Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With EPI Vaccines
Condition: Hand, Foot and Mouth Disease
MeSH terms: Foot-and-Mouth Disease; Hand, Foot and Mouth Disease; Mouth Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of concomitant
      administration of EV71 vaccine with recombinant hepatitis B vaccine/Group A meningococcal
      polysaccharide vaccine.
    

Detailed 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 and immunogenicity of concomitant
      administration of EV71 vaccine manufactured by Sinovac (Beijing) Vaccine Technology Co., Ltd.
      with recombinant hepatitis B vaccine/Group A meningococcal polysaccharide vaccine. 780
      healthy infants of 6 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)& recombinant
      hepatitis B vaccine on day 0 and EV71 vaccine (second dose)& Group A meningococcal
      polysaccharide vaccine on day 30. The group II receive recombinant hepatitis B vaccine on day
      0 and Group A meningococcal polysaccharide vaccine on day 30. The group III receive the first
      and second dose of EV71 Vaccine on day 0 and day 30 respectively.
    

Intervention name(s): Concomitant administration of EV71 vaccine with EPI vaccines; Single injection of EPI vaccine; EV71 Vaccine only
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 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.
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; 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.
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; The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Inactivated Enterovirus Type 71 (EV71) Vaccine; Concomitant vaccination; Safety; Immunogenicity; Infant