A long-term, open, follow-up of the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine in healthy female subjects up to 10 years after administration of the first vaccine dose in study HPV 014. - HPV-060 EXT 014 Y5-10

GlaxoSmithKline Biologicals0 sites667 target enrollmentOctober 19, 2009

Overview

Phase: Not Applicable
Intervention: Not specified
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.
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 667
Status: Active, not recruiting
Last Updated: 10 years ago

No summary available.

Registry

who.int

Start Date

October 19, 2009

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•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
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•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\.