Safety and Immunogenicity of V116 in Vaccine-Experienced Adults
Phase 3
- Conditions
- Pneumococcal infection prevention
- Registration Number
- JPRN-jRCT2071220025
- Lead Sponsor
- Tanaka Yoshiyuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 63
Inclusion Criteria
The participant may have underlying chronic conditions if they are assessed to be stable as per the investigator's judgment.
- Is male or female, =>50 years of age, at the time of informed consent.
- Is pneumococcal vaccine-experienced, defined as prior receipt (=>1 year before enrollment)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Solicited AEs and Vaccine-related SAEs<br>- Serotype-specific OPA responses
- Secondary Outcome Measures
Name Time Method Serotype-specific OPA and IgG responses