Study results of CSL’s pandemic H1N1 2009 vaccine published in JAMA

Dec 22 2009

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 three weeks later.

“As influenza can be a very severe disease in young children which spreads rapidly in those attending school or day care, the published results of this trial are important and timely”

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 percent of children in both age groups had protective antibody levels. Immune responses were robust regardless of age, baseline immune status, or seasonal influenza vaccine immunization 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 day care, 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 for use in infants and children.

http://www.csl.com.au/