NCT00996125已完成3 期
Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) 580299 Vaccine in Healthy Chinese Female Subjects
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Geometric Mean Titers (GMTs) for Antibodies Against Human Papillomavirus (HPV)-16/18 Antigens
研究概览
简要总结
This study is designed to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals' human papillomavirus (HPV) vaccine in pre-teen and adolescent female subjects aged 9 - 17 years. One group of subjects will receive the HPV vaccine and the other group will receive the control.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 9 Years 至 17 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that they or their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
- •Healthy Chinese females between and including 9 and 17 years of age at the time of the first vaccination.
- •Written informed consent obtained from the parent(s)/LAR(s) of the subject and informed assent obtained from the subject, if appropriate, prior to enrolment.
- •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 before each vaccination.
- •Subjects must be either of non-childbearing potential, or if of childbearing potential, they must be abstinent or have practiced adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and agree to continue such precautions for 2 months after completion of the vaccination series.
排除标准
- •Use of any investigational or non-registered product other than the study vaccines 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.
- •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) the first dose of vaccine.
- •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.
- •A subject planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose.
- •Pregnant or breastfeeding. Subjects must be at least three months post-pregnancy and not breastfeeding to enter the study.
- •Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the protocol during the study period.
- •Previous administration of components of the study vaccine.
- •History of chronic condition(s) requiring treatment such as cancer or autoimmune disease.
- •History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the vaccine.
- •Hypersensitivity to latex.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Acute disease at the time of enrolment.
- •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.
研究组 & 干预措施
Cervarix Group
Experimental
Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
干预措施: CervarixTM (Biological)
Placebo Group
Experimental
Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
干预措施: Control (Other)
结局指标
主要结局
Geometric Mean Titers (GMTs) for Antibodies Against Human Papillomavirus (HPV)-16/18 Antigens
时间窗: One month after the third dose (at Month 7)
Titers were given as geometric mean titers and were measured by Enzyme-linked Immunosorbent Assay (ELISA) and expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
次要结局
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms(During the 7 days (Days 0 - 6) following each vaccination)
- Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies(At Month 7)
- Number of Subjects Reporting Pregnancies and Pregnancy Outcomes(Throughout the study period (from Day 0 up to Month 12))
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms(During the 7 days (Days 0 - 6) following each vaccination)
- Number of Subjects Reporting Medically Significant Conditions (MSCs)(Throughout the study period (from Day 0 up to Month 12))
- Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)(Throughout the study period (from Day 0 up to Month 12))
- Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(Within 30 days (Days 0 - 29) after any vaccination)
研究者
研究点 (1)
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