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

Phase 1

Completed

Conditions: Pneumococcal Infection

Interventions: Biological: PNEUMOVAX™23
Biological: V116

Registration Number: NCT04665050

Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 102

Inclusion Criteria

is a healthy Japanese male or female ≥20 years of age at time of randomization
male participants must agree to be abstinent or use contraception during the intervention period and for ≥30 days after the last dose of study intervention
female participants must not be pregnant or breastfeeding, and is either:
not a woman of childbearing potential (WOCBP) or
a WOCBP who agrees to remain abstinent or use contraception during the intervention period and for ≥30 days after the last dose of study intervention

Exclusion Criteria

has a history of invasive pneumococcal disease (IPD) within 3 years of Day 1
has a known hypersensitivity to any vaccine components
has impaired immunological function
has a coagulation disorder
had a recent febrile illness (axillary temperature ≥37.5°C or equivalent) within 72 hours before Day 1
has a known malignancy that is progressing/requiring treatment
has received, or is expected to receive, a pneumococcal vaccine outside the study protocol
has received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed the regimen for ≥30 days prior to Day 1
is receiving immunosuppressive therapy
has received any non-live vaccine from 14 days prior to Day 1 other than inactivated influenza vaccine
has received any live vaccine from 30 days prior to Day 1
has received a blood transfusion or blood products
has participated in another clinical trial within 2 months of this study
has clinically relevant drug or alcohol abuse
has any condition that, in the opinion of the investigator, precludes participation in this study

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PNEUMOVAX™23	PNEUMOVAX™23	Participants receive a single 0.5 mL IM injection of PNEUMOVAX™23 on Day 1.
V116	V116	Participants receive a single 1.0 mL intramuscular (IM) injection of V116 on Day 1.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With a Solicited Systemic AE	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.
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)	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.
Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)	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.

Secondary Outcome Measures

Name	Time	Method
Serotype-specific OPA GMTs for the Unique Serotypes in V116	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.
Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA	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-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23	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.
GMFR From Baseline in Serotype-specific IgG GMCs	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-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23	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-specific IgG GMCs for the Unique Serotypes in V116	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.