The purpose of this study is to evaluate the safety and immunogenicity of concomitant administration of EV71 vaccine with measles mumps, and rubella combined live attenuated vaccine/ encephalitis live attenuated vaccine.
This study is an open-label, single-center, randomized, comparative phase IV clinical trial. The purpose of this study is to evaluate the safety andimmunogenicity of concomitant administration of EV71 vaccine manufactured by Sinovac (Beijing) Vaccine Technology Co., Ltd. with measles mumps, and rubella combined live attenuated vaccine/ encephalitis live attenuated vaccine. 360 healthy infants of 8 months old as participants are randomly assigned into three experimental groups in the ratio 1:1:1. The group I receive EV71 Vaccine (first dose)\&measles mumps, and rubella combined live attenuated vaccine on day 0 and EV71 vaccine (second dose)\&encephalitis live attenuated vaccine on day 30. The group II receive measles mumps, and rubella combined live attenuated vaccine on day 0 and encephalitis live attenuated vaccine on day 30. The group III receive the first and second dose of EV71 Vaccine on day 0 and day 30 respectively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
372
The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.# the MMR vaccine was manufactured by Shanghai Institute of Biological Products Co.,Ltd.; the Live attenuated Japanese encephalitis vaccine was manufactured by Chengdu Institute of Biological Products Co.,Ltd.
The MMR vaccine was manufactured by Shanghai Institute of Biological Products Co.,Ltd.; the Live attenuated Japanese encephalitis vaccine was manufactured by Chengdu Institute of Biological Products Co.,Ltd.
The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.
Hanbin District Center for Disease Control and Prevention
Ankang, Shaanxi, China
The seroconversion rates(SCR) of the EV71 neutralizing antibody 30 days after two dose of EV71 vaccines
Immunogenicity indicator
Time frame: 30 days after two dose of EV71 vaccines
The seroconversion rates(SCR) of the Measles IgG antibody,Rubella 30 IgG antibody and Mumps IgG antibody 60 days after one dose of MMR vaccine
Immunogenicity indicator
Time frame: 60 days after one dose of MMR vaccine
The seroconversion rates(SCR) of the Japanese encephalitis neutralizing antibody 30 days after one dose of Encephalitis B vaccine
Immunogenicity indicator
Time frame: 30 days after one dose of Encephalitis B vaccine
EV71 neutralizing antibody positive rate 30 days of two dose of EV71 vaccines
Immunogenicity indicator
Time frame: 30 days after two dose of EV71 vaccines
The Geometric mean titer (GMT) of the EV71 neutralizing antibody 30 days of two dose of EV71 vaccines
Immunogenicity indicator
Time frame: 30 days after two dose of EV71 vaccines
Measles IgG antibody,Rubella 30 IgG antibody and Mumps IgG antibody positive rate 60 days after one dose of MMR vaccine
Immunogenicity indicator
Time frame: 60 days after one dose of MMR vaccine
The Geometric mean titer (GMT) of Measles IgG antibody,Rubella 30 IgG antibody and Mumps IgG antibody 60 days after one dose of MMR vaccine
Immunogenicity indicator
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Time frame: 60 days after one dose of MMR vaccine
The Japanese encephalitis neutralizing antibody positive rate 30 days after one dose of Encephalitis B vaccine
Immunogenicity indicator
Time frame: 30 days after one dose of Encephalitis B vaccine
The Geometric mean titer (GMT) of Japanese encephalitis neutralizing antibody 30 days after one dose of Encephalitis B vaccine
Immunogenicity indicator
Time frame: 30 days after one dose of Encephalitis B vaccine
Incidence of solicited local or systemic adverse events within 7 days or 14 days after each dose
Safety indicator
Time frame: 7 days or 14 days after each dose of injection
The incidences of adverse reactions after each does
After each dose, a 30-minute safety observation will be conducted immediately. The body temperature, solicited local and general adverse events (AE) on day 0-7 or day 0-14 were reported. Unsolicited adverse events on day 0-30 were also reported.
Time frame: 0-30 days after each dose
Incidence of serious adverse events (SAEs) during the period of safety monitoring
Serious adverse events (SAEs) will be collected during the period of safety monitoring after each dose
Time frame: 0-30 days after each dose