A phase IIIb, randomized, open, multicentre study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals? HPV-16/18 L1 AS04 vaccine co-administered with GlaxoSmithKline Biologicals? combined reduced-antigen diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine (Boostrix® Polio) in healthy female subjects aged 10?18 years. - HPV-042

GlaxoSmithKline S.A.0 sites751 target enrollmentJune 8, 2012

ConditionsIn female subjects from 10 years of age onwards for the prevention of cervical cancer by protecting against incident and persistent infections, cytological abnormalities including ASC-US, cervical intraepithelial neoplasia (CIN) and pre-cancerous lesions caused by oncogenic human papillomaviruses (HPV).MedDRA version: 14.1Level: LLTClassification code 10063001Term: Human papilloma virus infectionSystem Organ Class: 10021881 - Infections and infestations Therapeutic area: Diseases [C] - Cancer [C04]

DrugsBoostrix® Polio

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: In female subjects from 10 years of age onwards for the prevention of cervical cancer by protecting against incident and persistent infections, cytological abnormalities including ASC-US, cervical intraepithelial neoplasia (CIN) and pre-cancerous lesions caused by oncogenic human papillomaviruses (HPV).
Sponsor: GlaxoSmithKline S.A.
Enrollment: 751
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 8, 2012

End Date

July 25, 2008

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

GlaxoSmithKline S.A.

Eligibility Criteria

Inclusion Criteria

•All subjects must satisfy the following criteria at study entry:
•? Subjects who the investigator believes that they and their parents/legally acceptable representatives (LAR) can, and will, comply with the requirements of the protocol should be enrolled in the study.
•? A female between, and including, 10 and 18 years of age at the time of the first vaccination.
•? Written informed consent/assent obtained from the subject, and written informed consent obtained from the subject?s parent/LAR, as appropriate.
•? Healthy subjects, as established by medical history and history\-directed physical examination, before entering into the study.
•? Previously completed routine childhood vaccinations against diphtheria, tetanus, pertussis and poliomyelitis diseases, according to the recommended vaccination schedule at the time.
•? Subjects must have a negative urine pregnancy test.
•? Subject must be of non\-childbearing potential i.e., have a current tubal ligation, hysterectomy, ovariectomy, or be pre\-menarcheal; or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. Subjects who reach menarche (begin menstruating) during the study, and therefore become of childbearing potential, must agree to follow the same precautions.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 665

Exclusion Criteria

•The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
•? 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.
•? Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non\-investigational product (pharmaceutical product or device).
•? Chronic administration (defined as more than 14 days) of immunosuppressants or other immune\-modifying drugs within six months prior to the first vaccine dose.
•? Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after each dose of vaccine(s).
•? A woman planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose.
•? Pregnant or breastfeeding women.
•? Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
•? Previous administration of MPL or AS04 adjuvant.
•? Administration of a diphtheria, tetanus, pertussis (DTP) vaccine, diphtheria\-tetanus (dT) booster or dTpa vaccine within the previous five years.