Phase I/II clinical study of JVC-001
Phase 1
Completed
- Conditions
- Prevention of measles, mumps and rubella
- Registration Number
- JPRN-jRCT2080222978
- Lead Sponsor
- DAIICHI SANKYO Co.,Ltd.
- Brief Summary
JVC-001 or control vaccines were injected once each subcutaneously in Japanese healthy children. Day 42, antibody titers against measles, rubella and mumps viruses antigens were measured. Seroconversion rate of antibodies against measles virus and rubella virus were 100% in both groups, and seroresponse rate and GMT for anti-mumps virus antibody by the unenhanced PRNT method were at sufficient levels in both groups. The incident of most AEs were comparable in both groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Aged 12 months and older and younger than 24 months
Exclusion Criteria
1) Subjects with history of measles, mumps, or rubella infection
2) 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 safety<br>efficacy<br>1) immunogenicity against measles virus, rubella virus and mumps virus (Genotype D)<br>2) Adverse events, solicited adverse events/symptoms (local, general)
- Secondary Outcome Measures
Name Time Method efficacy<br>immunogenicity against several genotypes of mumps viruses