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

NCT ID: NCT03859141

Last Updated: 2019-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2340 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-06
• Study Completion Date: 2018-11-02

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.

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.

Conditions

Seasonal Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Experimental group-phase Ⅰ

Quadrivalent influenza vaccine

Group Type: EXPERIMENTAL

Quadrivalent influenza vaccine

Intervention Type: BIOLOGICAL

One dose of quadrivalent influenza vaccine: 0.25 ml per dose containing 7.5μg antigen.

Experimental group-phase Ⅲ

Quadrivalent influenza vaccine

Group Type: EXPERIMENTAL

Quadrivalent influenza vaccine

Intervention Type: BIOLOGICAL

One dose of quadrivalent influenza vaccine: 0.25 ml per dose containing 7.5μg antigen.

Control group 1-phase Ⅲ

Trivalent influenza vaccine (contains B/Victoria strain)

Group Type: ACTIVE_COMPARATOR

Trivalent influenza vaccine (contains B/Victoria strain)

Intervention Type: BIOLOGICAL

One dose of trivalent influenza vaccine (contains B/Victoria strain): 0.25 ml per dose containing 7.5μg antigen.

Control group 2-phase Ⅲ

Trivalent influenza vaccine (contains B/Yamagata strain)

Group Type: ACTIVE_COMPARATOR

Trivalent influenza vaccine (contains B/Yamagata strain)

Intervention Type: BIOLOGICAL

One dose of trivalent influenza vaccine (contains B/Yamagata strain): 0.25 ml per dose containing 7.5μg antigen.

Interventions

Quadrivalent influenza vaccine

One dose of quadrivalent influenza vaccine: 0.25 ml per dose containing 7.5μg antigen.

Intervention Type: BIOLOGICAL

Quadrivalent influenza vaccine

One dose of quadrivalent influenza vaccine: 0.25 ml per dose containing 7.5μg antigen.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Eligibility 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;

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 35 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sinovac Biotech Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuemei Hu, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Provincial Center for Disease Prevention and Control

Locations

Guanyun Center for Disease Prevention and Control

Lianyungang, Jiangsu, China

Pizhou Center for Disease Prevention and Control

Pizhou, Jiangsu, China

Countries

China

References

Hu Y, Shao M, Hu Y, Liang Q, Jia N, Chu K, Xu L, Li J, Li C, Zhu F. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine: a randomized, double-blind, controlled phase III clinical trial in children aged 6-35 months in China. Hum Vaccin Immunother. 2020 Jul 2;16(7):1691-1698. doi: 10.1080/21645515.2020.1721994. Epub 2020 Apr 29.

Reference Type: DERIVED

PMID: 32347785 (View on PubMed)

Other Identifiers

PRO-QINF-3002

Identifier Type: -

Identifier Source: org_study_id