Evaluation of the Effectiveness of Two Vaccination Strategies Using GlaxoSmithKline Biologicals' HPV Vaccine GSK580299 (Cervarix TM) Administered in Healthy Adolescents
As GSK Biologicals' HPV vaccine GSK580299 is not licensed for use in boys, the boys included
in the current study and receiving the HPV vaccine are considered to be part of a Phase 3
trial. The study is partially blinded as some study participants will be aware of their
group allocation but blinded to their treatment allocation. Overall, the study will be open.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
HPV-16 and/or HPV-18 DNA positivity in all 18 - 19 year old female study participants
At the time of analysis
No
GSK Clinical Trials
Study Director
GlaxoSmithKline
Finland: Finnish Medicines Agency
106636
NCT00534638
October 2007
June 2014
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