Hand, Foot and Mouth Disease
Conditions
Keywords
Inactivated Enterovirus Type 71 (EV71) Vaccine, Concomitant vaccination, Safety, Immunogenicity, Infant
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.
Interventions
BIOLOGICALConcomitant 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
BIOLOGICALSingle 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
BIOLOGICALEV71 Vaccine only
The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.
Sponsors
Guangdong Center for Disease Prevention and Control
Sinovac Biotech Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
open-labelled
Eligibility
Sex/Gender
ALL
Age
6 Months to 6 Months
Healthy volunteers
Yes
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 * Severe nervous system disease or mental illness * Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders * Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within 6 month prior to study entry * Receipt of blood product (e.g., immunoglobulin) within 3 months prior to study entry * Receipt of any other investigational medicine(s) within 30 days prior to study entry * Receipt of any live attenuated vaccine within 14 days prior to study entry * Receipt of any subunit vaccine or inactivated vaccine within 7 days prior to study entry * Acute disease or acute stage of chronic disease within 7 days prior to study entry * Axillary temperature \> 37.0 ℃ * Any other factor that suggesting the volunteer is unsuitable for this study based on the judgement of investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The seropositive rate of EV71 neutralizing antibody, anti-HBs and serum bactericidal antibody 1 month after 2 doses of vaccination | 30 days after 2 doses of injection | Immunogenicity indicator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of solicited local or systemic adverse events within 7 days after each dose | 7 days after each dose of injection | Safety indicator |
| Incidence of unsolicited local or systemic adverse events within 30 days after each dose | 30 days after each dose of injection | Safety indicator |
| Incidence of serious adverse events during the period of safety monitoring | 60 days after the first dose injection | Safety indicator |
| 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 | Immunogenicity indicator |
| 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 | Immunogenicity indicator |
Countries
China
Outcome results
None listed