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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00196924
First received: September 13, 2005
Last updated: November 21, 2012
Last verified: November 2012
History of Changes

September 13, 2005
November 21, 2012
June 2004
March 2006   (final data collection date for primary outcome measure)
Demonstration of safety of the HPV vaccine compared to the control (occurrence of SAEs) up to month 7. [ Designated as safety issue: No ]
Demonstration of safety of the HPV vaccine compared to the control (occurrence of SAEs) up to month 7.
Complete list of historical versions of study NCT00196924 on ClinicalTrials.gov Archive Site
Safety of HPV vaccine in entire study period. Vaccine immunogenicity. [ Designated as safety issue: No ]
Safety of HPV vaccine in entire study period. Vaccine immunogenicity.
Not Provided
Not Provided
 
Human Papilloma Virus Vaccine Safety and Immunogenicity Trial in Young Adolescent Women With GSK Bio HPV-16/18.
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)

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2067
March 2006
March 2006   (final data collection date for primary outcome measure)

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).
Female
10 Years to 14 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia,   Colombia,   Czech Republic,   France,   Germany,   Honduras,   Korea, Republic of,   Norway,   Panama,   Spain,   Sweden,   Taiwan
 
NCT00196924
580299/013
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2012

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