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A Dose-range Study to Assess the Safety & Immunogenicity of a Novel HPV Vaccine When Administered Intramuscularly According to a 3-dose Schedule (0,1,6-mth) in Healthy Adult Females (18-25 Yrs of Age)


Phase 2
18 Years
25 Years
Not Enrolling
Female
Human Papillomavirus (HPV) Infection, Cervical Neoplasia

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Trial Information

A Dose-range Study to Assess the Safety & Immunogenicity of a Novel HPV Vaccine When Administered Intramuscularly According to a 3-dose Schedule (0,1,6-mth) in Healthy Adult Females (18-25 Yrs of Age)


Inclusion Criteria:



- A woman between, and including, 18 and 25 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 be of non-childbearing potential and have had no more than 6 lifetime
sexual partners.

Exclusion Criteria:

- Pregnant or breastfeeding.

- A woman planning to become pregnant or planning to discontinue contraceptive
precautions during approximately the first nine months of the study (Month 0-8).

- 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, Primary Purpose: Prevention

Outcome Measure:

Evaluation of immune response of the novel HPV vaccine at different dosages at month 7.

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:

102115

NCT ID:

NCT00231413

Start Date:

March 2005

Completion Date:

March 2006

Related Keywords:

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

Name

Location

GSK Investigational SiteAurora, Colorado  80012
GSK Investigational SiteCranston, Rhode Island  02920
GSK Investigational SiteSalt Lake City, Utah  84107