Immune Response Study of Influenza Vaccine
An observational clinical study will be performed in subjects aged 12-60 years old to describe the dynamic changes of humoral immune/cellular immunity after vaccination of influenza vaccine, and to discuss the role of different antibodies against influenza virus infection, and to look for possible factors related to side effects with the vaccine.
Influenza Vaccine Allergy
Cell Mediated Reaction
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Humoral and Cellular Immune Response Study of Influenza Vaccine|
- the dynamic changes of humoral immune/cellular immunity after vaccination of influenza vaccine [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||March 2011|
|Study Completion Date:||December 2012|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
A randomized clinical trial will be conducted to describe immune response of seasonal influenza virus vaccine in a single center in China. 200 subjects aged 18-60 years will be enrolled under the premise of informed consent and receive one dose of vaccine. All vaccinations will be done by specific study personnel, who do not take part in the assessment of safety or immunogenicity. Adverse events will be recorded after vaccination and blood samples were collected at 0,7,14,28 days for antibody detection and split vaccine neutralizing antibody detection, determination of cellular immune function in the same time.
The clinical program approved by the ethics committee will be performed by the researchers independently. Inspectors designated by the sponsor will take meticulous on-site audits to ensure the safety specifications during the whole process of research.