NCT01304498已完成3 期
A Randomized, Double-Blinded, Controlled With GARDASIL (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, Adsorbed)), Phase III Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus (HPV) Vaccine) in Preadolescent and Adolescent Girls (9- to 15-year-old)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 600
- 主要终点
- Geometric Mean Titers (GMTs) to HPV Types 16 and 18
研究概览
简要总结
Primary objective:
• To demonstrate that administration of V503 induces non-inferior Geometric Mean Titers (GMTs) (for serum anti-HPV16 and anti-HPV18) compared to GARDASIL.
Secondary objectives:
- To evaluate the tolerability of V503 in 9-15 year-old girls.
- To summarize humoral immune response (anti-HPV 6, 11, 16, 18) induced by V503 or 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 15 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female from 9 to 15 years old.
- •Good physical health.
排除标准
- •Known allergy to any vaccine component.
- •History of severe allergic reaction.
- •Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
- •Pregnant subject.
- •Immunocompromised or immunodeficient subject.
- •Splenectomy.
- •Receipt of medication / vaccine that may interfere with study assessment.
- •History of a positive test for HPV, prior receipt of HPV vaccine or prior participation to HPV trial.
- •Any condition that might interfere with study assessment.
研究组 & 干预措施
GARDASIL
Active Comparator
Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
干预措施: GARDASIL (Biological)
V503
Experimental
9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6
干预措施: V503 (Biological)
结局指标
主要结局
Geometric Mean Titers (GMTs) to HPV Types 16 and 18
时间窗: 4 weeks postdose 3 (Month 7)
Serum antibodies to HPV types 16 and 18 were measured with a Competitive Luminex Immunoassay.
次要结局
- GMTs to HPV Types 6 and 11(4 weeks postdose 3 (Month 7))
- Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18(4 weeks postdose 3 (Month 7))
- Percentage of Participants With One or More Adverse Events(Up to Month 7)
- Percentage of Participants With One or More Injection-site Adverse Reactions(Up to 5 days after any vaccination)
- Percentage of Participants With One or More Systemic Adverse Events(Up to 15 days after any vaccination)
- Percentage of Participants With Maximum Oral Temperature ≥37.8°C(Up to 15 days after any vaccination)
- Percentage of Participants With One or More Serious Adverse Events(Up to Month 7)
研究者
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