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

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.

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.

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