Immune Response Study of Influenza Vaccine
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|ClinicalTrials.gov Identifier: NCT01310374|
Recruitment Status : Completed
First Posted : March 8, 2011
Last Update Posted : July 10, 2013
|Condition or disease|
|Influenza Vaccine Allergy Cell Mediated Reaction|
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.
|Study Type :||Observational|
|Actual Enrollment :||207 participants|
|Official Title:||Humoral and Cellular Immune Response Study of Influenza Vaccine|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||December 2012|
- the dynamic changes of humoral immune/cellular immunity after vaccination of influenza vaccine [ Time Frame: one year ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01310374
|Principal Investigator:||jiang wu, Bachelor||Beijing Centers for Disease Control and Prevention|