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Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With Expanded Programme on Immunization Vaccines

2019-10-07 08:56:49 | BioPortfolio

Summary

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.

Description

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 Design

Conditions

Hand, Foot and Mouth Disease

Intervention

Concomitant administration of EV71vaccine with EPI vaccines, Single injection of EPI vaccine, EV71 Vaccine only

Location

Hanbin District Center for Disease Control and Prevention
Ankang
Shaanxi
China
725000

Status

Recruiting

Source

Sinovac Biotech Co., Ltd

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-07T08:56:49-0400

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