EUCTR2007-007876-41-BE进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •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
- •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
- •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.
- •Known exposure to hepatitis B within the previous 6 weeks.
- •Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
- •Cancer or autoimmune disease under treatment.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines (e.g. aluminum, yeast, neomycin, formaldehyde, MPL, phenoxyethanol).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral/axillary temperature <37.5°C).
- •Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. Enrolment will be postponed until the subject is outside the specified window.
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