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A Blind, Randomized and Controlled Clinical Trial With Live Attenuated Mumps Vaccines in Healthy Infants
The purpose of this study is to evaluate the immunogenicity and safety of a live attenuated mumps vaccine in healthy infants between 8 - 18 months old with a commercialized live attenuated mumps vaccine as the control vaccine.
Details
| Lead sponsor | Sinovac Research and Development Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 1140 |
| Start date | 2016-01 |
| Completion | 2016-04 |
Conditions
- Mumps
Interventions
- Investigational live attenuated mumps vaccine
- control live attenuated mumps vaccine
Primary outcomes
- The seroconversion rates (SCRs) of susceptible subjects in each group — 28 days
Subjects whose pre-immune HI antibody level \< 1:2 are considered susceptible; among these subjects, those with post-immune HI antibody level ≥ 1:2 are considered seroconverted.
Countries
China