Open study of quadrivalent VN-100 in Japanese healthy volunteers
Phase 3
Completed
- Conditions
- Prophylaxis of influenza infection
- Registration Number
- JPRN-jRCT2080222562
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd.
- Brief Summary
As a result of 2nd intradermal vaccinated of quadrivalent VN-100 in healthy Japanese 13 years and older, no serious AEs or AEs leading to this study discontinuation occurred. Therefore we thought there was no serious issues with safety. In addition, HI antibody titer, SRH antibody titer, and neutralizing antibody titer increased after vaccinated of quadrivalent VN-100, confirming good immunogenicity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Japanese healthy volunteers
Exclusion Criteria
1) Subjects with history of seasonal influenza in the past 6 months
2) Subjects with history of seasonal influenza vaccination in the past 6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>1) Safety endpoints: adverse events, laboratory values and body temperature<br>2) Immunology endpoints: HI antibody titer, SRH antibody titer and neutralizing antibody titer
- Secondary Outcome Measures
Name Time Method