FDA Approves GlaxoSmithKline Combination Vaccine
By Alice Turner
22:25, June 25th 2008
39 votes
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FDA Approves GlaxoSmithKline Combination Vaccine

The Food and Drug Administration has approved a four-in-one vaccine by GlaxoSmithKline. The combination vaccine is for protecting 4 to 6 year old children against diphtheria, tetanus, pertussis and polio diseases in one shot. KINRIX will actually a booster vaccine for use in those children who already received GSK's Infanrix or Pediarix combination vaccines.

The decision was taken after a Phase III trial of KINRIX which comprised a randomized controlled study involving 3,156 US children aged from 4 to 6 years who were vaccinated with KINRIX at the same time as receiving their second dose of measles, mumps and rubella (MMR) vaccine (US licensed M-M-RII).

The approval follows that of rival French drugmaker Sanofi-Aventis SA, which was granted a license for a 5-in-1 vaccine for use with children under 5 to protect them against diptheria, tetanus, pertussis, polio and Hib disease.

Combination vaccines allow for fewer trips to the doctor for children and their parents.

Last month, GlaxoSmithKline, the United Kingdom-based pharmaceutical, biological, and healthcare company, announced it had received the go-ahead to sell its bird-flu vaccine in the 27 member countries of the European Union as well. The permission was a historic milestone for the drug maker. GSK is the first company which was granted permission to sell its vaccine (Prepandrix) in the EU.



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