Status:
COMPLETED
Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen
Lead Sponsor:
University of Bergen
Collaborating Sponsors:
Haukeland University Hospital
Conditions:
Healthy
Eligibility:
All Genders
19-70 years
Phase:
NA
Brief Summary
Haukeland University Hospital has approximately 8000 employees many of whom will be in the front line to receive the pandemic A/H1N1 vaccine. We propose to conduct a safety and immunogenicity study in...
Detailed Description
The investigators will conduct a safety and immunogenicity study in health employees as detailed below: * Examine adverse events of all employees after vaccination using adverse events form * Examine...
Eligibility Criteria
Inclusion
- Signed informed consent Subjects able to understand and comply with the study protocol and complete the Adverse Event Form Subjects able to attend the scheduled visits for the kinetic study
Exclusion
- Persons with a history of anaphylaxis or serious reactions to any vaccine
- Person with known hypersensitivity to any of the vaccine components
- Persons who have had a temperature \>38oC during the previous 72 hours
- Persons who have had an acute respiratory infection during the last 7 days
- Suspected non-compliance
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT01003288
Start Date
October 1 2009
End Date
December 1 2014
Last Update
November 18 2019
Active Locations (1)
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1
Haukeland University Hospital
Bergen, Norway, N5021