Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GSK Biologicals' (GSK Bio) HPV-16/18 Vaccine - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00316706

Purpose

This protocol posting deals with objectives & outcome measures of the extension phase up to Month 48. The objective of the extension study is to evaluate the long-term immunogenicity of the HPV 16/18 L1 VLP AS04 vaccine (for all subjects in the HPV Vaccine Group) by enzyme-linked immunosorbent assay (ELISA).The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924).

The long-term follow-up study will be blinded until the primary study is unblinded and will be open for all visits subsequent to unblinding of 580299-013. During the open phase, only subjects who received the HPV-16/18 VLP/AS04 vaccine during the 580299-013 study will continue their participation in the follow-up study until Month 48. Subjects in the Control group (Havrix®) will attend one further visit as their last study visit.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Condition	Intervention	Phase
Papillomavirus Infections Cervical Intraepithelial Neoplasia	Biological: HPV-16/18 L1/AS04	Phase III

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Long-Term, Open Follow-up of the Immunogenicity and Safety of GSK Biologicals' HPV Vaccine (580299) in Healthy Female Subjects Vaccinated in Study HPV-013

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Anti-HPV-16/18 antibody titers in all study subjects in the HPV Vaccine group

Secondary Outcome Measures:

Immunogenic evaluation of the vaccine component.
Anti-HPV-16/18 antibody titers (ELISA) from HPV-001 subjects.
Occurrence of pregnancies, serious adverse events, new onset chronic diseases, and conditions prompting emergency room visits or physician visits that are not related to common diseases [ Time Frame: Throughout the entire study period ]

Estimated Enrollment:	1400
Study Start Date:	October 2005
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	10 Years to 14 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

A female who enrolled in the immunological subset of the 580299-013 study, received the three doses of vaccine/control according to the treatment allocation and completed the 580299-013 study.
Written informed assent obtained from the subject and written informed consent obtained from a parent or legally acceptable representative of the subject.

Exclusion Criteria:

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.
Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than 3 months prior to blood sampling.
Administration of immunoglobulins and/or any blood products within the 3 months preceding blood sampling.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316706

Locations

Colombia

Bogota, Colombia
Germany

Berlin, Germany
Honduras

Tegucigalpa, Honduras
Panama

Panama City, Panama
Taiwan

Taipei, Taiwan

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK Biologicals ( Isabelle Harpigny )
Study ID Numbers:	104896 (month 18 FU), 104902 (month 24 FU), 104904 (month 36 FU), 104918 (month 48 FU)
Study First Received:	April 19, 2006
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00316706
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Prophylaxis HPV-16/18 infections and cervical neoplasia

Study placed in the following topic categories:

Virus Diseases
Cervical intraepithelial neoplasia
Carcinoma in Situ
DNA Virus Infections
Papillomavirus Infections

Healthy
Papilloma
Neoplasms, Glandular and Epithelial
Carcinoma
Cervical Intraepithelial Neoplasia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Tumor Virus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009