A Phase 3, Randomized, Observer-blinded Study of Low and High titer JVC-001 in Healthy Japanese Children 1 Year of Age
Phase 3
Completed
- Conditions
- Prophylaxis of measles, mumps, and rubella
- Registration Number
- JPRN-jRCT2080225025
- Lead Sponsor
- DAIICHI SANKYO Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Japanese healthy children of 12 months and older and younger than 24 months
Exclusion Criteria
- Subjects with history of measles, mumps, or rubella infection
- Subjects with measles, mumps, or rubella infection
- Subjects with history of measles, mumps, or rubella virus vaccination
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>- Seroprotection rate of anti-measles virus antibody<br>- Seroprotection rate of anti-rubella virus antibody<br>- Seroprotection rate of anti-mumps virus antibody
- Secondary Outcome Measures
Name Time Method efficacy<br>- Seroconversion rate and GMT of anti-measles virus antibody<br>- Seroconversion rate and GMT of anti-rubella virus antibody<br>- Seroconversion rate, seroresponse rate, and GMT of anti-mumps virus antibody