A Phase 2, Randomized, Active-controlled, Observer-blinded Trial, To Assess The Safety, Tolerability, And Immunogenicity Of Gardasil (Registered) (Hpv) Vaccine And Bivalent Rlp2086 Vaccine When Administered Concomitantly In Healthy Subjects Aged >=11 To <18 Years
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 2,499
- 试验地点
- 165
- 主要终点
- Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens
研究概览
简要总结
This is a clinical study to assess the safety, tolerance and immunogenic response to Gardasil (human papilloma virus (HPV)) and rLP2086 vaccine. Healthy male and female subjects will be randomized into 1 of 3 groups; the trial will be an observer-blinded study to the injection being given; and, vaccinated with either Gardasil and rLP2086 concomitantly, rLP2086 and saline concomitantly, or Gardasil and saline concomitantly. The subjects are adolescent children between the ages of 11 and 17 years old.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects from 11 to 17 years old at the time of they start the study.
- •Subject must be healthy which will be determined by obtaining subject's medical history, receiving a physical examination and by judgment of the investigator.
排除标准
- •Previous vaccination with any meningococcal serogroup B vaccine.
- •Previous vaccination with any HPV vaccine.
- •Contraindication to vaccination with Gardasil or any HPV vaccine.
研究组 & 干预措施
Group 1
rLP2086 + Gardasil
干预措施: rLP2086 and Gardasil (Biological)
Group 2
rLP2086 and saline
干预措施: rLP2086 (Biological)
Group 3
Saline + Gardasil
干预措施: Gardasil (Biological)
结局指标
主要结局
Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens
时间窗: 1 month after Vaccination 3
Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24]
时间窗: 1 month after Vaccination 3
Percentage of Participants With at Least One Adverse Event (AE)
时间窗: Vaccination 1 up to 1 month after Vaccination 3
次要结局
- Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants(Before vaccination 1)
- Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)(1 month after Vaccination 3)
- Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)(Before vaccination 1, 1 month after vaccination (Vac) 2, 3)
- Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level(Before Vaccination 1, 1 month after Vaccination 2, 3)
- Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)(Before Vaccination 1, 1 month after Vaccination 2, 3)