A Long-term, Follow-up of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Novel HPV Vaccine in Healthy Female Subjects Vaccinated in the Primary Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 383
- 试验地点
- 11
- 主要终点
- Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies
研究概览
简要总结
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. GlaxoSmithKline Biological's has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also evaluating novel HPV vaccines formulations. This study will evaluate the long-term immunogenicity and safety of a novel GSK Biological's vaccine in approximately 376 subjects who received the novel vaccine or the control vaccine administered in the primary study.
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
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •A female who enrolled in the study 102115 and received three doses of vaccine.
- •Written informed consent obtained from the subject prior to enrolment.
排除标准
- •Use (or planned use during the study period) of any investigational or non-registered product or off-label use of licensed product (drug or vaccine).
- •Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.
- •Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
- •Planned administration of any HPV vaccine, other than that foreseen by the study protocol, during the study period.
结局指标
主要结局
Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies
时间窗: At Months 18, 24, 36 and 48.
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 7 EL.U/mL.
Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies.
时间窗: At Months 18, 24, 36 and 48.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 8 ELISA units per milliliter (EL.U/mL).
Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies.
时间窗: At Months 18, 24, 36 and 48.
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.
Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies
时间窗: At Months 18, 24, 36 and 48.
Antibody titers were expressed as GMTs. The reference cut-off value was greater than or equal to (≥) 8 EL.U/mL.
Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies.
时间窗: At Months 18, 24, 36 and 48.
Antibody titers were expressed as GMTs. The reference cut-off value was ≥ 7 EL.U/mL.
Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies.
时间窗: At Months 18, 24, 36 and 48.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. Seronegative subjects are subjects who had an antibody concentration below cut-off value. The assessed cut-off value was 7 EL.U/mL.
次要结局
- Number of Subjects With Pregnancy Outcomes.(From Month 0 to Month 48)
- Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies.(At Months 18, 24, 36 and 48.)
- Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies.(At Months 18, 24, 36 and 48.)
- Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies.(At Months 18, 24, 36 and 48.)
- Number of Subjects With Any Serious Adverse Events (SAEs).(From Month 0 to Months 18, 24, 36 and 48)
- Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies.(At Months 18, 24, 36 and 48.)
- Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs)(From Month 0 to Months 18, 24, 36 and 48)
- Number of Subjects With at Least One Medically Significant Condition (MAEs).(From Month 0 to Months 18, 24, 36 and 48)