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Evaluation of the Safety and Immunogenicity of Simultaneously Administration of EV71 Vaccine and 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: NCT04091880
Recruitment Status : Not yet recruiting
First Posted : September 17, 2019
Last Update Posted : September 17, 2019
Sponsor:
Collaborators:
Zhejiang Provincial Center for Disease Control and Prevention
Henan Center for Disease Control and Prevention
Guizhou Center for Disease Control and Prevention
Wuhan Institute of Biological Products Co., Ltd
Changchun Institute of Biological Products Co., Ltd.
Peking University
National Institutes for Food and Drug Control, China
Information provided by (Responsible Party):
China National Biotec Group Company Limited

Brief Summary:

Subjects will be recruited and divided into 3 groups:

  1. Experimental Group (378 subjects): combined immunization of EV71 vaccine and influenza vaccine;
  2. Control Group A (378 subjects): EV71 vaccine only;
  3. Control Group B (378 subjects): influenza vaccine only;

All blood samples will be collected before and one month after vaccinatioin. The immunogenicity and safety of both experimental and control groups will be compared and the data be analyzed.


Condition or disease Intervention/treatment Phase
Enterovirus Infections Influenza Biological: EV71 vaccine and influenza vaccine Biological: EV71 vaccine Biological: influenza vaccine Phase 4

Detailed Description:

To further evaluate the feasibility of simultaneously administration of EV71 vaccine and flu vaccine, we design this clinical trial to test its immunogenicity and safety. 1134 subjects aged from 6 to 11 months old are divided into one experimental group and two control groups (control group A and B).

Each group includes 378 subjects and is divided again into 3 age-based subgroups: ① 6-7 months old; ② 8-9 months old; ③10-11 months old ; each subgroup has 126 subjects respectively.

378 subjects from the experimental group will be simultaneously administrated with one dose of EV71 vaccine (0.5 ml) and one dose of influenza vaccine (0.25 ml). One month later, they are going to receive a second dose of EV71 vaccine and influenza vaccine, simultaneously. Blood samples are collected before the first vaccination, and one month following the second vaccination.

378 subjects from the control group A will be only administrated with two doses of EV71 vaccine (0.5 ml) (1 month apart). Blood samples are collected before the first vaccination, and one month following the second vaccination.

378 subjects from the control group B will be only administrated with two doses of influenza vaccine (0.25 ml) (1 month apart). Blood samples are collected before the first vaccination, and one month following the second vaccination.

To evaluate the immunogenicity, we will detect and compare the neutralization antibody levels, the seroprotection rates, and antibody geometric mean concentrations. The safety of all groups will be monitored as well.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Safety and Immunogenicity of Simultaneously Administration of EV71 Vaccine and Influenza Vaccine (Split Virion),Inactivated
Estimated Study Start Date : September 16, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: experimental group
378 subjects from the experimental group will be simultaneously administrated with one dose of EV71 vaccine (0.5 ml) and one dose of influenza vaccine (0.25 ml). One month later, they are going to receive a second dose of EV71 vaccine and influenza vaccine, simultaneously.
Biological: EV71 vaccine and influenza vaccine
simultaneously administrated with EV71 vaccine and influenza vaccine

Active Comparator: control group A
378 subjects from the control group A will be only administrated with two doses of EV71 vaccine (0.5 ml) (1 month apart).
Biological: EV71 vaccine
administrated with EV71 vaccine only

Active Comparator: control group B
378 subjects from the control group B will be only administrated with two doses of influenza vaccine (0.25 ml) (1 month apart).
Biological: influenza vaccine
administrated with influenza vaccine only




Primary Outcome Measures :
  1. Seroconversion rate I [ Time Frame: Baseline (before vaccination) and 1 month after the last dose ]
    the rate of positive seroconversion against EV71

  2. Seroconversion rate II [ Time Frame: Baseline (before vaccination ) and 1 month after the last dose ]
    the rate of positive seroconversion against Influenza A (H3N2, H1N1) and B Type viruses

  3. Geometric mean titer (GMT) I [ Time Frame: Baseline (before vaccination) and 1 month after the last dose ]
    Measure neutralizing antibody titers against EV71

  4. Geometric mean titer (GMT) II [ Time Frame: Baseline (before vaccination) and 1 month after the last dose ]
    Measure neutralizing antibody titers against Influenza A (H3N2, H1N1) and B Type viruses


Secondary Outcome Measures :
  1. adverse events following vaccination [ Time Frame: 6 months ]
    analyse the numbers and rates of participants who experience adverse events following immunization



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:   Yes
Criteria

Inclusion Criteria:

  • subjects aged from 6-11 months old at the date of recruitment;
  • with informed consent signed by parent(s) or guardians;
  • parent(s) or guardians are able to attend all planned clinical appointments and comply with all study instructions;
  • subjects not receive any vaccination within 14 days at the date of recruitment;
  • subjects have not been vaccinated with EV71 vaccine, seasonal flu vaccine;
  • subjects with no medical history of EV71 infection;
  • axillary temperature ≤37.0℃

Exclusion Criteria:

  • subject who has a medical history with Hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness;
  • allergic to any ingredient of vaccine or with allergy history to any vaccine;
  • subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone);
  • administration of immunoglobulins within 30 days prior to this study;
  • acute febrile disease(temperature ≥ 37.0°C) or infectious disease;
  • have a clearly diagnosed history of thrombocytopenia or other coagulopathy,
  • may cause contraindications for subcutaneous injection;
  • any serious chronic illness, acute infectious diseases, or respiratory diseases;
  • severe cardiovascular disease, liver and kidney diseases or diabetes mellitus with complications;
  • any kind of infectious, purulent, or allergic skin diseases;
  • any other factor that makes the investigator determines the subject is unsuitable for this study.

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): NCT04091880


Contacts
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Contact: Hanqing He +86-571-87115170 hanqinghe@cdc.zj.cn
Contact: Ying Ye 13949006519

Sponsors and Collaborators
China National Biotec Group Company Limited
Zhejiang Provincial Center for Disease Control and Prevention
Henan Center for Disease Control and Prevention
Guizhou Center for Disease Control and Prevention
Wuhan Institute of Biological Products Co., Ltd
Changchun Institute of Biological Products Co., Ltd.
Peking University
National Institutes for Food and Drug Control, China
Investigators
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Principal Investigator: Hanqing He Zhejiang Provincial Center for Disease Control and Prevention
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Responsible Party: China National Biotec Group Company Limited
ClinicalTrials.gov Identifier: NCT04091880    
Other Study ID Numbers: EV71-Flu-Combine-01
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 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 China National Biotec Group Company Limited:
EV71 vaccine
influenza vaccine
simultaneously administration
Additional relevant MeSH terms:
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Influenza, Human
Enterovirus Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Picornaviridae Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs