Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation. - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00250276

Purpose

Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will compare the immune response induced by different lots of the HPV-16/18 L1/AS04 vaccine, following adjustments to the manufacturing process.

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

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Parallel Assignment, Bio-equivalence Study
Official Title:	Assess Lot-to-Lot Consistency of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Following Manufacturing Adjustments Administered Intramuscularly According to a 0,1,6-Mth Schedule in Healthy Female Subjects (18-25 y)

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

"• Demonstration of lot-to-lot consistency in terms of immunogenicity between different lots of HPV-16/18 L1/AS04 vaccine.
• Demonstration of non-inferiority in terms of immunogenicity of the adapted manufacturing process compared to the previous manufacturing process."

Secondary Outcome Measures:

• Evaluation of safety and reactogenicity throughout the entire study.

Estimated Enrollment:	780
Study Start Date:	October 2005

Eligibility

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

Criteria

"Inclusion criteria:

A female subject between, and including, 18 and 25 years of age at the time of the first vaccination.
Written informed consent obtained from the subject prior to enrolment.
Subject must have a negative urine pregnancy test.
Healthy subject before entering the study entry as established by medical history and physical examination.
Subject must be of non-childbearing potential.

Exclusion criteria:

pregnant or breastfeeding subject.
previous vaccination against human papillomavirus (HPV).
Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality.
History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes or autoimmune disease."

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250276

Locations

Denmark
GSK Investigational Site
Hvidovre, Denmark, DK-2650
Lithuania
GSK Investigational Site
Vilnius, Lithuania, LT-10207
GSK Investigational Site
Klaipeda, Lithuania, LT-93200
GSK Investigational Site
Vilnius, Lithuania, LT-07156
Poland
GSK Investigational Site
Warszawa, Poland, 01-211
GSK Investigational Site
Poznan, Poland, 60-533
GSK Investigational Site
Krakow, Poland, 31-501

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	104772
Study First Received:	November 7, 2005
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00250276
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Healthy

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on January 16, 2009