A Clinical Trial of A Quadrivalent Influenza Vaccine

NCT03744104 | Completed Phase 3

• 1 other identifier: JSVCT060
• Study Type: interventional
• Target: 2,688
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Number of participants that presented seroprotection post injection

  30 days after inoculation

• Number of Subjects Reporting Solicited and Unsolicited Adverse Events (AEs)

  Continuous observation for 30 days after two inoculations

Study Arms (3)

Quadrivalent influenza vaccine

EXPERIMENTAL

Quadrivalent influenza vaccine(containing 2 subtypes of B lineage)

Biological: Quadrivalent influenza vaccine

Trivalent influenza vaccine A

ACTIVE COMPARATOR

Trivalent influenza vaccine (containing B/Victoria lineage)

Biological: Trivalent influenza vaccine A

Trivalent influenza vaccine B

ACTIVE COMPARATOR

Trivalent influenza vaccine (containing B/Yamagata lineage)

Biological: Trivalent influenza vaccine B

Interventions

Quadrivalent influenza vaccine BIOLOGICAL

0.5 mL, intramuscular, one dose

Quadrivalent influenza vaccine

Trivalent influenza vaccine A BIOLOGICAL

0.5 mL, intramuscular, one dose

Trivalent influenza vaccine A

Trivalent influenza vaccine B BIOLOGICAL

0.5 mL, intramuscular, one dose

Trivalent influenza vaccine B

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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Institute Of Biological Products: lead

Study Sites (2)

Suining County Center for Disease Control and Prevention

Xuzhou, Jiangsu, China

Location

Xinyi County Center for Disease Control and Prevention

Xuzhou, Jiangsu, China

Location

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

• Hu Yuemei, PhD

  Jiangsu Province Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 16, 2018
• Study Start: October 11, 2018
• Primary Completion: October 8, 2019
• Study Completion: October 8, 2019
• Last Updated: January 2, 2024

Record last verified: 2023-12

Locations

CN (2)