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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05065177
Other study ID # PRO-MUMPS-3001
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 2016
Est. completion date April 2016

Study information

Verified date July 2021
Source Sinovac Biotech Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

This study is a randomized, blind, single-center, controlled phase III clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of a live attenuated mumps vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The control vaccine is a commercialized live attenuated mumps vaccine manufactured by ZheJiang VACN bio-pharmaceutical Co. Ltd. All participants are healthy infants between 8 - 18 months old, and will be randomly assigned into experimental group or control group in the ratio 1:1.


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Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Investigational live attenuated mumps vaccine
The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
control live attenuated mumps vaccine
The control vaccine was manufactured by Zhejiang VACN bio-pharmaceutical Co. Ltd.

Locations

Country Name City State
China Dingxing County Center for Disease Control and Prevention Dingxing Hebei

Sponsors (1)

Lead Sponsor Collaborator
Sinovac Research and Development Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The seroconversion rates (SCRs) of susceptible subjects in each group 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. 28 days
Secondary The incidences of adverse events (AEs) of each group AEs occurred within 28 days after injection will be collected. 28 days
Secondary The incidences of serious adverse events (SAEs) of each group SAEs occurred within 28 days after injection will be collected. 28 days
Secondary The post-immune geometric mean titers (GMTs) of susceptible subjects in each group Subjects whose pre-immune HI antibody level < 1:2 are considered susceptible. 28 days
Secondary The overall SCRs of each group Subjects whose pre-immune HI antibody level < 1:2 and post-immune antibody level = 1:2, or those whose pre-immune antibody level = 1:2 and the increase of post-immune HI antibody level = 4 folds are considered seroconverted. 28 days
Secondary The overall post-immune GMTs of each group The GMTs of all the subjects in each group. 28 days
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