Infections, Papillomavirus Clinical Trial
Official title:
A Phase III, Double-blind, Randomized, Controlled Study to Evaluate Immunogenicity and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine, Administered Intramuscularly (0, 1, 6 Month Schedule) in Healthy Females Aged 18 - 35 Years
Human papillomavirus infection has clearly been recognized as the cause of cervical cancer.
Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can
lead over time to cervical cancer in women . This study will evaluate the immune response
induced by the HPV-16/18 L1 VLP AS04 vaccine and the safety of the vaccine.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
2007.
The protocol was primarily amended for the following reason:
Merck's tetravalent HPV vaccine, Gardasil®, has been licensed and is now becoming
commercially available in an increasing number of countries. Therefore, the study procedures
were revised to include questions at every visit to determine if subjects have received an
HPV vaccine outside of the study.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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