Status:
COMPLETED
Swine Flu (Novel Influenza A H1N1) Vaccine Study
Lead Sponsor:
University of Oxford
Conditions:
Influenza
Eligibility:
All Genders
6-12 years
Phase:
PHASE2
Brief Summary
In the first half of this year a novel Influenza A H1N1 virus has resulted in an influenza pandemic. The United Kingdom has seen a particularly high incidence of disease. The highest rates of disease ...
Detailed Description
The study will be an open label, randomised, parallel group, multicentre clinical trial conducted by a consortium of the leading paediatric vaccine research units in the United Kingdom. The study will...
Eligibility Criteria
Inclusion
- baby or child aged between 6 months to 12 years of age (i.e., to day before 13th birthday)
- for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained
- available for all the visits scheduled in the study
- willingness to complete all study procedures
Exclusion
- History of any vaccine against novel influenza A strain H1N1 (based on verbal confirmation from parent/guardian)
- Previous laboratory confirmed case of novel influenza A strain H1N1 or treatment with oseltamivir or zanamivir for novel influenza A strain H1N1 (n.b. a child commenced on treatment with oseltamivir or zanamivir for novel influenza A strain H1N1 whose treatment was stopped following negative microbiological tests for H1N1 on nasal swabs would be allowed to enrol in the study\]
- History of severe allergic reaction after previous vaccinations or hypersensitivity to any H1N1 vaccine component
- Current egg allergy
- Known or suspected impairment/alteration of the immune system
- Disorders of coagulation
- Immunosuppressive therapy, use of systemic corticosteroids for more than 1 week within the 3 months prior to enrollment
- Receipt of blood, blood products and/or plasma derivatives or any immunoglobulin preparation within 3 months prior to enrollment
- Intent to immunize with any other vaccine(s) against novel influenza A strain H1N1 throughout the study period
- Participation in another clinical trial of an investigational medical product
- Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. Children with chronic, stable medical illnesses that do not result in immunosuppression (e.g., cerebral palsy, epilepsy, cystic fibrosis, congenital heart disease) will be allowed to participate in the study, unless these conditions will in some way interfere with the completion of study procedures. Children with conditions that may alter the immune response to vaccines (e.g., Trisomy 21) or will affect the ability to accurately describe adverse events (e.g., children over 5 years of age but with severe learning difficulties) will be excluded
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00980850
Start Date
September 1 2009
End Date
December 1 2009
Last Update
May 9 2013
Active Locations (5)
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1
Bristol Children's Vaccine Centre
Bristol, Bristol, United Kingdom, BS2 8AE
2
St Georges Vaccine Institute
London, London, United Kingdom, SW17 ORE
3
Royal Devon and Exeter NHS Foundation Trust
Exeter, United Kingdom, EX2 5DW
4
Oxford Vaccine Group
Oxford, United Kingdom, OX3 7LJ