Clinical trial NCT04665050: Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine (V116) in Japanese Adults (V116-002)
Official title: A Phase 1, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine in Healthy Japanese Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pneumococcal Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2020-12-11
Enrollment: 102
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
timeFrame: Up to 5 days postvaccination
measure: Percentage of Participants With a Solicited Systemic AE
timeFrame: Up to 5 days postvaccination
measure: Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)
timeFrame: Up to 62 days postvaccination
Secondary outcomes:
measure: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and PNEUMOVAX™23
timeFrame: Day 30 postvaccination
measure: Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and PNEUMOVAX™23
timeFrame: Day 30 postvaccination
measure: Serotype-specific OPA GMTs for the Unique Serotypes in V116
timeFrame: Day 30 postvaccination
measure: Serotype-specific IgG GMCs for the Unique Serotypes in V116
timeFrame: Day 30 postvaccination
measure: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA
timeFrame: Baseline (Day 1) and Day 30 postvaccination
measure: GMFR From Baseline in Serotype-specific IgG GMCs
timeFrame: Baseline (Day 1) and Day 30 postvaccination
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Souseikai PS Clinic ( Site 0201)
city: Kumamoto
country: Japan
facility: Souseikai Nishikumamoto Hospital ( Site 0202)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Haranaka M, Yono M, Kishino H, Igarashi R, Oshima N, Sawata M, Platt HL. Safety, tolerability, and immunogenicity of a 21-valent pneumococcal conjugate vaccine, V116, in Japanese healthy adults: A Phase I study. Hum Vaccin Immunother. 2023 Aug 1;19(2):2228162. doi: 10.1080/21645515.2023.2228162.