NCT00485732已完成3 期
A Phase IIIb, Double-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV-16/18 L1 VLP AS04 Vaccine, Administered Intramuscularly in Healthy Female Subjects Aged 15 - 25 Years
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 7
- 主要终点
- Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
研究概览
简要总结
Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. The infection of the cervix by certain oncogenic types of HPV, if not cleared, can lead to cervical cancer in women. This study will evaluate the immunogenicity and safety of the GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine (Cervarix TM) vaccine.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that they or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- •A female between, and including, 15 and 25 years of age at the time of the first vaccination.
- •Written informed assent obtained from the subject and informed consent obtained from the parent or guardian of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Subjects must have a negative urine pregnancy test.
- •Subjects of childbearing potential at the time of study entry must be abstinent, or must be using adequate contraceptive precautions for 30 days prior to vaccination and must agree to continue such precautions for two months after completion of the vaccination series.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study/ control vaccine within 30 days preceding the first dose of study/ control vaccine, or planned use during the study period.
- •Pregnant or breastfeeding.
- •Planning to become pregnant or likely to become pregnant.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- •Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of vaccine. However, the administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
- •Previous administration of components of the investigational vaccine
- •Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
- •Any medically diagnosed or suspected immunodeficient condition such as HIV infection based on medical history and physical examination.
- •History of thrombocytopenia or hemostatic disorder in which case the study vaccine should under no circumstances be administered intramuscularly.
- •History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study/control vaccines.
- •Hypersensitivity to latex.
- •Known acute or chronic, clinically significant neurologic, pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
- •History of chronic condition(s) requiring treatment.
- •Administration of immunoglobulins and/or any blood product within three months preceding the first dose of study/control vaccine or planned administration during the study period. Enrolment will be deferred until the subject is outside of specified window.
- •Acute disease at the time of enrolment.
研究组 & 干预措施
Cervarix Group
Experimental
干预措施: HPV-16/18 VLP/AS04 vaccine (Cervarix TM) (Biological)
Placebo Group
Placebo Comparator
干预措施: Placebo (Biological)
结局指标
主要结局
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
时间窗: One month post Dose 3 (Month 7)
Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
次要结局
- Number of Subjects Reporting Solicited General Symptoms(During the 7-day (Days 0-6) period following each vaccination)
- Number of Subjects Reporting Serious Adverse Events (SAE)(From Day 0 up to Month 7)
- Number of Subjects With Pregnancies and Their Outcome(from Day 0 up to Month 7)
- Anti-HPV-16 and Anti-HPV-18 Antibody Titres(Before vaccination (PRE) and one month post Dose 3 (Month 7))
- Number of Subjects Reporting Solicited Local Symptoms(During the 7-day (Days 0-6) period following each vaccination)
- Number of Subjects Reporting Unsolicited Adverse Events (AE)(During the 30-day (Days 0-29) period following each vaccination)
- Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Medically Significant Conditions(From Day 0 up to Month 7)
研究者
研究点 (7)
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