- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01310374
Immune Response Study of Influenza Vaccine
Humoral and Cellular Immune Response Study of Influenza Vaccine
Study Overview
Status
Conditions
Detailed Description
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- aged 12-60 years old
- male or non-pregnant female
- volunteers
- clinically healthy as determined by: medical history inquiring and physical examination
- provide written informed consents before joining the trial
Exclusion Criteria:
- infected with Influenza A virus subtype H1N1(2009),
- vaccinated with seasonal influenza vaccine,
- allergic to any ingredient of vaccine,
- autoimmune disease or immunodeficiency,
- active malignancy,
- bleeding disorder,
- seizure disorder,
- Guillain-Barre Syndrome,
- treatment with cytotoxic or immunosuppressive drugs within the past 6 months,
- receipt of blood products within the past 3 months,
- administration of any other investigational research agents or live attenuated vaccine within 30 days,
- administration of subunit or inactivated vaccines within 14 days,
- axillary temperature over 37.0℃ at the time of vaccination.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the dynamic changes of humoral immune/cellular immunity after vaccination of influenza vaccine
Time Frame: one year
|
one year
|
Collaborators and Investigators
Investigators
- Principal Investigator: jiang wu, Bachelor, Beijing Centers for Disease Control and Prevention
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BJCDCWJ201101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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