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

Merck Sharp & Dohme LLC102 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

102

Conditions

Pneumococcal Infection

Interventions

V116BIOLOGICAL

Pneumococcal 21-valent conjugate vaccine with 2 μg of each of the following 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

PNEUMOVAX™23BIOLOGICAL

Pneumococcal 23-valent polyvalent vaccine with 25 μg of each of the following 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

Eligibility

Sex: ALLMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Souseikai PS Clinic ( Site 0201)

Fukuoka, Japan

Souseikai Nishikumamoto Hospital ( Site 0202)

Kumamoto, Japan

Outcomes

Primary Outcomes

Percentage of Participants With a Solicited Injection-site Adverse Event (AE)

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.

Time frame: Up to 5 days postvaccination

Percentage of Participants With a Solicited Systemic AE

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.

Time frame: Up to 5 days postvaccination

Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)

An SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were reported.

Time frame: Up to 62 days postvaccination

Secondary Outcomes

Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23

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.

Data from ClinicalTrials.gov

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