Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00359619

Purpose

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also evaluating novel HPV vaccines formulations. This study will evaluate the long-term immunogenicity and safety of a novel GSK Biologicals vaccine in approximately 376 subjects who received the novel vaccine or the control vaccine administered in the primary study.

This protocol posting deals with objectives & outcome measures of the extension phase at month 18, 24, 36 & 48. The objectives & outcome measure of the primary phase are presented in a separate protocol posting (NCT00231413).

No new subjects will be enrolled in these extension phases. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Condition	Intervention	Phase
Cervical Neoplasia Papillomavirus Infections	Biological: Novel HPV vaccine (GSK568893A)	Phase I Phase II

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Long-Term, Follow-up of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Novel HPV Vaccine in Healthy Female Subjects Vaccinated in the Primary Study.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

HPV-16 and -18 seroconversion rates and GMTs [ Time Frame: At Months 18, 24, 36 and 48 ]

Secondary Outcome Measures:

Seroconversion rates and GMTs to other defined HPV serotypes [ Time Frame: At Months 18, 24, 36 and 48 ]
Occurrence of SAEs [ Time Frame: Through Month 48 ]
Occurrence of AEs related to NOCDs and other medically significant conditions [ Time Frame: Through Month 48 ]
Occurrence of pregnancy and pregnancy outcomes [ Time Frame: Through Month 48 ]

Estimated Enrollment:	376
Study Start Date:	September 2006
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 25 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

A female who enrolled in the study 102115 and received three doses of vaccine.
Written informed consent obtained from the subject prior to enrolment.

Exclusion Criteria:

Use (or planned use during the study period) of any investigational or non-registered product or off-label use of licensed product (drug or vaccine).
Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.
Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
Planned administration of any HPV vaccine, other than that foreseen by the study protocol, during the study period.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359619

Locations

United States, Colorado
GSK Clinical Trials Call Center
Golden, Colorado, United States
United States, Rhode Island
GSK Clinical Trials Call Center
Kingston, Rhode Island, United States
United States, Utah
GSK Clinical Trials Call Center
Salt Lake City, Utah, United States
Belgium
GSK Clinical Trials Call Center
Antwerpen, Belgium

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK Biologicals ( Isabelle Harpigny )
Study ID Numbers:	108052 (FU month 18), 107919 (FU month 24), 107921 (FU month 36), 107918 (FU month 48)
Study First Received:	July 18, 2006
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00359619
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

HPV vaccine
Prophylaxis against HPV infections and cervical neoplasia

Study placed in the following topic categories:

Virus Diseases
DNA Virus Infections
Papillomavirus Infections
Healthy

Additional relevant MeSH terms:

Tumor Virus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009