Human Papilloma Virus Vaccine Consistency and Non-inferiority Trial in Young Adult Women With GSK Bio HPV-16/18 - Full Text View

Purpose

Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes 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. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the consistency of consecutive vaccine lots and the non-inferiority of modified manufacturing processes of GSK Biologicals HPV-16/18 vaccine and the vaccine safety, over 12 months, in young adolescents and women of 10-25 years of age at study start. Approximately 750 study subjects will receive different lots of the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.

Condition	Intervention	Phase
Infections, Papillomavirus	Biological: HPV-16/18 L1/AS04	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Immunogenicity: 3 Consecutive Lots of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly at 0,1,6 Month Schedule in Healthy Females Aged 10-25 Years and Demonstrate Non-inferiority of Candidate HPV Vaccine Manufactured by Modified Production Process

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Demonstration of lot-to-lot consistency in terms of immunogenicity of 3 lots of HPV-16/18 vaccine.
Demonstration of non-inferiority in terms of immunogenicity of the HPV vaccine produced with a revised manufacturing process compared to the HPV vaccine produced with a previous manufacturing process

Secondary Outcome Measures:

Safety of HPV vaccine in entire study period. Immunogenicity bridge between pre-adolescent and adolescent population.


Enrollment:	770
Study Start Date:	September 2004
Study Completion Date:	July 2005
Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	10 Years to 25 Years (Child, Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

A woman between, and including, 10 and 25 years of age at the time of the first vaccination.
Written informed consent from the subject prior to enrolment.
Subject must be free of obvious health problems.
Subject must have negative urine pregnancy test.

Exclusion Criteria:

Pregnant or breastfeeding.
Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality.
History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, or autoimmune disease.
Previous vaccination against human papillomavirus (HPV).

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169494

Locations


Denmark
GSK Investigational Site
Koebenhavn NV, Denmark, 2400
GSK Investigational Site
Odense C, Denmark, 5000
Estonia
GSK Investigational Site
Tallinn, Estonia, 1162
GSK Investigational Site
Tartu, Estonia, 50417
Finland
GSK Investigational Site
Seinajoki, Finland, 60100
GSK Investigational Site
Tampere, Finland, 33200
Greece
GSK Investigational Site
Athens, Greece, 11527
GSK Investigational Site
Athens, Greece, 11528
GSK Investigational Site
Heraklion, Crete, Greece, 71110
GSK Investigational Site
Thessaloniki, Greece, 54642
Netherlands
GSK Investigational Site
Rotterdam, Netherlands, 3011 EN
GSK Investigational Site
Rotterdam, Netherlands, 3015 GE
Russian Federation
GSK Investigational Site
Kazan, Russian Federation, 420015
GSK Investigational Site
Moscow, Russian Federation, 115 478
GSK Investigational Site
Moscow, Russian Federation, 119991
GSK Investigational Site
Smolensk, Russian Federation, 214018
GSK Investigational Site
Volgograd, Russian Federation, 400130

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

Month 18 FU This link exits the ClinicalTrials.gov site

Month 24 FU This link exits the ClinicalTrials.gov site

Month 36 FU This link exits the ClinicalTrials.gov site

Month 48 FU This link exits the ClinicalTrials.gov site

Study Data/Documents: Informed Consent Form This link exits the ClinicalTrials.gov site