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The Immunogenicity and Safety of the Vaccination of Inactivated Enterovirus 71 Vaccine and Seasonal Influenza Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04133584
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Collaborator:
China National Biotec Group Company Limited
Information provided by (Responsible Party):
Zhejiang Provincial Center for Disease Control and Prevention

Brief Summary:
The purpose of this study is to evaluate the Immunogenicity and safety of the simultaneously vaccination of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV)

Condition or disease Intervention/treatment Phase
Seasonal Influenza Hand, Foot and Mouth Disease Biological: EV71 +SIV Biological: EV71 Biological: SIV Phase 4

Detailed Description:

Main subjects:

The seroconversion rate for each antigen when EV71 is administrated with SIV

Secondary subjects:

The positive rate of antibody for each antigen when EV71 is administrated with SIV The safety for each antigen when EV71 is administrated with SIV

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Multiple Centers, Randomized, and Control Trail on the Immunogenicity and Safety of the Simultaneously Vaccination of Inactivated Enterovirus 71 Vaccine (EV71) and Seasonal Influenza Vaccine(SIV)
Actual Study Start Date : September 16, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Group 1 EV71 +SIV
Give 2 doses of Inactivated Enterovirus 71 Vaccine (EV71) and seasonal influenza vaccine(SIV) simultaneously with 28 days apart
Biological: EV71 +SIV
Give 2 doses of EV71 +SIV, get 2 blood samples before the first dose and 28-43 days after the last dose.

Active Comparator: Group 2 EV71
Give 2 doses of Inactivated Enterovirus 71 Vaccine (EV71) with 28 days apart
Biological: EV71
Give 2 doses of EV71 , get 2 blood samples before the first dose and 28-43 days after the last

Active Comparator: Group 3 SIV
Give 2 doses of seasonal influenza vaccine(SIV) simultaneously with 28 days apart
Biological: SIV
Give 2 doses of SIV , get 2 blood samples before the first dose and 28-43 days after the last




Primary Outcome Measures :
  1. immunogenicity evaluation [ Time Frame: change from baseline antibody concentration at 28 days after the last dose ]
    The positive rate of antibody


Secondary Outcome Measures :
  1. safety evaluation: The occurrence of adverse events [ Time Frame: up to 30 days after every injection ]
    The occurrence of adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 11 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent.
  • Participant is aged ≥ 6 month to <12 months.
  • Participant without preventive inoculation of Enterovirus 71 Vaccine ,seasonal influenza vaccine vaccine and previous history of Enterovirus.
  • Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures.
  • Body temperature ≤ 37.0#.

Exclusion Criteria:

  • Known allergy to any constituent of the vaccine.

    • Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever.
    • Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth.
    • Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction.
    • Known bleeding disorder.
    • Receipt of the whole blood, blood plasma or immunoglobulin before the trial vaccination.
    • Reported the history of acute illness had need systemic antibiotics or antiviral treatment of infections in the 7 days preceding the trial vaccination.
    • An acute illness with or without fever (temperature ≥ 38.0#) in the 3 days preceding enrollment in the trial.
    • Participation in any other intervention clinical trial.
    • Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine.

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): NCT04133584


Contacts
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Contact: Chen Yaping, Master +86-571-87115172 ypchen@cdc.zj.cn

Locations
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China, Zhejiang
Liandu Center for Disease Control and Prevention Recruiting
Lishui, Zhejiang, China
Contact: chen yaping, master    86-571-87115172    ypchen@cdc.zj   
Sponsors and Collaborators
Zhejiang Provincial Center for Disease Control and Prevention
China National Biotec Group Company Limited
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Responsible Party: Zhejiang Provincial Center for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT04133584    
Other Study ID Numbers: ZJCDC20190918
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Zhejiang Provincial Center for Disease Control and Prevention:
Immunogenicity
Safety
Enterovirus 71 Vaccine
seasonal influenza vaccine
Additional relevant MeSH terms:
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Influenza, Human
Enterovirus Infections
Foot-and-Mouth Disease
Hand, Foot and Mouth Disease
Mouth Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Picornaviridae Infections
Stomatognathic Diseases
Coxsackievirus Infections