Phase 1 Study of a pPCV in Healthy Japanese Adults

Phase 1

• Conditions: Pneumococcal infection prevention

• Registration Number: JPRN-jRCT2071200094
• Lead Sponsor: Tanaka Yoshiyuki

Brief Summary

The following key results were observed in pneumococcal vaccine-naive adults >=20 years of age: - Serotype-specific OPA GMTs and IgG GMCs following vaccination were generally higher in the V116 group than the PPSV23 group for the common serotypes. - Serotype-specific OPA GMTs and IgG GMCs following vaccination were higher in the V116 group than the PPSV23 group for the unique serotypes. - V116 was well tolerated with a safety profile that was generally comparable to that of PPSV23.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-29
• Study Completion: 2021-04-06
• Results First Posted: 2023-06-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 102

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 study and for >=30 days after completing the study
- 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 study and for >=30 days after completing the study

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 >=37.5C 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified