EUCTR2011-005604-15-Outside-EU/EEA进行中（未招募）不适用
A phase III, randomised, controlled, single-blind study to evaluate the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ HPV-16/18 L1 VLP AS04 vaccine administered according to a 2-dose schedule (0, 6 month) in 4-6 years old healthy female children. - HPV-073
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 148
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 parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
- •A female between, and including, 4 and 6 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.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Subjects who received four doses of DTP vaccine (i.e., three doses in the first year of life and a fourth dose in the second year of life) according to the schedule applicable in the participating countries.
- •Subjects who received a first dose of MMR vaccine according to the schedule applicable in the participating countries.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 148
- •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
- •Child in care.
- •Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than that foreseen in the protocol.
- •Planned administration/administration of a vaccine not fore-seen by the study protocol within 30 days before the first dose of study vaccine(s). Administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza and/or poliomyelitis vaccines up to 8 days before the first dose of study vaccine(s) is allowed. Enrolment will be deferred until the subject is outside of specified window.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days pre-ceding the first dose of study vaccine(s), or planned use during the study period.
- •History of any reactions or hypersensitivity likely to be exac-erbated by any component of the study vaccines, including latex and/or obvious allergic reactions to neomycin (a history of contact dermatitis to neomycin is not a contraindication), egg protein, etc. (e.g. hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock subsequent to egg ingestion).
- •Cancer or autoimmune disease under treatment.
- •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 MPL or AS04 adjuvant.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine(s) or planned administration during the study period.
- •Any confirmed or suspected immunosuppressive or immu-nodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •Family history of congenital or hereditary immunodeficiency.
- •Documented human immunodeficiency virus (HIV)-positive subject.
- •Major congenital defects or serious chronic illness.
- •History of seizures or serious neurological disorder, which, according to the judgment of the investigator, precludes ad-ministration of any of the study vaccines.
- •Acute or chronic, clinically significant pulmonary, cardiovas-cular, 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(s).
- •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.
- •Previous administration of the fifth dose of DTP vaccine and/or the second dose of MMR vaccine or planned administration of DTP vaccine and/or MMR vaccine outside the study (during the study period from Day 0 to Month 12).
- •History of tetanus, diphtheria, pertussis, measles, mumps and/or rubella.
- •Known exposure to diphtheria or household exposure to pertussis within 30 days prior to vaccination with DTPa.
- •Known exposure to measles, mumps and/or rubella 30 days prior to vaccination with the MMR study vaccine.
- •Confirmed or suspected tuberculosis.
- •Severe allergic reactions (e.g. anaphylaxis or severe Arthus-type hypersensitivity rea
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