Follow-up study to evaluate the long-term immunogenicity and safety ofGlaxoSmithKline Biologicals' HPV (580299) vaccine in healthy femalesubjects.

Conditions: For active immunization of women from the age of 10 years onwards to prevent cervical cancer (squamous-cell carcinoma and adenocarcinoma) by protecting against incident and persistent infections, cytological abnormalities including atypical squamous cells of undetermined significance (ASC US) and cervical intraepithelial neoplasia (CIN), CIN1 and pre-cancerous lesions (CIN2 and CIN3), caused by oncogenic human papillomavirus (HPV) types 16 and 18.
MedDRA version: 15.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2009-011357-41-DE

Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 667

Inclusion Criteria

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
• A female who enrolled in study HPV-014 and received three doses of HPV-16/18 vaccine.
• Written informed consent obtained from the subject.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 647
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

• Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period.
• Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling. For corticosteroids, this will mean prednisone, >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
• Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
• Administration or planned administration of any HPV vaccine, other than the three doses of HPV-16/18 vaccine administered in study HPV 014.