JPRN-jRCT2080222978
Completed
Phase 1
An open-label, randomized, clinical study assessing the safety and immunogenicity of JVC-001 in Japanese healthy children
ConditionsPrevention of measles, mumps and rubella
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Prevention of measles, mumps and rubella
- Sponsor
- DAIICHI SANKYO Co.,Ltd.
- Enrollment
- 100
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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