Influenza
Conditions
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.
Interventions
BIOLOGICALQuadrivalent influenza vaccine
0.5 mL, intramuscular, one dose
BIOLOGICALTrivalent influenza vaccine A
0.5 mL, intramuscular, one dose
BIOLOGICALTrivalent influenza vaccine B
0.5 mL, intramuscular, one dose
Sponsors
Shanghai Institute Of Biological Products
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants that presented seroconversion post injection | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of participants that presented seroprotection post injection | 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 |
| Number of Subjects Reporting Solicited and Unsolicited Adverse Events (AEs) | 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 |
Countries
China
Outcome results
None listed