A long-term, open follow-up of the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 VLP/AS04 vaccine in healthy female subjects up to 10 years after administration of the first vaccine dose in study HPV-013. - HPV-025 EXT 013

GlaxoSmithKline Biologicals0 sites600 target enrollmentDecember 11, 2008

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: For the prevention of high-grade cervical intraepithelial neoplasia (CIN grades 2 and 3) and cervical cancer causally related to human papillomavirus (HPV) types 16 and 18.
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 600
Status: Active, not recruiting
Last Updated: 10 years ago

No summary available.

Registry

who.int

Start Date

December 11, 2008

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 and/or their parents or legally acceptable representative (LAR) can and will comply with the requirements of the protocol (e.g. return for follow\-up visits) should be enrolled in the study.
•A female enrolled in the immunogenicity subset of study HPV\-013, who received three doses of HPV\-16/18 VLP/AS04 vaccine and participated in the long\-term follow\-up study Ext HPV\-013\.
•Written informed consent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from a parent or LAR and, in addition, the subject should sign a written informed assent form.
•Are the trial subjects under 18? yes
•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

•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).
•Use of any investigational or non\-registered product (drug or vaccine) or planned use during the study period.
•Administration or planned administration of any HPV vaccine, other than the three doses of HPV\-16/\-18 vaccine administered in study HPV\-013\.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune\-modifying drugs occurring within the three months preceding study entry. (For corticosteroids, this will mean prednisone \>\= 0\.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.)
•Administration of immunoglobulins and/or any blood products within the three months preceding study entry.