Status:
COMPLETED
Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine (V116) in Japanese Adults (V116-002)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Pneumococcal Infection
Eligibility:
All Genders
20+ years
Phase:
PHASE1
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
- 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
- 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
Key Trial Info
Start Date :
February 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2021
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04665050
Start Date
February 4 2021
End Date
April 6 2021
Last Update
October 4 2023
Active Locations (2)
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1
Souseikai PS Clinic ( Site 0201)
Fukuoka, Japan, 812-0025
2
Souseikai Nishikumamoto Hospital ( Site 0202)
Kumamoto, Japan, 861-4157