Clinical trial NCT03744104: A Clinical Trial of A Quadrivalent Influenza Vaccine
Official title: Immunogenicity and Safety of a Quadrivalent Influenza Vaccine in Participants Aged Above 3 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Lead sponsor: Shanghai Institute Of Biological Products
Sponsor class: INDUSTRY
First posted: 2018-11-16
Enrollment: 2688
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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
* 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

Primary outcomes:
measure: Number of participants that presented seroconversion post injection
timeFrame: 30 days after inoculation
measure: Geometric mean of Hemagglutination-inhibition titre post first study injection
timeFrame: 30 days after inoculation
Secondary outcomes:
measure: Number of participants that presented seroprotection post injection
timeFrame: 30 days after inoculation
measure: Number of Subjects Reporting Solicited and Unsolicited Adverse Events (AEs)
timeFrame: Continuous observation for 30 days after two inoculations
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Suining County Center for Disease Control and Prevention
state: Jiangsu
city: Xuzhou
country: China
facility: Xinyi County Center for Disease Control and Prevention
state: Jiangsu
Study officials:
affiliation: Jiangsu Province Centers for Disease Control and Prevention
name: Hu Yuemei, PhD
role: PRINCIPAL_INVESTIGATOR
References: