Safety and Immunogenicity Study of an Additional Dose of HPV Vaccine (580299) in Young, Adult Women in North America.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 18
- 主要终点
- Anti-HPV-16 and Anti-HPV-18 Antibody Titers
研究概览
简要总结
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This study will further evaluate induction of immune memory and anamnestic responses in women who previously took part in the primary study (580299/001) and follow-up study (580299/007). Subjects were aged 15-25 yrs at the time of entry into the primary study and participation in the follow-up study lasted approximately 6 years. In the primary and follow-up studies, subjects were protected against HPV-16 and HPV-18 endpoints and had sustained antibody responses to both vaccine types over at least 5.5 years of follow-up. All subjects from North American study sites that completed the follow-up study will be invited to take part in the current study. The study will evaluate the safety and immunogenicity of a dose of GSK Biologicals HPV vaccine (580299) in women who had been immunologically primed 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
- 15 Years 至 25 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •A subject whom the investigator believes that she can and will comply with the requirements of the protocol
- •Must have received three doses of study vaccine or placebo control in study 580299/
- •Must have completed study 580299/
- •Written informed consent must be obtained from the subject prior to enrollment in the study.
- •Healthy subjects, as established by medical history and history-directed clinical examination before entering into the study.
- •Subject must have a negative urine pregnancy test.
- •Subject must be at least three months post-termination of a pregnancy.
- •Subject must be of non-childbearing potential,or subjects are required to be abstinent or use adequate contraceptive precautions for 30 days prior to vaccination. Subjects are also required to agree to continue such precautions for two months after completion of the vaccination series.
排除标准
- •Pregnant or breastfeeding.
- •A woman planning to become pregnant or planning to discontinue contraceptive precautions during the study until approximately 2 months after the last vaccination.
- •Use of any investigational or non-registered product 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 administration during the study period.
- •Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of each dose of vaccine. Administration of some routine vaccines up to 8 days before each dose of study vaccine is allowed.
- •Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
- •previous administration of components of the investigational vaccine outside of protocol 580299/
- •Any medically diagnosed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- •History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines,
- •Hypersensitivity to latex
- •Acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- •Cancer or autoimmune disease under treatment.
- •Administration of immunoglobulins and/or any blood products within the three months (90 days) preceding enrollment or planned administration during the study period.
- •Acute disease at the time of enrollment. All vaccines can be administered to persons with a minor illness
- •Heavy bleeding or heavy vaginal discharge in which a pelvic exam cannot be performed.
研究组 & 干预措施
Cervarix™ 4-Dose Group
Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
干预措施: Cervarix™ (Biological)
Cervarix™ 3-Dose Group
Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
干预措施: Cervarix™ (Biological)
结局指标
主要结局
Anti-HPV-16 and Anti-HPV-18 Antibody Titers
时间窗: At Day 7 and at Month 1 (Day 30)
Titers are given as geometric mean titers (GMTs) calculated on all subjects.
Number of Subjects With Anti-human Papilloma Virus-16 (Anti-HPV-16) and Anti-HPV-18 Antibody Titers Greater Than or Equal to Pre-defined Cut-off Values
时间窗: At Day 7 and Month 1 (Day 30)
Cut-off values assessed include 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 With Anti-HPV-16 and Anti-HPV-18 Greater Than or Equal to Pre-defined Cut-off Values(At Month 7 and Month 18)
- Number of Subjects Reporting Solicited Local Symptoms(Within 7 days after vaccination)
- Number of Subjects Reporting Solicited General Symptoms(Within 7 days of vaccination)
- Anti-HPV-16 and Anti-HPV-18 Antibody Titers(At Month 7 and Month 18)
- Number of Subjects With Antibody Titers Against Other Oncogenic HPV Types (HPV-31 & HPV-45) Greater Than or Equal to 59 EL.U/mL(Day 0, Month 1 (Day 30), Month 7 and Month 18)
- Number of Subjects With B Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types(Day 0, Month 1 [Day 30], Month 7 and Month 18)
- Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervico-vaginal Secretion Samples(Day 0, Month 1 (Day 30), Month 7 and Month 18)
- Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervico-vaginal Secretion Samples(Day 0, Month 1 (Day 30), Month 7 and Month 18)
- Number of Subjects Reporting Unsolicited Adverse Events (AE)(Within 30 days of vaccination)
- Outcome of Any Reported Pregnancies(From Day 0 up to Month 18)
- Number of Subjects With New Onset of Chronic Diseases (NOCDs), New Onset of Autoimmune Diseases (NOADs) and Medically Significant Conditions (MSCs)(From Day 0 up to Month 18)
- Anti-HPV-31 and Anti-HPV-45 Antibody Titers(Day 7, Month 1 (Day 30), Month 7 and Month 18)
- Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types(Day 0, Month 1 [Day 30], Month 7 and Month 18)
- Number of Subjects With Cluster of Differentiation 8 (CD8) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types(Day 0, Month 1 [Day 30], Month 7 and Month 18)
- Number of Subjects Reporting Serious Adverse Events (SAEs)(From Day 0 up to Month 18)