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Completed

NCT Number: NCT03744104

A Clinical Trial of A Quadrivalent Influenza Vaccine

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Suining County Center for Disease Control and Prevention, Xuzhou, Jiangsu, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quadrivalent Influenza Vaccine

Biological

0.5 mL, intramuscular, one dose

Trivalent influenza vaccine A

Biological

0.5 mL, intramuscular, one dose

Trivalent influenza vaccine B

Biological

0.5 mL, intramuscular, one dose

Primary outcomes

  1. Number of participants that presented seroconversion post injection

    Time frame: 30 days after inoculation

    • 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

  2. Geometric mean of Hemagglutination-inhibition titre post first study injection

    Time frame: 30 days after inoculation

    • 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.

Secondary outcomes

  1. Number of participants that presented seroprotection post injection

    Time frame: 30 days after inoculation

    • 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

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

    Time frame: Continuous observation for 30 days after two inoculations

    • 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

Sponsors and collaborators

Lead sponsor

Shanghai Institute Of Biological Products

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 16, 2018
Registry last updated
Jan 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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