Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With EPI Vaccines

PHASE4CompletedINTERVENTIONAL
Enrollment

780

Participants

Timeline

Start Date

April 22, 2017

Primary Completion Date

November 1, 2017

Study Completion Date

November 1, 2017

Conditions
Hand, Foot and Mouth Disease
Interventions
BIOLOGICAL

Concomitant administration of EV71 vaccine with EPI vaccines

"1. The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.; the recombinant hepatitis B vaccine was manufactured by Shenzhen Kangtai Biological Products Co., Ltd; the Group A meningococcal polysaccharide vaccine was manufactured by Wuhan Institute of Biological Products Co., Ltd.~2. The primary vaccination schedule of hepatitis B vaccine includes 3 doses with a schedule of 0,1,6 month, and subjects only receive 3rd vaccination in this study; the primary vaccination schedule of Group A meningococcal polysaccharide vaccine includes 2 doses with 3 months interval between doses, and subjects only receive 1st vaccination in this study"

BIOLOGICAL

Single injection of EPI vaccine

"1. The recombinant hepatitis B vaccine was manufactured by Shenzhen Kangtai Biological Products Co., Ltd; the Group A meningococcal polysaccharide vaccine was manufactured by Wuhan Institute of Biological Products Co., Ltd.~2. The primary vaccination schedule of hepatitis B vaccine includes 3 doses with a schedule of 0,1,6 month, and subjects only receive 3rd vaccination in this study; the primary vaccination schedule of Group A meningococcal polysaccharide vaccine includes 2 doses with 3 months interval between doses, and subjects only receive 1st vaccination in this study"

BIOLOGICAL

EV71 Vaccine only

The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.

Trial Locations (1)

523129

Dongguan Municipal Center for Disease Control and Prevention, Dongguan

All Listed Sponsors
collaborator

Guangdong Center for Disease Prevention and Control

OTHER_GOV

lead

Sinovac Biotech Co., Ltd

INDUSTRY

NCT03274102 - Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With EPI Vaccines | Biotech Hunter | Biotech Hunter