Evaluation of a Two-dose Schedule of Quadrivalent Human Papilloma Virus (Types 6, 11, 16, 18) Recombinant Vaccine in 11-year-old Boys in Mexico City (Gardasil® Merck and Co.).
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Immunogenicity (Geometric mean antibody concentration will be compared between the two groups)
研究概览
简要总结
In the genital tract human papilloma virus (HPV), especially types 6 and 11 cause genital warts, the commonest viral sexually transmitted disease. The HPV 16 and 18 are the most common oncogenic "high-risk" genotypes and cause approximately 70% of all cervical cancers despite the fact that are associated with other anogenital cancers, anus, vagina, vulva and penis, and cancers of the head and neck. Current estimates are that 5.2% of all cancers are HPV associated. A large number of studies, including both adult and young females, have demonstrated that HPV vaccines are highly immunogenic and induce a long lasting protection against infection. Immunogenic vaccination results in young men and boys are equally satisfactory with the quadrivalent HPV (types 6, 11, 16, 18) vaccine recommended for men. The recommended vaccination scheme includes three shots giving the second at two months and the third at six months after the initial shot. Recently, it has been shown that the use of a two shot scheme (0 and 6 months) is equally effective among girls. The purpose of this study is to determine that the immunogenicity is non-inferior in boys using a two shot scheme compared with young women and girls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 11 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All those children whose parents accept their participation in the study.
排除标准
- •previous vaccination against HPV,
- •allergy to vaccine components,
- •thrombocytopenia,
- •immunosuppression,
- •diarrhea,
- •vomiting,
- •dyscrasia,
- •administration of another anti-viral vaccine in the previous 15 days.
结局指标
主要结局
Immunogenicity (Geometric mean antibody concentration will be compared between the two groups)
时间窗: 7 months (1 month after the last dose)
Geometric means will be compared between the two groups of interest (boys and young women)
次要结局
未报告次要终点
研究者
Malaquías López Cervantes
Ph D
Universidad Nacional Autonoma de Mexico
