The purpose of this study is to evaluate the safety and immunogenicity of mumps vaccine in healthy infants aged 8-12months, compared with measles, mumps and rubella combined vaccine, live (MMRV).
The study is a randomized, double-blind, controlled phase Ⅳ clinical trial. And 920 infants will be assigned to investigational group and controlled group in a 1:1 ratio. The investigational vaccine is manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The controlled vaccine is manufactured by Shanghai institute of biological products Co., Ltd.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
920
One dose of mumps vaccine: 0.5 ml per dose, mumps live virus not less than 3.7 lg CCID50
One dose of measles, mumps and rubella combined vaccine, live: 0.5 ml per dose, mumps live virus not less than 4.3 lg CCID50
Hezhou Center for Disease Prevention and Control
Hezhou, Guangxi, China
The seroconversion rate of hemagglutination inhibition (HI) antibody
Immunogenicity index, One of the standard to evaluate the immunogenicity of experimental vaccine
Time frame: the 30th day after vaccination
The GMT of HI antibody
Immunogenicity index, Another standard to evaluate the immunogenicity of experimental vaccine
Time frame: the 30th day after vaccination
The incidence of the solicited local and systemic adverse reactions
Safety index, The adverse reactions refers to the adverse events which were considered related to the vaccination
Time frame: from day 0 to day 14 after vaccination
The incidence of the unsolicited adverse events
Safety Index
Time frame: from day 0 to day 30 after immunization
The incidence of the serious adverse events
Safety Index
Time frame: from day 0 to day 30 after immunization
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