Human Papilloma Virus Vaccine Safety and Immunogenicity Trial in Young Adolescent Women With GSK Bio HPV-16/18.

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: September 13, 2005
Last updated: November 21, 2012
Last verified: November 2012
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 safety and immunogenicity of GSK Biologicals HPV-16/18 vaccine over 12 months, in pre-teen and adolescent women of 10-14 years of age at study start. Approximately 2000 study subjects will receive the HPV vaccine or a control vaccine (hepatitis A 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: Evaluate the Safety & Immunogenicity of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly According to a 0,1,6 Mth Schedule in Healthy Female Subjects (10 - 14 Years)

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Demonstration of safety of the HPV vaccine compared to the control (occurrence of SAEs) up to month 7. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of HPV vaccine in entire study period. Vaccine immunogenicity. [ Designated as safety issue: No ]

Enrollment: 2067
Study Start Date: June 2004
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   10 Years to 14 Years   (Child)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

A woman between, and including, 10 and 14 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 identifier: NCT00196924

  Show 53 Study Locations
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Schwarz T et al. Long-term safety and immunogenicity of a human papillomavirus (HPV)-16/18 AS04 adjuvanted cervical cancer vaccine in girls aged 10-14 years: 36-month follow-up. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.
Rombo L et al. AS04 adjuvanted human papillomavirus (HPV) 16/18 L1 virus-like particle (VLP) vaccine for the prevention of cervical cancer is well-tolerated and immunogenic in 10- to 14-year-old adolescent girls. Abstract presented at the 24th Annual Meeting of the ESPID. Basel, Switzerland 3-5 May 2006.
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.
Schwarz TF et al. Long-term safety and immunogenicity of an AS04 adjuvanted cervical cancer vaccine in girls aged 10-14 years. Abstract presented at the 26th Annual Meeting of the ESPID. Graz, Austria, 13-17 May 2008.
Rombo L et al. Long-term safety and immunogenicity of a cervical cancer candidate vaccine in 10- to 14-year-old adolescent girls. Abstract presented at the 25th Annual Meeting of the ESPID. Porto, Portugal, 2-4 May 2007.
Brussels, Belgium, 9-13 June 2009. Schwarz TF et al. Safety and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine in adolescent girls: long-term follow-up of a randomised trial. Abstract presented at the 28th annual ESPID meeting, Nice, France, 4-8 May 2010.
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.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: GlaxoSmithKline Identifier: NCT00196924     History of Changes
Other Study ID Numbers: 580299/013 
Study First Received: September 13, 2005
Last Updated: November 21, 2012
Health Authority: Panama: Ministry of Health processed this record on August 23, 2016