EUCTR2011-002035-26-FR进行中（未招募）1 期
A Phase IIIb observer-blind, randomized, multicentre primary immunization study to evaluate the immunogenicity and safety of GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine and Merck's Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, when administered intramuscularly according to alternative 2-dose schedules in 9-14 year old healthy females. - HPV-071 PRI
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,079
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 can and will comply with the requirements of the protocol and subjects who the investigator believes their parent(s)/Legally Acceptable Representative(s) (LAR[s]) can and will comply with the requirements of the protocol.
- •- A female between, and including, 9 and 14 years of age at the time of the first vaccination.
- •- Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to enrolment in the study. In addition, if capable, the subject should sign and personally date a written informed assent.
- •- Healthy subjects as established by medical history and clinical examination before entering into the study.
- •- Female subjects of non-childbearing potential may be enrolled in the study.
- •- 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 two months after completion of the vaccination series.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1074
- •F.1.2 Adults (18-64 years) no
- •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
- •- Pregnant or breastfeeding.
- •- 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.
- •- Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than those foreseen in the protocol.
- •- Child in care.
- •- 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 36).
- •- Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- •- History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines.
- •- Cancer or autoimmune disease under treatment.
- •- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before each dose of vaccine. 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 is allowed. Enrolment will be deferred until the subject 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 administration of vaccine components.
- •- 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.
- •- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •- Family history of congenital or hereditary immunodeficiency.
- •- Major congenital defects or serious chronic illness.
- •- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator precludes administration of the study vaccine.
- •- Acute disease and/or fever at the time of enrolment.
- •Fever is defined as temperature = 37.5°C on oral, axillary or tympanic setting, or = 38.0°C 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 can be deferred until condition is resolved.
- •- Drug and/or alcohol abuse.
研究者
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