Safety and Immunogenicity of V116 in Vaccine-Experienced Adults

JRCT ID: jRCT2071220025

Registered date:08/07/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Pneumococcal infection prevention
• Date of first enrollment: 02/08/2022
• Target sample size: 63
• Countries of recruitment: USA,Japan,Canada,Japan,France,Japan,Israel,Japan,Italy,Japan,South Korea,Japan,Spain,Japan,Taiwan,Japan
• Study type: Interventional
• Intervention(s): V116 (0.5 mL) ,PCV15(0.5 mL) or PPSV23 (0.5 mL) will be administered as a single IM injection.

Outcome(s)

Primary Outcome

- Solicited AEs and Vaccine-related SAEs
- Serotype-specific OPA responses

• Secondary Outcome: Serotype-specific OPA and IgG responses

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Both

Include 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)

Exclude 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

Related Information

• Primary Sponsor: Tanaka Yoshiyuki
• Secondary ID(s): NCT05420961