Status:
COMPLETED
Swine Flu (Influenza A H1N1) Follow on Vaccine Study
Lead Sponsor:
University of Oxford
Conditions:
Influenza
Eligibility:
All Genders
17-14 years
Brief Summary
In 2009 the World Health Organization (WHO) declared the Influenza A H1N1 (swine 'flu) outbreak the first global pandemic of this century. It is thought to have been responsible for 16,226 deaths glob...
Detailed Description
In Autumn 2009 the investigators undertook a study assessing the safety and immunogenicity of a two-dose schedule of the two Influenza A (H1N1) vaccines purchased by the UK Government, the non-adjuvan...
Eligibility Criteria
Inclusion
- The participants must have completed the original NIHR funded study (NCT00980850)(1) comparing Celvapan with Pandemrix at one of the study sites participating in this follow-on study.
- A parent/legal guardian has given written informed consent after the nature of the study has been explained.
- Willingness to either
- undertake a blood test at visit 1 ('persistence' cohort)
- complete all study procedures ('booster' cohort)
Exclusion
- Participant(s) in original study (NCT00980850)(1) who had a suspected unexpected serious adverse reaction (SUSAR).
- Participants in the original study (NCT00980850)(1) who did not receive two doses of H1N1 influenza vaccine.
- Participants in original study (NCT00980850)(1) who received a third dose of H1N1 influenza vaccine due to an inadequate response to two doses.
- History of severe allergic reaction after previous vaccinations or hypersensitivity to any seasonal influenza 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 enrolment.
- Receipt of blood, blood products and/or plasma derivatives or any immunoglobulin preparation within 3 months prior to enrolment.
- Previous receipt of, or intent to immunize with, any other seasonal influenza vaccine(s) throughout the 2010/2011 influenza season.
- 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 :
November 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
560 Patients enrolled
Trial Details
Trial ID
NCT01239537
Start Date
November 1 2010
End Date
December 1 2010
Last Update
December 8 2017
Active Locations (5)
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1
Bristol Children's Vaccine Centre, University of Bristol
Bristol, United Kingdom
2
Royal Devon and Exeter NHS Foundation Trust
Exeter, United Kingdom, EX2 5DW
3
St George's Vaccine Institute, University of London
London, United Kingdom
4
Oxford Vaccine Group, University of Oxford
Oxford, United Kingdom, OX3 7LJ