Findings Of Australian Trial Of Csl's H1n1 'swine' Flu Vaccine

Findings Of Australian Trial Of CSL's Pandemic (H1N1) 2009 'Swine' Flu Vaccine In Children Published In Journal Of The American Medical Association (JAMA)

22 December 2009

Results show a single dose produces excellent immune response to the vaccine

CSL Limited, Australia's leading biopharmaceutical company, announced the Journal of the American Medical Association (JAMA) has published data from a clinical trial conducted in Australia to study CSL's pandemic H1N1 2009 `swine' flu vaccine. Results of the trial demonstrate a robust immune response after a single dose in children as young as 6 months of age, which is further enhanced by the administration of a second dose given 3 weeks later.

The clinical study included 370 healthy infants and children aged 6 months to 9 years located in Perth, Adelaide, Melbourne, Sydney and Brisbane. Participants were divided into two groups, and given either a 15 mcg or a 30 mcg dose of the vaccine. A second dose was given to each group three weeks later. Blood samples to test protective antibody levels were taken at baseline, and following each dose.

Analysis of the data shows that following the initial dose, 15 mcg induces protective antibody levels in 92 percent of children aged 6 to 35 months; and 92.9 percent in children aged 3 to 9 years. After a second dose, 100% of children in both age groups had protective antibody levels. Immune responses were robust regardless of age, baseline immune status, or seasonal influenza vaccine immunisation status. The vaccine was well-tolerated, demonstrating a safety profile within the spectrum of experience with seasonal influenza vaccines in children. No safety signals were noted in the study.

'As influenza can be a very severe disease in young children which spreads rapidly in those attending school or daycare, the published results of this trial are important and timely,' lead investigator Professor Terry Nolan of the Murdoch Childrens Research Institute and University of Melbourne said today.

'Vaccinating children is a significant component of reducing influenza transmission in the community1. We are continuing to see outbreaks of H1N1 influenza in the Northern Hemisphere. Therefore, we cannot assume the threat of the disease has passed in Australia.'

'This influenza vaccine has shown an excellent level of protection against influenza in children following a single dose, however health authorities around the world have recommended two doses to provide optimum protection against this unpredictable infection,' he said.

CSL's Pandemic (H1N1) 2009 vaccine is manufactured without adjuvants, and using an identical manufacturing process to the CSL seasonal influenza vaccines. The Therapeutic Goods Administration (TGA) and the Food and Drug Administration (FDA) in the United States have fully assessed the vaccine and registered it as for use in infants and children.

For more information about CSL Limited, visit www.csl.com.au

The article can be accessed at http://jama.ama-assn.org/

Media Contact

Dr Rachel David, Director of Public Affairs, CSL Limited Phone: +61 401 775 779 Email: [email protected]

Daniella Goldberg, Ogilvy PR Health Phone: +61 416 211 067 Email: [email protected]

Rebecca Scott, Media Officer, University of Melbourne Phone: +61 417 164 791, Email: [email protected]

Professor Terry Nolan can be available for live TV interviews today via the University's DVN line.

1 Reichert T. The Japanese experience of vaccinating children against influenza. N Engl J Med, Vol. 344, No. 12. March, 2001 Monto, AS. Modification of an outbreak of influenza in Michigan by Vaccination of School children. J Infectious Diseases. Vol 122. No 1&2. July 1970

SOURCE: CSL, Murdoch Children's Research Institute, University of Melbourne