Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine (15µg/0.5ml)

NCT03853993 | Completed Phase 3

• 1 other identifier: PRO-QINF-3001
• Study Type: interventional
• Target: 2,380
• 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 subjects aged over 3 years

Conditions

Seasonal Influenza

Keywords

Influenza Vaccine; Quadrivalent; Trivalent

Outcome Measures

Primary Outcomes (2)

• The lower limit of 95% confidence intervals (95%CI) of the ratio of geometric mean titer of hemagglutination inhibition (HI) antibody titer (experimental group/control group)≥2/3.

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

  28 days after the injection

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

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

  28 days after the injection

Secondary Outcomes (13)

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

  28 days after the injection

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

  28 days after the injection

• The 95% CI lower limit of seroconversion rate of HI antibodies in the subjects aged 3-59 years≥40%

  28 days after the injection

• The 95% CI lower limit of seroconversion rate of HI antibodies in the subjects aged over 60 years≥30%

  28 days after the injection

• The seroprotective rate (HI antibody titer≥1:40) in the subjects aged 3-59 years ≥70%

  28 days after the injection

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

Received single dose QIV (15µg/0.5ml)

Experimental group-phase I; Experimental group-phase III

Trivalent influenza vaccine (contains B/Victoria strain) BIOLOGICAL

Received single dose TIV which contains B/Victoria strain (15µg/0.5ml)

Control group-1-phase III

Trivalent influenza vaccine (contains B/Yamagata strain) BIOLOGICAL

Received single dose TIV which contains B/Yamagata strain (15µg/0.5ml)

Control group-2-phase III

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers aged ≥3 years;
• Proven legal identity;
• Participants or (and) guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment;

You may not qualify if:

• Prior vaccination with influenza vaccine of the current year;
• History of influenza within 6 months prior to study entry;
• Axillary temperature \> 37.0 °C;
• History of allergy to any vaccine, or any ingredient of the experimental vaccine, especially eggs, egg albumin, etc.;
• Serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc.;
• Severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness;
• Autoimmune disease or immunodeficiency/immunosuppressive, or any immunosuppressant receipt within 6 months prior to the study entry;
• History of asthma, thyroidectomy, angioedema, diabetes or malignancy;
• No spleen, or functional no spleen, or splenectomy.

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (2)

Guanyun Center for Disease Control and Prevention

Lianyungang, Jiangsu, 222200, China

Location

Pizhou Center for Disease Control and Prevention

Pizhou, Jiangsu, 221300, China

Location

Related Publications (1)

• Chu K, Xu K, Tang R, Tian X, Hu J, Yang T, Li C, Hu Y, Zeng G. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine: A randomized, double-blind, controlled phase III study in healthy population aged >/=3 years. Vaccine. 2020 Aug 18;38(37):5940-5946. doi: 10.1016/j.vaccine.2020.06.071. Epub 2020 Jul 27.

  PMID: 32732142 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 Province Center for Disease Control and Prevention

  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 has single arm, and the phase III clinical trial has 3 parallel arms.

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 26, 2019
• Study Start: January 23, 2018
• Primary Completion: August 17, 2018
• Study Completion: October 8, 2018
• Last Updated: February 27, 2019

Record last verified: 2019-02

Locations

CN (2)