Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation.

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00250276
First received: November 7, 2005
Last updated: February 2, 2012
Last verified: January 2012

November 7, 2005
February 2, 2012
October 2005
March 2007   (final data collection date for primary outcome measure)
  • "• 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."
Same as current
Complete list of historical versions of study NCT00250276 on ClinicalTrials.gov Archive Site
• Evaluation of safety and reactogenicity throughout the entire study.
Same as current
Not Provided
Not Provided
 
Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation.
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Human Papillomavirus (HPV) Infection
  • Cervical Neoplasia
Biological: HPV-16/18 L1/AS04
Not Provided
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
798
March 2007
March 2007   (final data collection date for primary outcome measure)

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.
Female
18 Years to 25 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark,   Lithuania,   Poland
 
NCT00250276
104772
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP