Status:
COMPLETED
A Post-marketing Safety Study of Beijing Tiantan Biological's Influenza Virus Vaccine in Elderly
Lead Sponsor:
Centers for Disease Control and Prevention, China
Collaborating Sponsors:
Beijing Tiantan Biological Products Co., Ltd.
Conditions:
Influenza
Vaccination Adverse Event
Eligibility:
All Genders
60+ years
Brief Summary
To monitor the safety of Beijing Tiantan Biological's influenza vaccine in elderly through Adverse Events Following Immunization Surveillance System of China. The hypothesis is that there is no signi...
Detailed Description
In 2011 and 2012, Beijing Municipal Health Bureau launched the free influenza vaccination campaign among children aged 6-18 years old and the elderly aged 60 years old and above. Inactivated split-vir...
Eligibility Criteria
Inclusion
- Males and females aged 60 years and above on the day of immunization, who are eligible for seasonal influenza vaccination.
- In the judgement of the study doctor are determined to be in reasonable health considering their age and able to comply with all study procedure.
Exclusion
- History of any serious reaction to flu vaccine, or any materials in the vaccine, and to eggs (including ovalbumin) and chicken protein.
- Receipt of a live vaccine within 4 weeks prior to Study Day 1.
- Any condition, which in the opinion of the study doctor, might interfere with the evaluation of the study objective.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
536812 Patients enrolled
Trial Details
Trial ID
NCT01906593
Start Date
June 1 2013
End Date
July 1 2013
Last Update
July 24 2013
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