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Clinical Trial of Enterovirus 71(EV71) Inactivated Vaccine in Children Aged 36-71 Months

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ClinicalTrials.gov Identifier: NCT03909074
Recruitment Status : Completed
First Posted : April 9, 2019
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd

Tracking Information
First Submitted Date  ICMJE March 29, 2019
First Posted Date  ICMJE April 9, 2019
Last Update Posted Date January 21, 2020
Actual Study Start Date  ICMJE March 10, 2019
Actual Primary Completion Date June 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2019)
  • The seroconversion rates (SCR) of the EV71 neutralizing antibody calculated based on the cutoff value of 1:8 [ Time Frame: 30 days after two doses ]
    Subjects whose pre-immune antibody titer < 1:8 and post-immune antibody titer ≥ 1:8, or those whose pre-immune antibody titer ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted.
  • The Geometric mean titer (GMT) of the EV71 neutralizing antibody in the susceptible population [ Time Frame: 30 days after two doses ]
    The susceptible population refer to the subjects whose pre-immune antibody titer <1:8
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2019)
  • The overall incidence of adverse reactions [ Time Frame: 0-30 days after each dose ]
    After each dose, a 30-minute safety observation will be conducted immediately. The body temperature, solicited local and general adverse events (AE) on day 0-7 were reported. The solicited local symptoms include pain, induration, redness, swelling, rash, and pruritus. The solicited general adverse symptoms include allergy, fatigue, irritability, inappetence, vomiting, diarrhea, and fever. Unsolicited adverse events on day 0-30 were also reported, which include the unsolicited symptoms happened within 0-7 days, and any symptoms happened within the 8-28 days. Each AE case will be reviewed by the investigator to determine whether it was an adverse reaction (The vaccination-related AE). The incidence of adverse reactions=Number of subjects who have adverse reactions of any symptoms/number of all the subjects whose safety information are collected.
  • The incidence of the serious adverse events (SAE) [ Time Frame: 0-30 days after each dose ]
    After each dose, the serious adverse events in the safety observation period will be reported. The SAE incidence=Number of subjects who have SAE of any symptoms/Number of subjects whose safety information are collected.
  • The seroconversion rates (SCR) of the EV71 neutralizing antibody calculated based on the cutoff value of 1:16, 1:32, and 1:64 respectively [ Time Frame: 30 days after two doses ]
    Subjects whose pre-immune antibody titer <1:16(1:32/1:64) and post-immune antibody titer ≥1:16(1:32/1:64), or those whose pre-immune antibody titer ≥ 1:16(1:32/1:64) and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted.
  • The Geometric mean titer (GMT) of the EV71 neutralizing antibody [ Time Frame: 30 days after two doses ]
    The GMT 30 days after two doses.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Enterovirus 71(EV71) Inactivated Vaccine in Children Aged 36-71 Months
Official Title  ICMJE A Phase III Clinical Trial With Randomized, Double-blinded, Controlled Design as Well as Bridging Design to Evaluate the Safety and Immunogenicity of EV71 Vaccine in Children Aged 36-71 Months
Brief Summary The purpose of this study is to evaluate the non-inferiority of experimental EV71 vaccine compared to the control EV71 vaccine in children aged 36-71 months, to evaluate the non-inferiority of EV71 vaccine used in children aged 36-71 months compared to 6-35 months. The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd, and the control vaccine was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.
Detailed Description This study is a randomized, double-blind, single-center, controlled phase III clinical trial in children aged 36-71 months, and bridging trial between agegroup of 6-35 and 36-71 months. The purpose of this study is to evaluate the immunogenicity and safety of the experimental EV71 vaccine in children aged 36-71 months. The primary objective of this study is to evaluate the non-inferiority of experimental EV71 vaccine compared to the control EV71 vaccine in children aged 36-71 months, and the non-inferiority of EV71 vaccine used in children aged 36-71 months compared to 6-35 months. The secondary objective is to evaluate the safety of the experimental vaccine used in children aged 36-71 months. The experimental vaccine is manufactured by Sinovac Biotech Co., Ltd, and the control vaccine is manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences. 600 children aged 36-71 months will be randomly assigned in to receive the experimental vaccine or control vaccine, and 300 children aged 6-35 months will receive the experimental vaccine.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Hand, Foot and Mouth Disease
Intervention  ICMJE
  • Biological: 36-71 months old children-experimental EV71 vaccine.
    Two doses experimental EV71 vaccine at the 0, 30 days vaccination schedule.
  • Biological: 36-71 months old children-control EV71 vaccine.
    Two doses control EV71 vaccine at the 0, 30 days vaccination schedule.
  • Biological: 6-35 months old children-experimental EV71 vaccine.
    Two doses experimental EV71 vaccine at the 0, 30 days vaccination schedule.
Study Arms  ICMJE
  • Experimental: Experimental group
    36-71 months old children-experimental EV71 vaccine.
    Intervention: Biological: 36-71 months old children-experimental EV71 vaccine.
  • Active Comparator: Vaccine-controlled group
    36-71 months old children-control EV71 vaccine.
    Intervention: Biological: 36-71 months old children-control EV71 vaccine.
  • Active Comparator: Age-controlled group
    6-35 months old children-experimental EV71 vaccine.
    Intervention: Biological: 6-35 months old children-experimental EV71 vaccine.
Publications * Zhang L, Gao F, Zeng G, Yang H, Zhu T, Yang S, Meng X, Mao Q, Liu X. Immunogenicity and Safety of Inactivated Enterovirus 71 Vaccine in Children Aged 36-71 Months: A Double-Blind, Randomized, Controlled, Non-inferiority Phase III Trial. J Pediatric Infect Dis Soc. 2020 Dec 3. pii: piaa129. doi: 10.1093/jpids/piaa129. [Epub ahead of print]

*   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: April 8, 2019)
900
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 13, 2019
Actual Primary Completion Date June 17, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy volunteers ≥ 2 years old;
  • Proven legal identity;
  • Participants or guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment.

Exclusion Criteria:

  • Prior vaccination with EV71 vaccine;
  • History of hand, foot and mouth disease;
  • History of allergy to any vaccine or vaccine ingredient, asthma, serious adverse reactions to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;
  • Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
  • Autoimmune disease or immunodeficiency/immunosuppressive;
  • Severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness;
  • History of thyroidectomy, no spleen and functional spleen;
  • Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
  • Receipt of any of the following products:

    1. 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
    2. Blood products within 2 months prior to study entry
    3. Any other investigational products (drug or vaccine)within 30 days prior to study entry
    4. Any live attenuated vaccine within 14 days prior to study entry
    5. 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 °C;
  • Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 71 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 NCT03909074
Other Study ID Numbers  ICMJE PRO-EV71-3003-1
Has Data Monitoring Committee Not Provided
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 Not Provided
Investigators  ICMJE
Principal Investigator: Lifen Zhang, Master Yunnan Center for Disease Control and Prevention
PRS Account Sinovac Biotech Co., Ltd
Verification Date January 2020

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