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

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ClinicalTrials.gov Identifier: NCT03274102
Recruitment Status : Completed
First Posted : September 6, 2017
Last Update Posted : January 2, 2019
Sponsor:
Collaborators:
Guangdong Provincial Center for Disease Control and Prevention
Dongguan Municipal Center for Disease Control and Prevention
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hand, Foot and Mouth Disease Biological: Concomitant administration of EV71 vaccine with EPI vaccines Biological: Single injection of EPI vaccine Biological: EV71 Vaccine only Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 780 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: open-labelled
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : April 22, 2017
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : November 1, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
  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
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
  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
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
The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Incidence of solicited local or systemic adverse events within 7 days after each dose [ Time Frame: 7 days after each dose of injection ]
    Safety indicator

  2. Incidence of unsolicited local or systemic adverse events within 30 days after each dose [ Time Frame: 30 days after each dose of injection ]
    Safety indicator

  3. Incidence of serious adverse events during the period of safety monitoring [ Time Frame: 60 days after the first dose injection ]
    Safety indicator

  4. The seroconversion rate of EV71 neutralizing antibody, anti-HBs and serum bactericidal antibody(SBA) 1 month after 2 doses of vaccination [ Time Frame: 30 days after 2 doses of injection ]
    Immunogenicity indicator

  5. EV71 neutralizing antibody GMT, anti-HBs GMC and SBA antibody GMT 1 month after 2 doses of vaccination [ Time Frame: 30 days after 2 doses of injection ]
    Immunogenicity indicator


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 ℃
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274102


Locations
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China, Guangdong
Dongguan Municipal Center for Disease Control and Prevention
Dongguan, Guangdong, China, 523129
Sponsors and Collaborators
Sinovac Biotech Co., Ltd
Guangdong Provincial Center for Disease Control and Prevention
Dongguan Municipal Center for Disease Control and Prevention
Investigators
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Principal Investigator: Huizhen Zheng Guangdong Provincial Center for Disease Control and Prevention
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT03274102    
Other Study ID Numbers: PRO-EV71-4003
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: January 2, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sinovac Biotech Co., Ltd:
Inactivated Enterovirus Type 71 (EV71) Vaccine
Concomitant vaccination
Safety
Immunogenicity
Infant
Additional relevant MeSH terms:
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Foot-and-Mouth Disease
Hand, Foot and Mouth Disease
Mouth Diseases
Stomatognathic Diseases
Picornaviridae Infections
RNA Virus Infections
 Virus Diseases
Coxsackievirus Infections
Enterovirus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs