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Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (7.5μg/0.25ml)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859141
Recruitment Status : Completed
First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd

Brief Summary:
The purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy children aged 6-35 months.

Condition or disease Intervention/treatment Phase
Seasonal Influenza Biological: Quadrivalent influenza vaccine Biological: Trivalent influenza vaccine (contains B/Victoria strain) Biological: Trivalent influenza vaccine (contains B/Yamagata strain) Phase 3

Detailed Description:
The study includes open-labelled phase I and randomized, double-blind, controlled phase III clinical trial. In the phase I, 20 healthy Chinese children aged 6-35 months were administered with two doses of QIV (7.5μg/0.25ml). In the phase Ⅲ clinical trial, 2320 children were assigned to QIV group, TIV (B/Victoria) group and TIV (B/Yamagata) group in a 2:1:1 ratio. All vaccines were manufactured by Sinovac Biotech Co., Ltd.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The phase Ⅰ clinical trial was a single arm.The phase Ⅲ was 3 parallel arms.
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Open Phase I and Randomized, Double-blind, Controlled Phase III Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6-35 Months
Actual Study Start Date : February 6, 2018
Actual Primary Completion Date : April 17, 2018
Actual Study Completion Date : November 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Experimental group-phase Ⅰ
Quadrivalent influenza vaccine
Biological: Quadrivalent influenza vaccine
One dose of quadrivalent influenza vaccine: 0.25 ml per dose containing 7.5μg antigen.

Experimental: Experimental group-phase Ⅲ
Quadrivalent influenza vaccine
Biological: Quadrivalent influenza vaccine
One dose of quadrivalent influenza vaccine: 0.25 ml per dose containing 7.5μg antigen.

Active Comparator: Control group 1-phase Ⅲ
Trivalent influenza vaccine (contains B/Victoria strain)
Biological: Trivalent influenza vaccine (contains B/Victoria strain)
One dose of trivalent influenza vaccine (contains B/Victoria strain): 0.25 ml per dose containing 7.5μg antigen.

Active Comparator: Control group 2-phase Ⅲ
Trivalent influenza vaccine (contains B/Yamagata strain)
Biological: Trivalent influenza vaccine (contains B/Yamagata strain)
One dose of trivalent influenza vaccine (contains B/Yamagata strain): 0.25 ml per dose containing 7.5μg antigen.




Primary Outcome Measures :
  1. The lower limit of 95% confidence intervals (95%CI) of geometric mean titer (GMT) ratio (experimental group/control group) of hemagglutination inhibition (HI) antibody titer≥2/3. [ Time Frame: 28 days after two doses immunization ]
    Immunogenicity index, One of the standard to evaluate the experimental vaccine is non-inferior to the control vaccines.

  2. The lower limit of 95% CI of the seroconversion rate difference (experimental group-control group)≥-10%. [ Time Frame: 28 days after two doses immunization ]
    Immunogenicity index, Another standard to evaluate the experimental vaccine is non-inferior to the control vaccines.


Secondary Outcome Measures :
  1. The lower limit of 95%CI of the ratio of GMT (experimental group/control group) >1.5. [ Time Frame: 28 days after two doses immunization ]
    Immunogenicity index, One of the standard to evaluate the experimental vaccine is superior to the control vaccines for specific antigen type.

  2. The lower limit of 95% CI of the difference of HI antibody seroconversion rate (experimental group-control group)>10% [ Time Frame: 28 days after two doses immunization ]
    Immunogenicity index, Another standard to evaluate the experimental vaccine is superior to the control vaccines for specific antigen type.

  3. The lower limit of 95% CI of seroconversion rate for each HI antibody after two doses immunization≥40%. [ Time Frame: 28 days after two doses immunization ]
    Immunogenicity index

  4. The seroprotective rate (HI antibody titer≥1:40) of each HI antibody after two doses immunization≥70%. [ Time Frame: 28 days after two doses immunization ]
    Immunogenicity index

  5. The geometric mean increase (GMI) of each HI antibody after two doses immunization >2.5. [ Time Frame: 28 days after two doses immunization ]
    Immunogenicity index

  6. The lower limit of 95%CI of the ratio of GMT(experimental group/control group)≥2/3, in the subjects whose pre-immune HI antibody titer<1:40 [ Time Frame: 28 days after two doses immunization ]
    Immunogenicity index

  7. The lower limit of 95% CI of the difference of HI antibody seroconversion rate (experimental group-control group)≥-10%, in the subjects whose pre-immune HI antibody titer<1:40. [ Time Frame: 28 days after two doses immunization ]
    Immunogenicity index

  8. The incidence of the solicited local and general adverse reactions 0-7 days after each immunization. [ Time Frame: 0-7 days ]
    Safety index, The adverse reactions refers to the adverse events which were considered related to the vaccination.

  9. The incidence of the unsolicited adverse events 0-28 days after each immunization [ Time Frame: 0-28 days after each dose immunization ]
    Safety Index

  10. The incidence of the serious adverse events within 7 months after the first immunization. [ Time Frame: Within 7 months after the first dose immunization ]
    Safety Index



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 volunteer between 6 - 35 months old; Term birth; Birth weight >2500g;
  • Proven legal identity;
  • Written consent of the guardian(s) of the volunteer;

Exclusion Criteria:

  • Received seasonal influenza vaccine in the current year;
  • Suffering from seasonal influenza in the past 6 moths;
  • Axillaty temperature > 37.0 °C;
  • History of allergy to any vaccine or vaccine ingredient;
  • History of serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
  • Autoimmune disease or immunodeficiency;
  • Congenital malformation, developmental disorders;
  • Severe malnutrition;
  • Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
  • History of epilepsy (except febrile seizures occurred < 2 years of age or pure epilepsy occurred within the past 3 years that does not need treatment)
  • Chronic diseases (e.g., viral hepatitis, tuberculosis, diabetes, blood diseases, or neurological disorders)
  • Acute disease or acute stage of chronic disease;
  • Receipt of any of the following products:

    1. Any subunit vaccine or inactivated vaccine (e.g., pneumococcal vaccine) or treatment of allergy within 14 days prior to study entry;
    2. Any live attenuated vaccine within 30 days prior to study entry;
    3. Any other investigational medicine(s) or vaccine within 30 days prior to study entry;
    4. Blood product within 3 months prior to study entry;
    5. 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;
  • Participate or will participate in other clinical trial(s) during this study;
  • Based on the judgment of investigator(s) or the Ethic Committee, there was any condition indicating that the subject should be excluded;

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): NCT03859141


Locations
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China, Jiangsu
Guanyun Center for Disease Prevention and Control
Lianyungang, Jiangsu, China, 222200
Pizhou Center for Disease Prevention and Control
Pizhou, Jiangsu, China, 221300
Sponsors and Collaborators
Sinovac Biotech Co., Ltd
Investigators
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Principal Investigator: Yuemei Hu, Bachelor Jiangsu Provincial Center for Disease Prevention and Control
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT03859141    
Other Study ID Numbers: PRO-QINF-3002
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019

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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:
Influenza Vaccine
Quadrivalent
Trivalent
Children
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs