A phase IIIb open, randomized multi-center study to evaluate the immunogenicity and safety of GSK Biologicals HPV-16/18 L1 VLP AS04 vaccine when administered intramuscularly according to an alternative dosing schedule at, 0, 1 and 12 months as compared to the standard dosing schedule at 0, 1 and 6 months in young healthy female subjects aged 15-25 years. - Immunogenicity and Safety Study of GSK Biologicals...

GLAXO SMITHKLINE0 个研究点目标入组 800 人开始时间: 2007年11月22日最近更新: 2012年3月19日

适应症

试验速览

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•Subjects who the investigator believes that they and/or their parent(s)/Legally acceptable representative(s) (LAR) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). · A female between and including 15 and 25 years of age at the time of the first vaccination. Written informed consent obtained from the subject prior to enrolment. For subjects below the legal age of consent, written informed consent must be obtained from the subject?s parents/legally acceptable representative (LAR), and written informed assent must be obtained from the subject. · Healthy subjects as established by medical history and/or clinical examination before entering into the study. · Subject must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of child bearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative urine pregnancy test and continue such precautions for 2 months after completion of the vaccination series. · Subject who had no more than 6 lifetime sexual partners prior to enrolment.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•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

•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. · 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, or equivalent, ³ 0.5 mg/kg/day. 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) the first dose of vaccine. Planned administration/administration of routine vaccines, such as meningococcal, hepatitis A or B, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccines, up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the patient is outside of specified window. · 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). · Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.

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