Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV Vaccine in Healthy Women Aged 18-35 Years - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00345878

Purpose

Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. The infection of the cervix by certain oncogenic types of HPV, if not cleared, can lead to cervical cancer in women. This study will evaluate the immunogenicity and safety of the HPV-16/18 L1 VLP AS04 vaccine.

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

Condition	Intervention	Phase
Human Papillomavirus (HPV) Infection Associated Cervical Neoplasia	Biological: HPV-16/18 L1 VLP AS04	Phase III

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase IIIb, Double-Blind, Randomized, Controlled Study to Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine Administered Intramuscularly ( 0, 1, 6 Month Schedule) in Healthy Women From Malaysia.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Seroconversion rates to HPV-16 and HPV-18 [ Time Frame: At Month 7 ]

Secondary Outcome Measures:

Occurrence of SAEs [ Time Frame: Throughout the study period (up to Month 7) ]
Occurrence, intensity and relationship to vaccination of solicited general symptoms, and occurrence and intensity of solicited local symptoms [ Time Frame: During the 7 days after each and any vaccination ]
Occurrence, intensity and causal relationship to vaccination of unsolicited symptoms [ Time Frame: Within 30 days after any vaccination ]
Occurrence of new onset chronic diseases (e.g. autoimmune disorders, asthma, type I diabetes, allergies, etc.) and other medically significant conditions regardless of causal relationship to vaccination and intensity. [ Time Frame: Throughout the study period (up to Month 7) ]
Anti-HPV-16/18 antibody titres [ Time Frame: At Month 0 and Month 7 ]

Estimated Enrollment:	300
Study Start Date:	September 2006
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Detailed Description:

The protocol was primarily amended for the following reasons:

Merck's tetravalent HPV vaccine, Gardasil®, has been licensed and is now becoming commercially available in an increasing number of countries. Therefore, the study procedures were revised to include questions at every visit to determine if subjects have received an HPV vaccine outside of the study.
It was decided to offer GSK Biologicals' HPV vaccine to all subjects in the control group at the end of the study. The HPV vaccine will be offered to these subjects based on its local indication once the vaccine is marketed in Malaysia.

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
A female from Malaysia between, and including, 18 and 35 years of age at the time of the first vaccination.
Written informed consent obtained from the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Subjects must have a negative urine pregnancy test.
Subjects of childbearing potential at the time of study entry must be abstinent or must be using an effective method of birth control for 30 days prior to vaccination and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of vaccine. Administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
previous administration of components of the investigational vaccine
Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
Hypersensitivity to latex.
Acute disease at the time of enrolment.
Known acute or chronic, clinically significant neurologic, pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
History of chronic condition(s) requiring treatment.
Administration of immunoglobulins and/or any blood product within three months preceding the first dose of study vaccine(s) or planned administration during the study period. Enrolment will be deferred until the subject is outside of specified window.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345878

Locations

Malaysia
GSK Investigational Site
Kuala Lumpur, Malaysia, 50603
GSK Investigational Site
Kerajaan Persekutuan Putrajaya, Malaysia, 62250

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	105926
Study First Received:	June 28, 2006
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00345878
Health Authority:	Malaysia: Ministry of Health

Keywords provided by GlaxoSmithKline:

HPV
HPV-16/18 L1 VLP AS04
AS04

Cervical cancer
Cervical neoplasia
Double-blind

Study placed in the following topic categories:

Healthy

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on January 13, 2009