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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)

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   (Adult)
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
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 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. Safety of human papillomavirus (HPV)-16/18 AS04 adjuvanted vaccine for cervical cancer prevention: integrated summary of 11 clinical trials. Abstract presented at the 26th Annual Meeting of the ESPID. Graz, Austria, 13-17 May 2008.
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 processed this record on October 20, 2016