Study to Evaluate the Efficacy of the Human Papillomavirus Vaccine in Healthy Adult Women of 26 Years of Age and Older.

This study will evaluate the immune responses, safety and efficacy of the investigational HPV vaccine in women who are 26 years of age or older. Infection with human papilloma virus (HPV) has been clearly established as the central cause of cervical cancer.

Official Title

A Study to Evaluate the Safety, Immunogenicity & Efficacy of GSK Biologicals HPV-16/18 L1/AS04 Vaccine Administered Intramuscularly According to a Three-Dose Schedule (0, 1, 6 Month) in Healthy Adult Female Subjects Aged 26 Years and Above

Conditions

Prophylaxis for HPV Infections & Associated Cervical Neoplasia

Study Type

Interventional

Study Design

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further Details

• Primary Outcome Measures: Demonstration of vaccine efficacy in the prevention of infection with HPV-16 or HPV-18.
• Secondary Outcome Measures: Demonstration of vaccine efficacy against:infection with other oncogenic HPVs, CIN associated with HPV-16/18 & cytological abnormality associated with HPV-16/18 or other oncogenic HPVs; Evaluation of vaccine immunogenicity and safety.
• Study participation lasts approximately 36 months and involves a total of nine scheduled visits.

Study Start

February 2006

Eligibility & Criteria

• Ages Eligible for Study: 26 Years and above
• Genders Eligible for Study: Female

Inclusion Criteria

• Women of at least 26 years of age at the time of the first vaccination
• Subject must have a negative urine pregnancy test
• Healthy subject before entering the study as established by medical history and physical/gynaecological examination.
• Subject must be of non-childbearing potential
• Written informed consent obtained from the subject prior to enrolment.

Exclusion Criteria

• Pregnant or breastfeeding
• Previous vaccination against HPV or administration of AS04 (contained in Fendrix®).
• Known acute or chronic clinically significant neurologic, hepatic or renal functional abnormality.
• History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes or autoimmune disease

Total Enrolment

Contact Details

GlaxoSmithKline, Melbourne, Australia