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Clinical Trials/JPRN-jRCT2080222978
JPRN-jRCT2080222978
Completed
Phase 1

An open-label, randomized, clinical study assessing the safety and immunogenicity of JVC-001 in Japanese healthy children

DAIICHI SANKYO Co.,Ltd.0 sites100 target enrollmentOctober 5, 2015

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.

Registry
who.int
Start Date
October 5, 2015
End Date
March 23, 2016
Last Updated
2 years ago
Study Type
Interventional
Sex
All

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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