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Only swine flu jab trials on children not to be completed for a year
Only swine flu jab trials on children not to be completed for a year
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Only swine flu jab trials on children not to be completed for a year
The first clinical trial on children of a vaccine against the swine flu vaccine has begun in Oxford, but the trial is not expected to be completed until September 2010.
The trial started in September and involves 1000 children between 6 months and 12 years old, who are to be given Baxter's and GlaxoSmithKline's swine flu jabs, according to a US government clinical trials database.
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GSK's Pandemrix contains the adjuvant, squalene, but Baxter appears to have dropped the adjuvant and mercury from its Celvapan after pressure from the German army, who refused to give the jab to their soldiers.
The Estimated Primary Completion Date or final data collection date for primary outcome measure is December 2009. But the results will not be available for Oxford University for another nine months or September 2010.
Also, the study will recruit only healthy children 6 months to 12 years of age.
"Children with previously laboratory confirmed infection with swine flu will be excluded, as will those that have received a treatment course of oseltamivir."
Children with immune deficiencies are to be excluded, even though large numbers of children are estimated to have immune deficiencies.
The contact person for the trial is listed as Dr Andrew Pollard, leader of the Oxford Vaccine Group and a participant in the Jenner group. Pollard has already carried out trials on the bird flu drug.
The study will be conducted as a collaboration between the Health Protection Agency and the Oxford Vaccine Group (OVG), Bristol Children's Vaccine Centre (BCVC), the Royal Devon and Exeter Hospital, St George's Vaccine Institute (SGVI) and the University of Southampton Wellcome Trust Clinical Research Facility (USWTCRF).
Among the sponsors of the Jenner group are the European Commission, the Gates Foundation, the US NIH, the Foundation for the NIH, International AIDS Vaccine Initiative, and the UK Department of Health.
Jane Burgermeister
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