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Human Papilloma Virus Vaccine Consistency and Non-Inferiority Trial in Young Adult Women With GSK Bio HPV-16/18
This study has been completed.
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00169494
  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
HPV-16/18 Infections
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, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title: Immunogenicity: 3 Consecutive Lots of GSK Bios’ HPV-16/18 Vaccine Admnd Intramuscularly at 0,1,6 Mth Schedule in Healthy Females Aged 10–25 y & 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.

Estimated Enrollment: 750
Study Start Date: September 2004
  Eligibility

Ages Eligible for Study:   10 Years to 25 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00169494

Locations
Denmark
Odense,, Denmark
Copenhagen,, Denmark
Estonia
Tartu,, Estonia
Tallinn,, Estonia
Finland
Tampere,, Finland
Seinajoki, Finland
Greece
Athens,, Greece
Thessaloniki,, Greece
Heraklion,, Greece
Netherlands
Rotterdam, Netherlands
Russian Federation
Moscow,, Russian Federation
Smolensk,, Russian Federation
Volgograd, Russian Federation
Kazan,, Russian Federation
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: Clinical Trials GlaxoSmithKline
  More 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 ID Numbers: 580299/012
Study First Received: September 12, 2005
Last Updated: January 19, 2007
ClinicalTrials.gov Identifier: NCT00169494  
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Study placed in the following topic categories:
Virus Diseases
Healthy
Papilloma

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on January 13, 2009