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Phase IV Clinical Trial, Immunogenicity and Safety of EV71 Vaccine

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ClinicalTrials.gov Identifier: NCT03278132
Recruitment Status : Completed
First Posted : September 11, 2017
Last Update Posted : January 2, 2019
Sponsor:
Collaborators:
Zhejiang Provincial Center for Disease Control and Prevention
Shangyu District Center for Disease Control and Prevention
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd

Tracking Information
First Submitted Date  ICMJE September 7, 2017
First Posted Date  ICMJE September 11, 2017
Last Update Posted Date January 2, 2019
Actual Study Start Date  ICMJE July 16, 2017
Actual Primary Completion Date September 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
The seroconversion rate of EV71 neutralizing antibody 30 days after the two doses vaccination [ Time Frame: 30 days ]
Immunogenicity indicator
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2017)
The seropositive and seroconversion rate of EV71 neutralizing antibody 30 days after the two doses vaccination [ Time Frame: 30 days ]
Immunogenicity indicator
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
  • The seroconversion rate of EV71 neutralizing antibody 10, 20 and 30 days after the first dose vaccination [ Time Frame: 10,20,and 30 days ]
    Immunogenicity indicator
  • The seropositive rate of EV71 neutralizing antibody 10, 20, 30, and 60 days after the first dose vaccination [ Time Frame: 10, 20,30,and 60 days ]
    Immunogenicity indicator
  • GMT and GMT increase fold of EV71 neutralizing antibody 10,20,30,and 60 days after the first dose vaccination [ Time Frame: 10,20,30,and 60 days ]
    Immunogenicity indicator
  • Incidence of unsolicited local or systemic adverse events within 3 days after each dose [ Time Frame: 3 days ]
    Safety indicator
  • Incidence of unsolicited adverse events within 30 days after each dose [ Time Frame: 30 days ]
    Safety indicator
  • Incidence of the serious adverse events within 60 days after the first dose vaccination [ Time Frame: 60 days ]
    Safety indicator
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2017)
  • The seropositive and seroconversion rate of EV71 neutralizing antibody 10, 20 and 30 days after the first dose vaccination [ Time Frame: 10,20,and 30 days ]
    Immunogenicity indicator
  • GMT and GMT increase fold of EV71 neutralizing antibody 10,20,30,and 60 days after the first dose vaccination [ Time Frame: 10,20,30,and 60 days ]
    Immunogenicity indicator
  • Incidence of unsolicited local or systemic adverse events within 3 days after each dose [ Time Frame: 3 days ]
    Safety indicator
  • Incidence of unsolicited adverse events within 30 days after each dose [ Time Frame: 30 days ]
    Safety indicator
  • Incidence of the serious adverse events within 60 days after the first dose vaccination [ Time Frame: 60 days ]
    Safety indicator
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase IV Clinical Trial, Immunogenicity and Safety of EV71 Vaccine
Official Title  ICMJE A Phase IV Open-labelled, Single-centered, Stratified-randomized Clinical Trial in Zhejiang Province to Evaluate the Safety and Immunogenicity of EV71 Vaccine Developed by Sinovac Biotech Co., Ltd.
Brief Summary The purpose of this study is to evaluate the immunogenicity and safety of EV71 vaccine in infants aged 6 to 35 months old, by detecting the dynamic changes of neutralizing antibody at different time after vaccination
Detailed Description This study is an open-labelled, single-centered, stratified-randomized, phase IV clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of EV71 vaccine (developed by Sinovac Biotech Co., Ltd.) in infants aged 6 to 35 months old, by detecting the dynamic changes of neutralizing antibody at different times after vaccination. The enrolled subjects in this study receive two doses of EV71 vaccine with 1-month interval between doses. To evaluate safety of the vaccine, subjects will be observed for 30 days after the injection for the potential adverse events. To evaluate the immunogenicity of the vaccine, venous blood will be collected for the neutralizing antibody detection prior to vaccination, 10/20/30 days after the 1st dose and 30 days after the 2nd dose vaccination. All subjects will receive blood sampling for three times. Subjects will be randomly assigned to receive blood sampling at 10/20/30 days after 1st dose injection, with a ratio of 1: 1: 1.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Hand, Foot and Mouth Disease
Intervention  ICMJE Biological: EV71 vaccine
Two doses vaccination of EV71vaccine (Intramuscular injection, 0.5ml) with a schedule of 0, 28 days.
Study Arms  ICMJE
  • Experimental: EV71 vaccine & blood sampling (0, 10,60)
    This group receive two doses injection of EV71 vaccine (0, 28 days), and three times of blood sampling on day of 0, 10, and 60 respectively for EV71 neutralizing antibody detection.
    Intervention: Biological: EV71 vaccine
  • Experimental: EV71 vaccine & blood sampling (0, 20,60)
    This group receive two doses injection of EV71 vaccine (0, 28 days), and three times of blood sampling on day of 0, 20, and 60 respectively for EV71 neutralizing antibody detection.
    Intervention: Biological: EV71 vaccine
  • Experimental: EV71 vaccine& blood sampling (0, 30, 60)
    This group receive two doses injection of EV71 vaccine (0, 28 days), and three times of blood sampling on day of 0, 30, and 60 respectively for EV71 neutralizing antibody detection.
    Intervention: Biological: EV71 vaccine
Publications * Wang S, Zeng J, Zhang X, Gan Z, Fan J, Chen Y, Liang Z, Hu X, Zeng G, Lv H. Short-term dynamic changes in neutralizing antibodies against enterovirus 71 after vaccination. Hum Vaccin Immunother. 2020 Jul 2;16(7):1595-1601. doi: 10.1080/21645515.2020.1711678. Epub 2020 Jan 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 7, 2017)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 15, 2017
Actual Primary Completion Date September 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy volunteers aged 6-35 months old
  • 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
  • Proven legal identity

