Immunogenicity and Safety of a Quadrivalent Influenza Vaccine in Participants Aged Above 3 Years
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- Shanghai Institute Of Biological Products
- Enrollment
- 2688
- Locations
- 2
- Primary Endpoint
- Number of participants that presented seroconversion post injection
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
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
- 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)