An Observer-blind, Randomized, Controlled Study to Assess the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Male Subjects Aged 10-18 Years
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 6
- 主要终点
- Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18
研究概览
简要总结
The main aim of this vaccine is to prevent cervical cancer in women. However, it could also be relevant to vaccinate selected groups of males. Therefore, this study is designed to evaluate the safety and immunogenicity of the HPV vaccine in pre-teen and adolescent male subjects aged 10-18 years.
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
- 10 Years 至 18 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cervarix Group
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
干预措施: Cervarix vaccine (Biological)
Engerix-B Group
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Engerix-B™ (HBV) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule. The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
干预措施: Engerix-B vaccine (Biological)
结局指标
主要结局
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18
时间窗: At Month 7
Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies \[anti-HPV-16 titers greater than or equal to (≥) 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 titres ≥7 EL.U/mL\] in the serum of subjects seronegative before vaccination.
Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18)
时间窗: At Month 7
Titers were presented as geometric mean titers (GMT).
次要结局
- Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18(At Month 2)
- Number of Subjects With New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions(Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12))
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(Within 7 days (Days 0-6) after each dose and across doses, up to 7 months)
- Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters(At Month 2 and at Month 7, post-vaccination)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(Within 7 days (Days 0-6) after each dose and across doses, up to 7 months)
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(Within 30 days (Day 0-29) after any vaccination, up to 7 months)
- Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18)(At Month 2)
- Number of Subjects With Serious Adverse Events (SAEs)(Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12))