Exclusion Criteria:

For subjects with any of the following conditions, vaccination should not be administrated:

  • History of hand foot and mouth disease
  • Allergy to gentamicin; history of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, pain, etc
  • Severe chronic diseases
  • Thrombocytopenia or hemorrhagic disease
  • Immunodeficiency disease or receipt of immunosuppressant treatment
  • Uncontrolled epilepsy or progressive neurological disorders(e.g. Guillain-Barre syndrome)
  • Acute disease or acute stage of chronic disease prior to the study entry
  • History of thyroidectomy, thyroid disease within 12 months prior to the study entry
  • Asplenia or functional asplenia
  • Axillary temperature >37.0 ℃
  • Any other factor that suggesting the volunteer is unsuitable for this study based on the judgment of investigators

Exclusion Criteria of the Second Injection:

  • Subjects with any of the following conditions are forbidden to continue the 2nd dose of vaccination:

    1. Any serious adverse event that has a causal relationship with the investigated vaccine
    2. Severe allergic reactions or hypersensitivity after vaccination (including urticaria / rash appear within 30 minutes after vaccination
    3. Any confirmed or suspected autoimmune disease or immunodeficiency disease (e.g., HIV infection)
    4. Other reactions (including severe pain, severe swelling, severe activity limitation, persistent hyperthermia, severe headache or other systemic or local reactions)determined by the investigators
  • For subjects suffering from acute disease or acute stage of chronic disease , whether to continue vaccination depends on themselves
  • Subjects with the following conditions may receive vaccination in delayed time or withdraw from the study depending on the judgment of investigator

    1. Acute disease (moderate or severe disease with or without fever) in case of vaccination
    2. Axillary temperature > 37.0 °C
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 35 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03278132
Other Study ID Numbers  ICMJE PRO-EV71-4011
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sinovac Biotech Co., Ltd
Study Sponsor  ICMJE Sinovac Biotech Co., Ltd
Collaborators  ICMJE
  • Zhejiang Provincial Center for Disease Control and Prevention
  • Shangyu District Center for Disease Control and Prevention
Investigators  ICMJE
Principal Investigator: Huakun Lv Zhejiang Provincial Center for Disease Control and Prevention
PRS Account Sinovac Biotech Co., Ltd
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP