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CompletedNCT03274102Updated Jul 29, 2021

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

A Phase 4 interventional study of Concomitant administration of EV71 vaccine with EPI vaccines and Single injection of EPI vaccine in Hand, Foot and Mouth Disease, sponsored by Sinovac Biotech Co., Ltd. Completed at 1 site in China. Open to participants aged 6 Months to 6 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-29.

Sponsored by Sinovac Biotech Co., Ltd · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
780
Allocation
Randomized
Ages
6 Months to 6 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hand, Foot and Mouth Disease

Keywords

  • Inactivated Enterovirus Type 71 (EV71) Vaccine
  • Concomitant vaccination
  • Safety
  • Immunogenicity
  • Infant
03

Who can participate

Ages eligible
6 Months to 6 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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
  • 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

Exclusion Criteria of the Second Injection:

  • Subjects with one of the following 1 to 3 conditions are forbidden to continue vaccination, while the other study steps could be carried out based on the judgement of investigator; for subjects with one of the following 4 to 5 conditions, whether to continue vaccination are determined by the investigator; for subjects with one of the following 6 to 7 conditions, vaccination may be delayed in the time window specified in the study:

    1. Any serious adverse event that has a causal relationship with the investigated vaccine (except the group II)
    2. Severe allergic reactions or hypersensitivity after vaccination (including urticaria / rash appear within 30 minutes after vaccination, except the group II )
    3. Any confirmed or suspected autoimmune disease or immunodeficiency disease (e.g., HIV infection)
    4. New chronic diseases or acute stage of chronic diseases
    5. Other reactions (including severe pain, severe swelling, severe activity limitation, persistent hyperthermia, severe headache or other systemic or local reactions) determined by the investigators
    6. Acute diseases (moderate or severe diseases with or without fever)
    7. Axillary temperature> 37.0 ℃
04

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
780 participants (actual)

Study arms

  • Experimental
    Group I-EV71 vaccine and EPI vaccines

    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

  • Active comparator
    Group II-EPI vaccine only

    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

  • Active comparator
    Group III-EV71 vaccine only

    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

  • 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.

05

What researchers measure

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

    Time frame: 30 days after 2 doses of injection

Secondary outcomes

  1. Incidence of solicited local or systemic adverse events within 7 days after each dose

    Safety indicator

    Time frame: 7 days after each dose of injection

  2. Incidence of unsolicited local or systemic adverse events within 30 days after each dose

    Safety indicator

    Time frame: 30 days after each dose of injection

  3. Incidence of serious adverse events during the period of safety monitoring

    Safety indicator

    Time frame: 60 days after the first dose injection

  4. The seroconversion rate of EV71 neutralizing antibody, anti-HBs and serum bactericidal antibody(SBA) 1 month after 2 doses of vaccination

    Immunogenicity indicator

    Time frame: 30 days after 2 doses of injection

  5. EV71 neutralizing antibody GMT, anti-HBs GMC and SBA antibody GMT 1 month after 2 doses of vaccination

    Immunogenicity indicator

    Time frame: 30 days after 2 doses of injection

06

Study locations

1 site
  • Dongguan Municipal Center for Disease Control and Prevention
    Dongguan, Guangdong 523129, China
07

References and documents

Publications

  • 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. PubMed 30891604 ↗
08

Registry details

Key details

Study ID
NCT03274102
Lead sponsor
Sinovac Biotech Co., Ltd
Collaborators
Guangdong Center for Disease Prevention and Control
Responsible party
Sponsor
First posted
Sep 6, 2017
Start date
Apr 22, 2017
Primary completion
Nov 1, 2017
Completion
Nov 1, 2017
Last update
Jul 29, 2021

Study contacts

Huizhen Zheng
principal investigator · Guangdong Center for Disease Prevention and Control

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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