Immunogenicity and Safety Study of GSK Biologicals' HPV Vaccine (GSK 580299) in Healthy Adult Chinese Female Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,212
- 试验地点
- 1
- 主要终点
- Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) and HPV-18
研究概览
简要总结
This study is designed to evaluate the immunogenicity and safety of GSK Biologicals' human papillomavirus (HPV) vaccine in adult female subjects aged 26-45 years. One group of subjects will receive the HPV vaccine and the other group will receive an active control (GSK Biologicals' hepatitis B vaccine). Immunogenicity data of the HPV group will be compared with those from the HPV group included in the NCT00779766 study (aged 18-25 years).
详细描述
This Protocol Posting has been updated following Protocol Amendment 1, December 2010, leading to:
- The removal of 3 outcome measures
- The update of 1 outcome measure
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 26 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Written informed consent prior to study enrolment.
- •Healthy adult females from Chinese origin and residing in China between and including 26 and 45 years of age at the time of the first vaccination.
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- •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 of non-childbearing potential, i.e., have a current tubal ligation, hysterectomy, ovariectomy, be one year post-menopausal, 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 on the day of vaccination and agree to continue such precautions during the entire treatment period and 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 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 (pharmaceutical product or device).
- •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 3-O-desacyl-4'-monophosphoryl lipid A or AS04 adjuvant.
- •Previous vaccination against hepatitis B or planned administration of any hepatitis B vaccine other than that foreseen by the study protocol during the study period.
- •History of hepatitis B infection.
- •Known exposure to hepatitis B within the previous 6 weeks.
- •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 (e.g. aluminium).
- •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 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
Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
干预措施: GSK580299 (CervarixTM) (Biological)
Engerix Group
Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
干预措施: Engerix-BTM (Biological)
结局指标
主要结局
Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) and HPV-18
时间窗: One month after third vaccination (Month 7)
A seroconverted subject was defined as a subject seronegative at baseline whose concentration for anti-HPV-16/18 antibodies, as measured by Enzyme-linked Immunosorbent assay (ELISA) , was higher than or equal to (≥) cut-off value. A seronegative subject was defined as a subject whose antibody concentration was below (\<) cut-off value. Cut-off values were 8 ELISA 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 Seropositive Against HPV-16 and HPV-18(Before vaccination (Month 0) and one month after third vaccination (Month 7))
- Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(Within 30 days (Days 0 - 29) after any vaccination)
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms(During the 7 days (Days 0 - 6) after any vaccination)
- Number of Subjects Reporting Medically Significant Conditions (MSCs) Including Potential Immune Mediated Diseases (pIMDs)(Throughout the study (from Month 0 up to Month 12))
- Concentrations for Anti-HPV-16 and Anti-HPV-18 Antibodies(Before vaccination (Month 0) and one month after third vaccination (Month 7))
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms(During the 7 days (Days 0 - 6) after any vaccination)
- Number of Subjects Reporting Any, Grade 3 and Related Serious Adverse Events (SAEs)(Throughout the study (from Month 0 up to Month 12))
- Number of Subjects With Outcome of Pregnancies(Throughout the study (from Month 0 up to Month 12))