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number of participants in trial

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Please note the number of participants quoted as taking part in this trial - which gived CSL the ability to say this vaccine is safe.

 

Has CSL published any data on Panvax® H1N1 clinical trial?

The preliminary results of a Panvax® H1N1 clinical trial were recently published in the New England Journal of Medicine (NEJM). The trial involved 240 healthy adults aged 18 to 64 years and was conducted in Australia. The trial was designed to evaluate the dose needed and the safety of the vaccine. The preliminary results show that a single 15µg dose of the H1N1 vaccine should be sufficient to provide adequate protection in adults against the H1N1 pandemic influenza. The response is similar to what would be expected with a seasonal influenza vaccine in a similar population.The results also showed that there were no safety signals and that the H1N1 vaccine has a safety and tolerability profile consistent with that seen with seasonal flu vaccines.The study is ongoing and final study results are expected later this year.Paediatric clinical trials (in children aged 6 months to 9 years) are ongoing and preliminary results are expected in mid-late October.

 

http://www.csl.com.au/s1/cs/auhq/1236380109044/content/1236380109063/content.htm

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