VN-100 Ph3 non-inferiority study
Phase 3
Completed
- Conditions
- Prophylaxis of influenza infection
- Registration Number
- JPRN-jRCT2080222443
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd.
- Brief Summary
As a result of 1st intradermal vaccinated of VN-100 in healthy Japanese 65 years and older, seroconversion rate and GMT of HI antibody titer were confirmed to be good immunogenicity in any strain, and influenza HA vaccine non-inferiority for a 1st subcutaneous inoculation was verified. There were no serious safety problems in the safety of VN-100 group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 901
Inclusion Criteria
Healthy elderly Japanese 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
- Secondary Outcome Measures
Name Time Method