GlaxoSmithKline says data supports Cervarix two-dose schedule for young girls

GlaxoSmithKline announced the results of a Phase III study of its HPV vaccine, Cervarix, which showed that two doses of the vaccine in girls aged 9 to 14 years provide an immunogenicity matching the currently licensed three-dose schedule in 15 to 25 year olds.In the trial, HPV-070, 1,447 patients across five countries were randomized to receive Cervarix. The results showed that the two-dose schedule in girls aged 9 to 14 years old induced immune responses which were comparable to that seen with the 3 dose schedule in 15 to 25 year olds suggesting quality and quantity of the immune response are comparable to the three-dose schedule. The results corroborate the findings of an earlier proof of concept study, HPV-048, which also assessed the immunogenicity of two doses of Cervarix compared to its three-dose schedule and demonstrated that the immunogenicity of two doses of Cervarix in 9 to 14 year old girls is comparable to that seen with three doses in 15 to 25 year olds girls for both the vaccine HPV types 16 & 18 and for non-vaccine types 31 & 45, throughout the four year study period.

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