Evaluation of Safety and Immunogenicity of GARDASIL™ in Healthy Females Between 9 and 26 Years of Age in SubSaharan Africa
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 250
- 主要终点
- Number of Participants Who Seroconvert to HPV Type 16
研究概览
简要总结
The study is designed to determine the safety, tolerability and immunogenicity of a 3-dose regimen of GARDASIL™ administered to healthy females between 9 and 26 years of age, in Sub-Saharan Africa. Data from the current study are needed in order to complement existing extensive safety data from the GARDASIL™ clinical trials program, and confirm that GARDASIL™ may be administered safely and will induce immune responses in populations from and living in Sub-Saharan Africa, as GARDASIL™ has not previously been studied in this region of the world.
详细描述
In Phase A of the study, healthy females between 9 and 12 years of age will be randomized (4:1) to receive the 3-dose regimen of GARDASIL™ or placebo, and those between 13 and 26 years old will receive GARDASIL™. In Phase B of the study, participants who received placebo in Phase A will have the option to receive the 3-dose regimen of GARDASIL™.
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
- 9 Years 至 26 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
GARDASIL™ 9 to 12 Years Old
GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants will not continue to study Phase B.
干预措施: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) (Biological)
GARDASIL™ 13 to 15 Years Old
GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants will not continue to study Phase B.
干预措施: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) (Biological)
GARDASIL™ 16 to 26 Years Old
GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants will not continue to study Phase B.
干预措施: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) (Biological)
Placebo 9 to 12 Years Old
Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. After database lock and unblinding for study Phase A, participants will have the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B.
干预措施: Placebo (Biological)
结局指标
主要结局
Number of Participants Who Seroconvert to HPV Type 16
时间窗: Month 7 (1 month postdose 3 in study Phase A)
Seroconversion was defined as achieving an anti-HPV Type 16 cLIA level of \>=20 milli Merck U/mL. The dilution-corrected limit of detection for the Type 16 cLIA was 9.7 milli Merck U/mL.
Number of Participants Who Seroconvert to HPV Type 11
时间窗: Month 7 (1 month postdose 3 in study Phase A)
Seroconversion was defined as achieving an anti-HPV Type 11 cLIA level of \>=16 milli Merck U/mL. The dilution-corrected limit of detection for the Type 11 cLIA was 3.9 milli Merck U/mL.
Number of Participants With Serious Adverse Experiences
时间窗: From the time of informed consent is signed through the last study visit (up to 19 months)
A serious adverse experience is any adverse experience that results in death, is life threatening, results in persistent or significant disability/incapacity, results in or prolongs existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event that may jeopardize the participant and may require medical or surgical intervention
Number of Participants Who Seroconvert to Human Papillomavirus (HPV) Type 6
时间窗: Month 7 (1 month postdose 3 in study Phase A)
Seroconversion was defined as achieving an anti-HPV Type 6 competitive Luminex Immunoassay (cLIA) level of \>=20 milli Merck U/mL. The dilution-corrected limit of detection for the Type 6 cLIA was 4.2 milli Merck U/mL.
Number of Participants Who Seroconvert to HPV Type 18
时间窗: Month 7 (1 month postdose 3 in study Phase A)
Seroconversion was defined as achieving an anti-HPV Type 18 cLIA level of \>=24 milli Merck U/mL. The dilution-corrected limit of detection for the Type 18 cLIA was 5.8 milli Merck U/mL.
Number of Participants With Injection-site Adverse Experiences
时间窗: Up to Day 5 after any vaccination in study Phase A
Participants were prompted to report injection-site experiences of pain, erythema, or swelling and were also asked to report any other injection-site adverse experiences
Number of Participants With Elevated Temperature (Oral Temperature >=100 °F)
时间窗: Up to Day 5 after any vaccination in study Phase A
次要结局
- Geometric Mean Titer (GMT) of Anti-HPV Type 6 Antibody(Month 7 (1 month postdose 3 in study Phase A))
- GMT of Anti-HPV Type 18 Antibody(Month 7 (1 month postdose 3 in study Phase A))
- GMT of Anti-HPV Type 11 Antibody(Month 7 (1 month postdose 3 in study Phase A))
- GMT of Anti-HPV Type 16 Antibody(Month 7 (1 month postdose 3 in study Phase A))