EUCTR2004-000518-37-ESActive, not recruitingPhase 1
A phase III, double-blind, randomized, controlled study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals? HPV-16/18 VLP/AS04 vaccine administered intramuscularly according to a 0, 1, 6 month schedule in healthy female subjects aged 10 ? 14 years. - HPV-013
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- GlaxoSmithKline SA
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •Female subjects 10 ? 14 years of age who have a negative urine pregnancy test at the time of the first vaccination. (If they are of childbearing potential at the time of study entry, they must be abstinent or must be using an effective method of birth control.)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 2000
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Pregnant or breastfeeding.
- •Planning to become pregnant or likely to become pregnant.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- •History of vaccination against hepatitis A or a known clinical history of hepatitis A infection.
Investigators
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