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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Pneumococcal Infection

Treatments

Biological: PNEUMOVAX™23

Biological: V116

Study type

Interventional

Funder types

Industry

Identifiers

NCT04665050

jRCT2071200094 (Registry Identifier)

pPCV-002 (Other Identifier)

V116-002 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

102 patients

Sex

All

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

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