Immunogenicity and Safety of Gardasil and Twinrix Vaccines Co-administered or Administered a Month Apart, According to the 0, 6 Months Schedule and the Effect of a Third Dose of Gardasil or Cervarix Administered 42 Months Later.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 418
- 试验地点
- 2
- 主要终点
- Antibody to HPV
研究概览
简要总结
Two human papillomavirus vaccines are now commercially available.
No clinical data exist regarding:
- The immunogenicity and safety of Gardasil and Twinrix when co-administered.
- The immunogenicity and safety of Cervarix when administered to subjects previously vaccinated with Gardasil.
The main objective of the first phase of this clinical trial was:
• To assess and compare the immunogenicity of Gardasil and Twinrix Junior when co-administered or administered at one month interval according to a 0, 6 month schedule to 9-10 year-old girls.
The main objective of the seconde phase of this clinical trial is:
• To determine the effect of a booster dose of Gardasil or Cervarix on HPV antibodies when given 42 months post-vaccination of 9-10 year-old girls with two doses of Gardasil.
Study Design & Duration:
Experimental Design: Blind for the third HPV vaccine dose, randomized, single centre study with two treatment groups.
Duration of the study:
Participants will be followed for the duration of 10 years post-primary vaccination.
Number of Centres:
One Center.
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
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 14 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •In 2008-2009 received two doses of Gardasil at the age of 9-10 years according to 0, 6 months schedule.
排除标准
- •Received less than two doses of Gardasil or received an HPV vaccine outside the study protocol.
结局指标
主要结局
Antibody to HPV
时间窗: 1 month post booster dose
The effect of a booster dose of Gardasil or Cervarix administered randomly (1:1) to subjects vaccinated 42 months before with two doses of Gardasil.
次要结局
- Safety of a booster dose of Gardasil and Cervarix administered 42 months after the second dose of Gardasil.(Solicited adverse events 5 days post vaccine administration. Serious adverse events during the study period.)
研究者
Vladimir Gilca
Principal investigator
Laval University