A Clinical Trial of A Quadrivalent Influenza Vaccine

Immunogenicity and Safety of a Quadrivalent Influenza Vaccine in Participants Aged Above 3 Years

The aim of this study is to assess the immunogenicity and safety of a quadrivalent influenza vaccine compared with a trivalent influenza vaccine in participants aged above 3 years.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Quadrivalent influenza vaccine; Biological: Trivalent influenza vaccine A; Biological: Trivalent influenza vaccine B

• Study Type: Interventional
• Enrollment (Actual): 2688
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Chen Dandan, MS; Phone Number: 86-021-62750096-4210; Email: ddchen.sh@sinopharm.com

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China
      • Suining County Center for Disease Control and Prevention
      • Contact: Zhou fang, BS
    • Xuzhou, Jiangsu, China
      • Xinyi County Center for Disease Control and Prevention
      • Contact: Sun Weiguang, BS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Over the age of three years,healthy population
• Subjects/ (and the guardian) informed consent, voluntarily participated and signed the informed consent form, with the ability to use thermometers, scales and to fill in diary cards as required
• To comply with the requirements of clinical trial program
• Temperature≤37.0℃ on day of enrollment

Exclusion Criteria:

• A history of influenza virus infection or suspected infection Abnormal blood routine, blood biochemistry and urine routine examination indexes in last three months
• Any prior administration of influenza vaccine in last six months
• Allergy to any component in the vaccine, especially for egg allergy
• Allergy history of any previous vaccination or drug
• Acute episodes of chronic illness or acute illness on the day of vaccination
• Received a live vaccine within fourteen days prior to receiving the vaccine, or received a subunit or inactivated vaccine within seven days
• Congenital or acquired immune deficiencies, or treatment with immunosuppressive agents, such as long-term treatment with systemic corticosteroids
• Suffering from severe chronic diseases (such as Down's syndrome, diabetes, sicklemia or neurological disorders, Green's Barre syndrome)
• Asthma, required urgent treatment in last two years
• The blood products were received prior to the acceptance of the vaccine
• Known or suspected of respiratory disease, acute infection or chronic disease active period, HIV infection, cardiovascular disease, severe hypertension, malignant tumor during treatment, skin diseases
• History of epilepsy, convulsions, or a family history of psychosis
• Abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities), or obvious bruising or coagulopathy
• Plan to move or leave the area for an extended period of time before the end of the study
• Under anti-tb treatment
• Any prior administration of other research medicine/vaccine in last one month
• Women are pregnant or in the near future planned pregnancy or pregnancy test positive

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quadrivalent influenza vaccine; Quadrivalent influenza vaccine(containing 2 subtypes of B lineage)	Biological: Quadrivalent influenza vaccine; 0.5 mL, intramuscular, one dose
Active Comparator: Trivalent influenza vaccine A; Trivalent influenza vaccine (containing B/Victoria lineage)	Biological: Trivalent influenza vaccine A; 0.5 mL, intramuscular, one dose
Active Comparator: Trivalent influenza vaccine B; Trivalent influenza vaccine (containing B/Yamagata lineage)	Biological: Trivalent influenza vaccine B; 0.5 mL, intramuscular, one dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants that presented seroconversion post injection	Seroconvertion is defined as: prevaccination Hemagglutination-inhibition test (HI) antibody titer ≤1:10 and postvaccination HI antibody titer ≥1:40, or prevaccination HI antibody titer ≥1:10 and a postvaccination increase by a factor of four or more.; Participants will be collected blood post first study injection, when blood samples will be taken for HI testing	30 days after inoculation
Geometric mean of Hemagglutination-inhibition titre post first study injection	Geometric mean of Hemagglutination-inhibition test titre will be calculated for the different groups of participants post first study injection.; Participants will be collected blood post first study injection, when blood samples will be taken for HI testing.	30 days after inoculation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Reporting Solicited and Unsolicited Adverse Events (AEs)	For each group the incidence rate of subjects with solicited AE(s) with 95% confidence interval; For each group the incidence rate of subjects with unsolicited AE(s) with 95% confidence interval	Continuous observation for 30 days after two inoculations
Number of participants that presented seroprotection post injection	Seroprotection is defined as postvaccination Hemagglutination-inhibition test (HI) antibody titer ≥ 1:40.; Participants will be collected blood post first study injection, when blood samples will be taken for HI testing	30 days after inoculation

Collaborators and Investigators

• Sponsor: Shanghai Institute Of Biological Products
• Investigators: Principal Investigator: Hu Yuemei, PhD, Jiangsu Province Centers for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2018
• Primary Completion (Actual): October 8, 2019
• Study Completion (Actual): October 8, 2019

Study Registration Dates

• First Submitted: November 14, 2018
• First Submitted That Met QC Criteria: November 15, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: JSVCT060

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No