A phase IIIb, randomized, open study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ Hepatitis B vaccine (Engerix-B™) when co-administered with GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine (Cervarix™) in healthy female subjects aged 20 to 25 years - HPV-026 PRI

GlaxoSmithKline Biologicals0 sites0 target enrollmentFebruary 20, 2008

ConditionsCervarix™ is indicated 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.

DrugsCervarix™Engerix™-B

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Cervarix™ is indicated 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
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

February 20, 2008

End Date

June 18, 2009

Last Updated

4 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 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, 20 and 25 years of age at the time of the first vaccination.
•Written informed consent obtained from the subject.
•Healthy subjects as established by medical history and history directed clinical examination before entering into the study.
•Subjects must not be pregnant. Absence of pregnancy will be verified with a urine pregnancy test.
•Subjects must be of non\-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post\-menopausal, or if of childbearing potential, subjects must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
•Adequate contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly (when applicable, as mentioned in the product label) for example abstinence, combined or progestogen oral contraceptives, injectable progestogen, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches or intrauterine device (IUD) or intrauterine system (IUS), vasectomy with documented azoospermia of the sole male partner or double barrier method (condom or occlusive cap plus spermicidal agent).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

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.
•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, inactivated polio, 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 Month 1213\), 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.