CSL Reports Results For Swine Flu Vaccine Trial In Children

Published: 22-Dec-2009

Australian trial showed that a single dose produces excellent immune response

Australia-based CSL has announced that the Journal of the American Medical Association (JAMA) has published data from a clinical trial conducted in Australia to study H1N1 2009 'swine' flu vaccine. Results of the trial demonstrated a robust immune response after a single dose in children as young as six months, which is further enhanced by the administration of a second dose given three 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 15mcg or a 30mcg dose of the vaccine. A second dose was given to each group three weeks later.

Analysis of the data showed that following the initial dose, 15mcg induces protective antibody levels in 92% of children aged 6 to 35 months and 92.9% 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, said the company.

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