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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)


Phase 3
10 Years
14 Years
Not Enrolling
Female
Human Papillomavirus (HPV) Infection, Cervical Neoplasia

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Trial Information

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)


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).

Type of Study:

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

Outcome Measure:

Demonstration of safety of the HPV vaccine compared to the control (occurrence of SAEs) up to month 7.

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Panama: Ministry of Health

Study ID:

580299/013

NCT ID:

NCT00196924

Start Date:

June 2004

Completion Date:

March 2006

Related Keywords:

  • Human Papillomavirus (HPV) Infection
  • Cervical Neoplasia
  • Neoplasms

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