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

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 Biological's 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 Biological's vaccine in approximately 376 subjects who received the novel vaccine or the control vaccine administered in the primary study.

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

Condition	Intervention	Phase
Prophylaxis for HPV Infections and Cervical Neoplasia	Biological: CervarixTM Biological: HPV investigational vaccine GSK568893A, different formulations	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Seroconversion rates and GMTs to other defined HPV serotypes [ Time Frame: At Months 18, 24, 36 and 48 ] [ Designated as safety issue: No ]
Occurrence of SAEs [ Time Frame: Through Month 48 ] [ Designated as safety issue: No ]
Occurrence of AEs related to NOCDs and other medically significant conditions [ Time Frame: Through Month 48 ] [ Designated as safety issue: No ]
Occurrence of pregnancy and pregnancy outcomes [ Time Frame: Through Month 48 ] [ Designated as safety issue: No ]

Enrollment:	166
Study Start Date:	September 2006
Study Completion Date:	August 2009
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group A Subjects receiving different dosage combination of the novel formulation of HPV-vaccine	Biological: HPV investigational vaccine GSK568893A, different formulations Subjects were administered three doses of HPV investigational vaccine
Experimental: Group B Subjects receiving different dosage combination of the novel formulation of HPV-vaccine	Biological: HPV investigational vaccine GSK568893A, different formulations Subjects were administered three doses of HPV investigational vaccine
Experimental: Group C Subjects receiving different dosage combination of the novel formulation of HPV-vaccine	Biological: HPV investigational vaccine GSK568893A, different formulations Subjects were administered three doses of HPV investigational vaccine
Experimental: Group D Subjects receiving different dosage combination of the novel formulation of HPV-vaccine	Biological: HPV investigational vaccine GSK568893A, different formulations Subjects were administered three doses of HPV investigational vaccine
Experimental: Group E Subjects receiving different dosage combination of the novel formulation of HPV-vaccine	Biological: HPV investigational vaccine GSK568893A, different formulations Subjects were administered three doses of HPV investigational vaccine
Active Comparator: Group F Subjects receiving the (HPV-16/18L1AS04) CervarixTM vaccine	Biological: CervarixTM Subjects were administered three doses of HPV vaccine

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 Investigational Site
Denver, Colorado, United States, 80262
GSK Investigational Site
Golden, Colorado, United States, 80401
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84121
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
Belgium
GSK Investigational Site
Bruxelles, Belgium, 1070
GSK Investigational Site
Gent, Belgium, 9000
GSK Investigational Site
Leuven, Belgium, 3000
GSK Investigational Site
Liège, Belgium, 4000
GSK Investigational Site
Tienen, Belgium, 3300

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00359619 History of Changes
Obsolete Identifiers:	NCT00359502, NCT00359528, NCT00359827
Other Study ID Numbers:	108052 (FU month 18), 107919, 107921, 107918
Study First Received:	July 18, 2006
Last Updated:	November 10, 2011
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

HPV vaccine

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013