Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine 580299 When Administered as a 3-dose Schedule in Healthy Japanese Pre-adolescent and Adolescent Female Subjects.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Number of Subjects Reporting Solicited Local Symptoms
研究概览
简要总结
Human papillomavirus (HPV) infection has been established as a necessary cause of cervical cancer. GSK Biologicals has developed an HPV vaccine (580299) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in approximately 70% of all cervical cancers. In previous trials, the vaccine has been found to be efficacious in the prevention of incident and persistent HPV-16/18 infections and associated cytological abnormalities. HPV vaccination should ideally be performed before onset of sexual activity. Previous studies showed that GSK Biologicals' HPV vaccine 580299 is safe and immunogenic when administered to European, Asian, Latin American and Australian pre-adolescents and adolescents. Here, we aim to assess the immunogenicity and safety of the GSK Biologicals' HPV vaccine 580299 in healthy Japanese pre-adolescent and adolescent female subjects aged 10-15 years. 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
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 15 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator/co-investigator believes that they and/or their parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol should be enrolled in the study.
- •A Japanese female between, and including, 10 and 15 years of age at the time of the first vaccination.
- •Written informed consent obtained from the parent(s) or legally acceptable representative(s) of the subject. In addition, a written informed assent must be obtained from the subject prior to enrolment.
- •Healthy subjects as established by medical history and history-directed clinical examination before entering into the study.
- •All subjects must have a negative urine pregnancy test.
- •Subjects must be of non-childbearing potential, or, if of childbearing potential, they must be abstinent or have used adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. Non-abstinent pre-menarche subjects, as well as subjects who reach menarche during study, must follow the same precautions.
排除标准
- •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.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose or planned during study.
- •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. Administration of 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.
- •Concurrently participating in another clinical study, at any time during the study period (up to Month 7), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- •Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (Day 0 to Month 7).
- •Previous administration of components of the investigational vaccine .
- •Cancer or autoimmune disease under treatment.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Hypersensitivity to latex.
- •Acute disease at the time of enrolment.
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
- •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.
- •Pregnant or breastfeeding subject.
- •Subject planning to become pregnant or planning to discontinue contraceptive precautions.
- •Oral temperature ≥ 37.5°C/Axillary temperature ≥ 37.5°C.
研究组 & 干预措施
Cervarix
Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
干预措施: Cervarix™ (HPV-16/18 L1 VLP AS04) (Biological)
结局指标
主要结局
Number of Subjects Reporting Solicited Local Symptoms
时间窗: During the 7-day (Days 0-6) period following each vaccination
Solicited local symptoms assessed include pain, redness and swelling.
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.
Anti-HPV-16 and Anti-HPV-18 Antibody Titers
时间窗: Before vaccination (PRE) and one month post Dose 3 (Month 7)
Titers are given as geometric mean titers (GMTs) calculated on all subjects.
Number of Subjects Reporting Solicited General Symptoms
时间窗: During the 7-day (Days 0-6) period following each vaccination
Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.
次要结局
- Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions(From Day 0 up to Month 7)
- Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters(At Day 0 and Month 7)
- Outcome of All Pregnancies(Up to Month 7)
- Number of Subjects Reporting Serious Adverse Events (SAEs)(From Day 0 up to Month 7)
- Number of Subjects Reporting Unsolicited Adverse Events (AE)(During the 30-day (Days 0-29) period following each vaccination)