Trial record 2 of 15 for:    cervical cancer and LOT

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

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

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 3

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

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 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.

Enrollment: 798
Study Start Date: October 2005
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)

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

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 identifier: NCT00250276

GSK Investigational Site
Hvidovre, Denmark, DK-2650
GSK Investigational Site
Klaipeda, Lithuania, LT-93200
GSK Investigational Site
Vilnius, Lithuania, LT-07156
GSK Investigational Site
Vilnius, Lithuania, LT-10207
GSK Investigational Site
Krakow, Poland, 31-501
GSK Investigational Site
Poznan, Poland, 60-533
GSK Investigational Site
Warszawa, Poland, 01-211
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

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.

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure Identifier: NCT00250276     History of Changes
Other Study ID Numbers: 104772
Study First Received: November 7, 2005
Last Updated: February 2, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms processed this record on April 17, 2014