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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 1, 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

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

Condition or disease Intervention/treatment Phase
Hand, Foot and Mouth Disease Biological: EV71 vaccine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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.
Actual Study Start Date : July 16, 2017
Actual Primary Completion Date : September 15, 2017
Actual Study Completion Date : September 15, 2017

Arm Intervention/treatment
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.
Biological: EV71 vaccine
Two doses vaccination of EV71vaccine (Intramuscular injection, 0.5ml) with a schedule of 0, 28 days.

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.
Biological: EV71 vaccine
Two doses vaccination of EV71vaccine (Intramuscular injection, 0.5ml) with a schedule of 0, 28 days.

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.
Biological: EV71 vaccine
Two doses vaccination of EV71vaccine (Intramuscular injection, 0.5ml) with a schedule of 0, 28 days.




Primary Outcome Measures :
  1. The seroconversion rate of EV71 neutralizing antibody 30 days after the two doses vaccination [ Time Frame: 30 days ]
    Immunogenicity indicator


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Incidence of unsolicited local or systemic adverse events within 3 days after each dose [ Time Frame: 3 days ]
    Safety indicator

  5. Incidence of unsolicited adverse events within 30 days after each dose [ Time Frame: 30 days ]
    Safety indicator

  6. Incidence of the serious adverse events within 60 days after the first dose vaccination [ Time Frame: 60 days ]
    Safety indicator



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 35 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03278132


Locations
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China, Zhejiang
Shangyu District Center for Disease Control and Prevention
Shaoxing, Zhejiang, China, 312300
Sponsors and Collaborators
Sinovac Biotech Co., Ltd
Zhejiang Provincial Center for Disease Control and Prevention
Shangyu District Center for Disease Control and Prevention
Investigators
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Principal Investigator: Huakun Lv Zhejiang Provincial Center for Disease Control and Prevention

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Responsible Party: Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT03278132     History of Changes
Other Study ID Numbers: PRO-EV71-4011
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: January 1, 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
Safety
Immunogenicity
Infant

Additional relevant MeSH terms:
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Mouth Diseases
Foot-and-Mouth Disease
Hand, Foot and Mouth Disease
Stomatognathic Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Coxsackievirus Infections
Enterovirus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs