NCT00481767 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Kiviat N et al
Immunisation of African pre-teen/adolescent girls and young women with the HPV-16/18 AS04-adjuvanted vaccine. Abstract presented at South African Society of Obstetricians and Gynaecologists - O & G Update 2011. Pretoria, South Africa, 5-7 May 2011.
Sow PS, Watson-Jones D, Kiviat N, Changalucha J, Mbaye KD, Brown J, Bousso K, Kavishe B, Andreasen A, Toure M, Kapiga S, Mayaud P, Hayes R, Lebacq M, Herazeh M, Thomas F, Descamps D
Safety and immunogenicity of human papillomavirus-16/18 AS04-adjuvanted vaccine: a randomized trial in 10-25-year-old HIV-Seronegative African girls and young women. J Infect Dis. 2013 Jun 1;207(11):1753-63. doi: 10.1093/infdis/jis619. Epub 2012 Dec 13.
Sow PS
et al. Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in African preteen/adolescent girls and young women. Abstract presented at the African Organisation for Research and Training in Cancer (AORTIC). Cairo, Egypt, November 30 - December 3, 2011.
Watson-Jones D, Baisley K, Brown J, Kavishe B, Andreasen A, Changalucha J, Mayaud P, Kapiga S, Gumodoka B, Hayes RJ, de Sanjosé S
High prevalence and incidence of human papillomavirus in a cohort of healthy young African female subjects. Sex Transm Infect. 2013 Aug;89(5):358-65. doi: 10.1136/sextrans-2012-050685. Epub 2013 Mar 13.

Study to Assess the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' HPV Vaccine GSK580299 in Healthy Female Subjects Aged 10-25 Years.

Details for clinical trial NCT00481767

Clinical trial NCT00481767 - References