Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GSK Biologicals' (GSK Bio) HPV-16/18 Vaccine

Phase 1

• Conditions: cervical cancer: the study is conducted in healthy female adolescents; MedDRA version: 14.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2004-000518-37-ES
• Lead Sponsor: GlaxoSmithKline SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2009-01-20
• Study Start: 2012-06-08
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 0

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified