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GSK announces data to support Cervarix® two-dose schedule for the prevention of cervical cancer in 9-14 year old girls

GSK today announced the results of a Phase III study of its HPV vaccine, Cervarix.

Issued: London UK

GlaxoSmithKline (GSK) plc today announced the results of a Phase III study of its HPV vaccine, Cervarix [Human papillomavirus (types 16 and 18) vaccine, recombinant], 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 (aged 9 to 25 years) across five countries were randomised to receive Cervarix. A group of girls aged 9 to 14 years received the vaccine in a two-dose schedule which was compared to another group of 15 to 25 year olds who received it as a three-dose schedule.

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.

These findings consistently suggest that the immune response of the two-dose schedule in girls aged 9 to 14 years with Cervarix is in line with the three-dose schedule. Similarly, the safety profile is similar when compared to the three-dose group.

The results will be presented at today at the EUROGIN conference in Florence.

The vaccine is currently only approved in the EU for use in females from the age of nine years, administered according to a three-dose schedule (vaccination at months 0, one and six) for the prevention of premalignant genital (cervical, vulvar and vaginal) lesions and cervical cancer causally related to certain oncogenic Human Papillomavirus (HPV) types.

A variation to the current Marketing Authorisation was submitted to the European Medicines Agency on August 7 2013 to add administration of the vaccine according to a two-dose schedule (0, 6 months) in girls aged 9 to 14 years old for the prevention of premalignant genital (cervical, vulvar and vaginal) lesions and cervical cancer causally related to certain oncogenic Human Papillomavirus (HPV) types.

The use of Cervarix in a two-dose schedule vaccination at months 0 and six in girls aged 9 to 14 years old is approved in nine countries (including Guatemala, Honduras, El Salvador, Haiti, Suriname, Chile, Guyana, Nigeria & Ghana).

Cervarix in a three-dose schedule is also approved in the US. For the full US Prescribing Information and EU Patient Information Leaflet, which includes information on the approved use of Cervarix, please visit http://www.gsk.com/en-gb/products/our-prescription-medicines-and-vaccines/.

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com.

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Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2012.