A Phase 3 interventional study of HPV-16/18 L1/AS04 in Infections, Papillomavirus, sponsored by GlaxoSmithKline. Completed at 61 sites in 12 countries. Open to female participants aged 10 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-23.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention
Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the safety and immunogenicity of GSK Biologicals HPV-16/18 vaccine over 12 months, in pre-teen and adolescent women of 10-14 years of age at study start. Approximately 2000 study subjects will receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule.
GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
A woman between, and including, 10 and 14 years of age at the time of the first vaccination.
Written informed consent from the subject prior to enrolment. Subject must be free of obvious health problems. Subject must have negative urine pregnancy test.
Exclusion Criteria:
Pregnant or breastfeeding. Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality.
History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, or autoimmune disease.
Previous vaccination against human papillomavirus (HPV).
Demonstration of safety of the HPV vaccine compared to the control (occurrence of SAEs) up to month 7.
Safety of HPV vaccine in entire study period. Vaccine immunogenicity.
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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