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

NCT03859141 | Completed Phase 3

• 1 other identifier: PRO-QINF-3002
• Study Type: interventional
• Target: 2,340
• Locations: 1 country
• Sites: 2

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.

Conditions

Seasonal Influenza

Keywords

Influenza Vaccine; Quadrivalent; Trivalent; Children

Outcome Measures

Primary Outcomes (2)

• 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.

  Immunogenicity index, One of the standard to evaluate the experimental vaccine is non-inferior to the control vaccines.

  28 days after two doses immunization

• The lower limit of 95% CI of the seroconversion rate difference (experimental group-control group)≥-10%.

  Immunogenicity index, Another standard to evaluate the experimental vaccine is non-inferior to the control vaccines.

  28 days after two doses immunization

Secondary Outcomes (10)

• The lower limit of 95%CI of the ratio of GMT (experimental group/control group) >1.5.

  28 days after two doses immunization

• The lower limit of 95% CI of the difference of HI antibody seroconversion rate (experimental group-control group)>10%

  28 days after two doses immunization

• The lower limit of 95% CI of seroconversion rate for each HI antibody after two doses immunization≥40%.

  28 days after two doses immunization

• The seroprotective rate (HI antibody titer≥1:40) of each HI antibody after two doses immunization≥70%.

  28 days after two doses immunization

• The geometric mean increase (GMI) of each HI antibody after two doses immunization >2.5.

  28 days after two doses immunization

Study Arms (4)

Experimental group-phase Ⅰ

EXPERIMENTAL

Quadrivalent influenza vaccine

Biological: Quadrivalent influenza vaccine

Experimental group-phase Ⅲ

EXPERIMENTAL

Quadrivalent influenza vaccine

Biological: Quadrivalent influenza vaccine

Control group 1-phase Ⅲ

ACTIVE COMPARATOR

Trivalent influenza vaccine (contains B/Victoria strain)

Biological: Trivalent influenza vaccine (contains B/Victoria strain)

Control group 2-phase Ⅲ

ACTIVE COMPARATOR

Trivalent influenza vaccine (contains B/Yamagata strain)

Biological: Trivalent influenza vaccine (contains B/Yamagata strain)

Interventions

Quadrivalent influenza vaccine BIOLOGICAL

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

Experimental group-phase Ⅰ

Trivalent influenza vaccine (contains B/Victoria strain) BIOLOGICAL

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

Control group 1-phase Ⅲ

Trivalent influenza vaccine (contains B/Yamagata strain) BIOLOGICAL

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

Control group 2-phase Ⅲ

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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:
• Any subunit vaccine or inactivated vaccine (e.g., pneumococcal vaccine) or treatment of allergy within 14 days prior to study entry;
• Any live attenuated vaccine within 30 days prior to study entry;

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (2)

Guanyun Center for Disease Prevention and Control

Lianyungang, Jiangsu, 222200, China

Location

Pizhou Center for Disease Prevention and Control

Pizhou, Jiangsu, 221300, China

Location

Related Publications (1)

• 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.

  PMID: 32347785 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Yuemei Hu, Bachelor

  Jiangsu Provincial Center for Disease Prevention and Control

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The phase Ⅰ clinical trial was a single arm.The phase Ⅲ was 3 parallel arms.

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 1, 2019
• Study Start: February 6, 2018
• Primary Completion: April 17, 2018
• Study Completion: November 2, 2018
• Last Updated: March 1, 2019

Record last verified: 2019-02

Locations

CN (2)