A Phase 3, Single-Center, Open-label, Controlled, Randomized Study to Evaluate the Safety and Immunogenicity of Novartis Men ACWY Vaccine Administered Either Alone or Concomitantly With a Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine and Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine in Healthy Adolescents
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,620
- 试验地点
- 2
- 主要终点
- Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse
研究概览
简要总结
This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with Tdap and HPV vaccinations to healthy adolescents
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
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adolescents 11-18 years of age
- •virgins (both male and female) with no intention of becoming sexually active during the study period
- •who have been properly vaccinated against diphtheria, tetanus, pertussis
排除标准
- •who had a previous confirmed or suspected disease caused by N. meningitidis;
- •who have previously been immunized with a meningococcal vaccine
- •who have received prior human papillomavirus (HPV) vaccine;
- •who have any serious acute, chronic or progressive disease
- •who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome;
- •who have a known or suspected impairment/alteration of immune function, either congenital or acquired
- •who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
- •who have Down's syndrome or other known cytogenic disorders;
结局指标
主要结局
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse
时间窗: 1 month post MenACWY vaccination
Immune responses to MenACWY, as measured by the percentage of hSBA seroresponders, when given: (a) alone; (b) concomitantly with a Tetanus diphtheria acellular pertussis (Tdap) vaccine and a Human Papillomavirus Recombinant (HPV) vaccine; and (c) when given one month after a Tdap vaccine. Seroresponse to MenACWY: For a subject with baseline hSBA titer \<1:4, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with baseline hSBA titer ≥ 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL
时间窗: 1 month post Tdap vaccination
To compare the immune response to Tdap given concomitantly with MenACWY and HPV vaccine with the immune response to Tdap when administered alone
Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN)
时间窗: 1 month post Tdap vaccination
To compare the immune response of Tdap given concomitantly with MenACWY and HPV vaccine with the immune response of Tdap when administered alone
次要结局
- Effect of Concomitant and Sequential Vaccination on hSBA Geometric Mean Titers (GMTs) for A, C, W, and Y Serogroups(1 month post MenACWY vaccination)
- Percentage of Subjects With Anti-HPV Seroconversion(1 month post third HPV vaccination)
- The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus(1 month post Tdap vaccination)
- Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus(1 month post Tdap vaccination)
- Geometric Mean Titers (GMT) of Pertussis Antigens(1 month post Tdap vaccination)
- Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN(1 month post Tdap vaccination)
- Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups(1 month post MenACWY vaccination)
- Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay(1 month post third HPV vaccination)
- Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.(Days 1 to 7)
- Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination(Days 1 to 7)