.51 – 10.44
PNEUMOVAX™233.522.71 – 4.56
Serotype 22F
GroupValue95% CI
V11614.689.24 – 23.30
PNEUMOVAX™236.574.65 – 9.28
Serotype 33F
GroupValue95% CI
V11621.6114.49 – 32.23
PNEUMOVAX™2311.528.24 – 16.13
Serotype 8
GroupValue95% CI
V11631.5822.46 – 44.39
PNEUMOVAX™2316.7112.61 – 22.14
Serotype 9N
GroupValue95% CI
V11624.2616.60 – 35.46
PNEUMOVAX™2310.568.01 – 13.92
Serotype 10A
GroupValue95% CI
V11615.7010.45 – 23.59
PNEUMOVAX™237.195.13 – 10.07

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 62 days postvaccination.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

V116
Serious: 0/51 (0%)
Deaths: 0/51
PNEUMOVAX™23
Serious: 0/51 (0%)
Deaths: 0/51
Other adverse events (7 terms — click to expand)

ReactionSystemV116PNEUMOVAX™23
Injection site painGeneral disorders——
MyalgiaMusculoskeletal and connective tissue disorders——
FatigueGeneral disorders——
Injection site swellingGeneral disorders——
Injection site erythemaGeneral disorders——
HeadacheNervous system disorders——
PyrexiaGeneral disorders——

Data from ClinicalTrials.gov NCT04665050 adverse events section.

Sponsor's own description

The purpose of this study is to compare the safety, tolerability, and immunogenicity of a polyvalent pneumococcal conjugate vaccine (V116) with that of PNEUMOVAX™23 in healthy Japanese adults.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Safety, tolerability, and immunogenicity of a 21-valent pneumococcal conjugate vaccine, V116, in Japanese healthy adults: A Phase I study.
    Haranaka M, Yono M, Kishino H, Igarashi R, et al · · 2023 · cited 11× · PMID 37389808 · DOI 10.1080/21645515.2023.2228162
  2. Il vaccino coniugato antipneumococcico 21-valente per la prevenzione delle infezioni da <i>Streptococcus pneumoniae</i> in età adulta: una valutazione di <i>Health Technology Assessment</i>.
    Calabrò GE, Rizzo C, Baldo V, Cocchio S, et al · · 2026 · PMID 42006177 · DOI 10.15167/2421-4248/jpmh2025.66.3s1

Verify or expand the search:

Other trials of V116

Trials testing the same drug.

Other recruiting trials for Pneumococcal Infection

Currently open trials in the same condition.

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Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing