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

NCT03274102 | Completed Phase 4

• 1 other identifier: PRO-EV71-4003
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand, Foot and Mouth Disease

Keywords

Inactivated Enterovirus Type 71 (EV71) Vaccine; Concomitant vaccination; Safety; Immunogenicity; Infant

Outcome Measures

Primary Outcomes (1)

• The seropositive rate of EV71 neutralizing antibody, anti-HBs and serum bactericidal antibody 1 month after 2 doses of vaccination

  Immunogenicity indicator

  30 days after 2 doses of injection

Secondary Outcomes (5)

• 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

Study Arms (3)

Group I-EV71 vaccine and EPI vaccines

EXPERIMENTAL

Concomitant administration of EV71 vaccine with EPI vaccines: EV71 Vaccine (intramuscular injection,0.5ml,first dose)/recombinant hepatitis B vaccine（intramuscular injection,0.5ml）on day 0 and EV71 Vaccine (injection, 0.5ml,second dose)/ Group A meningococcal polysaccharide vaccine(subcutaneous injection, 150ug) on day 30.

Biological: Concomitant administration of EV71 vaccine with EPI vaccines

Group II-EPI vaccine only

ACTIVE COMPARATOR

Single injection of EPI vaccine: recombinant hepatitis B vaccine (intramuscular injection, 0.5ml) on day 0 and Group A meningococcal polysaccharide vaccine (subcutaneous injection,150ug) on day 30.

Biological: Single injection of EPI vaccine

Group III-EV71 vaccine only

ACTIVE COMPARATOR

EV71 Vaccine only: the first and second dose of EV71 Vaccine (intramuscular injection,0.5ml) on day 0 and day 30 respectively.

Biological: EV71 Vaccine only

Interventions

Concomitant administration of EV71 vaccine with EPI vaccines BIOLOGICAL

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

Group I-EV71 vaccine and EPI vaccines

Single injection of EPI vaccine BIOLOGICAL

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

Group II-EPI vaccine only

EV71 Vaccine only BIOLOGICAL

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

Group III-EV71 vaccine only

Eligibility Criteria

• Age: 6 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead
• Guangdong Center for Disease Prevention and Control: collaborator

Study Sites (1)

Dongguan Municipal Center for Disease Control and Prevention

Dongguan, Guangdong, 523129, China

Location

Related Publications (1)

• Zhang Z, Liang Z, Zeng J, Zhang J, He P, Su J, Zeng Y, Fan R, Zhao D, Ma W, Zeng G, Zhang Q, Zheng H. Immunogenicity and Safety of an Inactivated Enterovirus 71 Vaccine Administered Simultaneously With Hepatitis B Vaccine and Group A Meningococcal Polysaccharide Vaccine: A Phase 4, Open-Label, Single-Center, Randomized, Noninferiority Trial. J Infect Dis. 2019 Jul 2;220(3):392-399. doi: 10.1093/infdis/jiz129.

  PMID: 30891604 DERIVED

MeSH Terms

Conditions

Hand, Foot and Mouth Disease

Condition Hierarchy (Ancestors)

Coxsackievirus Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Huizhen Zheng

  Guangdong Center for Disease Prevention and Control

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open-labelled
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 6, 2017
• Study Start: April 22, 2017
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: July 29, 2021

Record last verified: 2018-12

Locations

CN (1)