Status:
COMPLETED
Post-Authorization Safety Study of GSK Biologicals' Pandemic Influenza Vaccine (H1N1) in the United Kingdom
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
Brief Summary
The focus of this study is to assess the safety of GSK's H1N1 vaccine in real life conditions as soon as the vaccine is used, in a mass vaccination programme, and with a system for rapid generation, c...
Detailed Description
Collaborator: Medicines and Healthcare products Regulatory Agency
Eligibility Criteria
Inclusion
- Written informed consent, and assent where appropriate, obtained from the subject/from the subject's parent(s)/ Legally Acceptable Representative(s) (LAR).
- A male or female subject vaccinated with a first dose of GSK Biologicals' H1N1 pandemic influenza vaccine
- shortly (\<24h) before being recruited in the study, and
- within a GP practice participating in the study and where the subject is registered.
- Subjects who the Investigator believes that they and/or their parent(s)/LAR can and will comply with the requirements of the protocol
Exclusion
- Subjects already vaccinated with any other H1N1 pandemic vaccine before study enrolment.
- Child in care
Key Trial Info
Start Date :
October 31 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 6 2011
Estimated Enrollment :
9206 Patients enrolled
Trial Details
Trial ID
NCT00996853
Start Date
October 31 2009
End Date
April 6 2011
Last Update
January 16 2018
Active Locations (91)
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1
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB3 9HS
2
GSK Investigational Site
Watford, Hertfordshire, United Kingdom, WD25 0EA
3
GSK Investigational Site
Canterbury, Kent, United Kingdom, CT1 3HX
4
GSK Investigational Site
Blackburn, Lancashire, United Kingdom, BB2 2ST