Status:
COMPLETED
Observational Study to Assess Safety of H1N1 Pandemic Influenza Vaccine
Lead Sponsor:
Alachua Government Services, Inc.
Conditions:
Influenza
Pandemic Influenza
Eligibility:
All Genders
2+ years
Brief Summary
The purpose of this observational study, which will be initiated as soon as the licensed H1N1 Pandemic Influenza Vaccine is used in a mass vaccination campaign, is to estimate the incidence of any med...
Eligibility Criteria
Inclusion
- Male and female subjects, per indication on license or per official vaccine recommendations, will be eligible for participation in this study if:
- They will be administered CELVAPAN (= Baxter´s H1N1 pandemic influenza vaccine)
- They are 2 months of age or older at the time of first vaccine administration
- Their medical history is available
- The investigator believes they will comply with the foreseen vaccination schedule and will reliably observe signs or symptoms of adverse events during the observational period
- They and/or their parent(s)/legal guardian(s) provide written informed consent, and assent where appropriate, prior to study entry according to national law
Exclusion
- Male and female subjects will be excluded from participation in this study if:
- They have already been administered another H1N1 pandemic vaccine
- They have any contraindication to vaccination (as per the Summary of Product Characteristics and/or relevant national immunization guidelines)
Key Trial Info
Start Date :
November 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
3216 Patients enrolled
Trial Details
Trial ID
NCT00950456
Start Date
November 1 2009
End Date
February 1 2011
Last Update
October 9 2015
Active Locations (17)
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1
General Practice
Bludenz, Austria, 6700
2
General Practice
Fulpmes, Austria, 6166
3
General Practice
Hall in Tirol, Austria, 6060
4
General Practice
Innsbruck, Austria, 6020