A phase IIIb, randomized, open, multicentre study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine (Cervarix™) co-administrated with GlaxoSmithKline Biologicals’ Hepatitis B vaccine (Engerix-B™) in healthy female subjects aged 9 - 15 years. - HPV-030 PRI

GlaxoSmithKline Biologicals0 sites756 target enrollmentFebruary 5, 2008

ConditionsFor the prevention of high grade cervical intraepithelial neoplasia (CIN grades 2 and 3) and cervical cancer causally related to Human Papillomavirus (HPV) types 16 and 18

DrugsCervarix™Engerix-B™

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: For the prevention of high grade cervical intraepithelial neoplasia (CIN grades 2 and 3) and cervical cancer causally related to Human Papillomavirus (HPV) types 16 and 18
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 756
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 5, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

GlaxoSmithKline Biologicals

Eligibility Criteria

Inclusion Criteria

•Subjects who the investigator believes that they and/or their parents/legally acceptable representatives (LARs) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow\-up visits) should be enrolled in the study.
•A female between, and including, 9 and 15 years of age (has not attained her 16th birthday) at the time of the first vaccination.
•Written informed consent obtained from the subject’s parent/LAR prior to the enrolment. In addition, written informed assent must be obtained from the subject.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•Subjects must not be pregnant. Absence of pregnancy should be verified with a urine pregnancy test.
•If the subject is female, she must be of non\-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post\-menopausal, or if she is of childbearing potential, she must practice adequate contraception for at least 30 days prior to vaccination, have a negative pregnancy test and 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:
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.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 within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 12\).
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune\-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone \>\= 0\.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.)
•Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e., Days 0 \- 29\) each dose of vaccine. Administration of routine vaccines such as meningococcal, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus\-containing vaccines up to 8 days before the first dose of study vaccine is allowed.
•Concurrently participating in another clinical study, at any time during the study period (up to the Month 12 telephone contact), in which the subject has been or will be exposed to an investigational or a non\-investigational product (pharmaceutical product or device).
•A subject 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.
•Previous vaccination against hepatitis B or planned administration of any hepatitis B vaccine other than that foreseen by the study protocol during the study period.
•History of hepatitis B infection.