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Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Administered Intramuscularly According to a 0,1,6 Mth Schedule in Healthy Female Subjects Aged 10-14 Yrs


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

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Trial Information

Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Administered Intramuscularly According to a 0,1,6 Mth Schedule in Healthy Female Subjects Aged 10-14 Yrs


Study participants will receive either HPV or hepatitis A vaccine, study duration will last
for 7 months and involve a total of 4 visits.

Inclusion Criteria


Inclusion criteria:

- A female subject between, and including, 10 and 14 years of age at the time of the
first vaccination.

- Written informed assent from the subject and informed consent from the parent or
guardian of the subject should be obtained prior to enrolment.

- Subjects must have a negative urine pregnancy test.

- Healthy subject before entering the study as established by medical history and
clinical examination.

- Subject must be of non-childbearing potential.

Exclusion criteria:

- Pregnant or breastfeeding.

- Previous vaccination against HPV.

- Known acute or chronic, clinically significant neurologic, hepatic or renal
functional abnormality

- History of chronic condition(s) requiring treatment such as cancer, chronic hepatic
or kidney disease(s), diabetes, or autoimmune disease."

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

To evaluate antibody responses against HPV-16 and HPV-18 in all HPV vaccine recipients at Month 7.

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Korea: Food and Drug Administration

Study ID:

104951

NCT ID:

NCT00290277

Start Date:

November 2005

Completion Date:

Related Keywords:

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

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