Influenza Vaccine Allergy Clinical Trial
Official title:
Humoral and Cellular 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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06446232 -
Influenza Vaccine Effectiveness in Among Young Children in Taiwan
|
||
| Completed |
NCT03654937 -
Immune Response and Risk of Side Effects After Influenza Vaccination in Athletes
|
Phase 4 |