A Randomized, Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With Recombinant Hepatitis B Vaccine/Group A Meningococcal Polysaccharide Vaccine
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Hand, Foot and Mouth Disease
- Sponsor
- Sinovac Biotech Co., Ltd
- Enrollment
- 780
- Locations
- 1
- Primary Endpoint
- The seropositive rate of EV71 neutralizing antibody, anti-HBs and serum bactericidal antibody 1 month after 2 doses of vaccination
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy volunteers aged 6 months
- •Finished two doses of vaccination (0,1 month) of hepatitis B vaccine prior to study entry
- •Proven legal identity
- •Guardian(s) of the volunteer should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study
Exclusion Criteria
- •Finished all the three doses vaccination (0,1,6 month) of hepatitis B vaccine prior to study entry
- •Prior vaccination of meningococcal polysaccharide vaccine
- •Prior vaccination of EV71 vaccine
- •Unable to receive vaccination on both arms
- •History of hand foot and mouth disease
- •Previously tested HBsAg positive
- •Mother of the subject had been previously tested HBsAg positive
- •History of asthma; history of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc
- •Congenital malformation, developmental disorders, genetic defects
- •Autoimmune disease or immunodeficiency/immunosuppressive
Outcomes
Primary Outcomes
The seropositive rate of EV71 neutralizing antibody, anti-HBs and serum bactericidal antibody 1 month after 2 doses of vaccination
Time Frame: 30 days after 2 doses of injection
Immunogenicity indicator
Secondary Outcomes
- Incidence of solicited local or systemic adverse events within 7 days after each dose(7 days after each dose of injection)
- Incidence of unsolicited local or systemic adverse events within 30 days after each dose(30 days after each dose of injection)
- Incidence of serious adverse events during the period of safety monitoring(60 days after the first dose injection)
- The seroconversion rate of EV71 neutralizing antibody, anti-HBs and serum bactericidal antibody(SBA) 1 month after 2 doses of vaccination(30 days after 2 doses of injection)
- EV71 neutralizing antibody GMT, anti-HBs GMC and SBA antibody GMT 1 month after 2 doses of vaccination(30 days after 2 doses of injection)