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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00169494
First received: September 12, 2005
Last updated: September 29, 2011
Last verified: September 2011
  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
Human Papillomavirus (HPV) Infection
Cervical Neoplasia
Biological: HPV-16/18 L1/AS04
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


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. [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of HPV vaccine in entire study period. Immunogenicity bridge between pre-adolescent and adolescent population. [ Designated as safety issue: No ]

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
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
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:
Publications:
Petaja T et al. Long-term persistence of immune response to HPV-16/18 ASO4-adjuvanted cervical cancer vaccine in preteen/adolescent girls and young women. Abstract presented at European Research Organization on Genital Infection and Neoplasia 2010 (EUROGIN). Monte Carlo, Monaco, 17-20 February 2010.
Rombo L et al. Tolerability of HPV-16/18 AS04-adjuvanted cervical cancer vaccine. Abstract presented at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) International Multidisciplinary Conference. Nice, France, 12-15 November 2008.
Descamps D et al. (2009) Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: A pooled analysis of 11 clinical trials. Hum Vaccin. 5(5):51-59.

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00169494     History of Changes
Other Study ID Numbers: 580299/012
Study First Received: September 12, 2005
Last Updated: September 29, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 24, 2014