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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.
First Received: September 13, 2005   Last Updated: October 9, 2006   History of Changes
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00196924
  Purpose

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
HPV-16/18 Infections
Cervical Neoplasia
Biological: HPV-16/18 L1/AS04
Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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)

Resource links provided by NLM:


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.

Secondary Outcome Measures:
  • Safety of HPV vaccine in entire study period. Vaccine immunogenicity.

Estimated Enrollment: 2000
Study Start Date: June 2004
  Eligibility

Ages Eligible for Study:   10 Years to 14 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00196924

  Show 51 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: Clincal Trials GlaxoSmithKline
  More Information

No publications provided

Study ID Numbers: 580299/013
Study First Received: September 13, 2005
Last Updated: October 9, 2006
ClinicalTrials.gov Identifier: NCT00196924     History of Changes
Health Authority: Panama: Ministry of Health

Study placed in the following topic categories:
Virus Diseases
Healthy
Papilloma

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on September 03, 2009