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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,140
The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
The control vaccine was manufactured by Zhejiang VACN bio-pharmaceutical Co. Ltd.
Dingxing County Center for Disease Control and Prevention
Dingxing, Hebei, China
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.
Time frame: 28 days
The incidences of adverse events (AEs) of each group
AEs occurred within 28 days after injection will be collected.
Time frame: 28 days
The incidences of serious adverse events (SAEs) of each group
SAEs occurred within 28 days after injection will be collected.
Time frame: 28 days
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.
Time frame: 28 days
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.
Time frame: 28 days
The overall post-immune GMTs of each group
The GMTs of all the subjects in each group.
Time frame: 28 days
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