EUCTR2010-020227-48-PT进行中（未招募）1 期
A phase IIIb, open-label, multi-centre immunization study to evaluate the safety of GlaxoSmithKline (GSK) Biologicals’ HPV-16/18 L1 VLP AS04 vaccine administered intramuscularly according to a 0, 1, 6-month schedule in healthy female subjects who received the placebo control in the GSK HPV-015 study - HPV-066 EXT 015
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 650
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1/ Subjects who the investigator believes can and will comply with the requirements of the protocol
- •2/ A subject previously enrolled in the HPV-015 study, who received the control vaccine, and who cannot receive the commercially available HPV-16/18 L1 VLP AS04 vaccine because the subject is above the age for which the vaccine is licensed.
- •3/ Written informed consent obtained from the subject.
- •4/ Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- •5/ Female subjects of non-childbearing potential may be enrolled in the study.
- •Non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.
- •6/ Female subjects of childbearing potential may be enrolled in the study, if the subject:
- •- has practiced adequate contraception for 30 days prior to vaccination, and
- •- has a negative pregnancy test on the day of vaccination, and
- •- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
- •Are the trial subjects under 18? no
- •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
排除标准
- •1/ Pregnant or breastfeeding (women must be at least three months post-pregnancy and not breastfeeding to enter the study).
- •2/ A woman planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the vaccination phase of the study, i.e. up to two months after the last vaccine dose.
- •3/ 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.
- •4/ Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than that foreseen in the protocol.
- •5/ Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone greater than or equal to 20 mg/day, or equivalent. Inhaled and topical steroids are allowed
- •6/ Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days (i.e., Day 0-29) of each dose of vaccine, with the exception of administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine. Enrolment will be deferred until the subject is outside of specified window.
- •7/ 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).
- •NOTE: Subjects enrolled in this study may also be eligible for a four-year gynaecological follow-up of the HPV-015 study (HPV-062), in which no investigational product will be administered. Subjects may participate to both studies at the same time.
- •8/ Previous administration of MPL or AS04 adjuvant.
- •9/ Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •10/ Cancer or autoimmune disease under treatment.
- •11/ Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
- •12/ History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- •13/ History of any neurological disorders or seizures.
- •14/ Acute disease and/or fever at the time of enrolment.
- •Fever is defined as temperature = 37.5°C (99.5°F) on oral, axillary or tympanic setting, or = 38.0°C (100.4°F) on rectal setting.
- •Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
- •Enrolment will be deferred until condition is resolved.
- •15/ Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
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