An Investigational Vaccine in Reducing the Incidence of Anogenital Warts in Young Men
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4,065
- 主要终点
- Overall Study: Incidence of HPV Type 6/11-related Genital Warts
研究概览
简要总结
This study was conducted to demonstrate that Gardasil™ (quadrivalent human papillomavirus [qHPV] vaccine) 1) is well tolerated in young men, 2) reduces incidence of external genital lesions in young men, 3) reduces the incidence of anal intraepithelial neoplasia (AIN) or anal cancer in men having sex with men (MSM), and 4) reduces incidence of Human Papillomavirus (HPV) infection in young men. In the 7-month Base Study participants received randomly assigned qHPV vaccine or placebo at Day 1, Month 2, and Month 6. Base Study follow-up continued through Month 36. In Extension 1 (EXT1), participants who received placebo or an incomplete qHPV vaccine regimen in the Base Study were offered qHPV vaccine. Participants were followed in EXT1 for 7 months. In Extension 2 [LTFU (EXT2)], long-term effectiveness, immunogenicity, and safety of qHPV vaccine were followed up to 10 years following study enrollment. Participants who received ≥1 dose of qHPV vaccine in the Base Study or EXT1 were eligible to enroll in LTFU (EXT2).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 26 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy heterosexual males between the ages of 16 years and 23 years and 364 days. Healthy men having sex with men (MSM) between the ages of 16 years and 26 years and 364 days.
- •No clinical evidence of genital lesions suggesting sexually-transmitted disease, and no history of anogenital warts
- •Additional criteria will be discussed with you by the physician
排除标准
- •Concurrently enrolled in a clinical study involving collection of genital specimens
- •History of known prior vaccination with an HPV vaccine
- •Received an inactivated vaccine within 14 days or a live virus vaccine within 21 days prior to enrollment
- •History of a severe allergic reaction that required medical intervention
- •Received any immune globulin or blood-derived products within 6 months prior to the first study injection
- •History of splenectomy, immune disorders, or receiving immunosuppressives
- •Immunocompromised or diagnosed with HIV infection
- •Known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections
- •History of recent or ongoing alcohol or drug abuse
研究组 & 干预措施
qHPV Vaccine
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6. Follow-up for the Base Study encompassed Month 7 through Month 36.
干预措施: (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (Biological)
Placebo
The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6. Follow-up for the Base Study encompassed Month 7 through Month 36.
干预措施: Comparator: placebo (unspecified) (Biological)
结局指标
主要结局
Overall Study: Incidence of HPV Type 6/11-related Genital Warts
时间窗: Up to 10 years after the first dose of qHPV vaccine
Incidence of HPV Type 6/11-related genital warts is expressed as events per 10,000 person-years of follow-up.
Base Study: Incidence of Human Papillomavirus (HPV) Type 6/11/16/18-related External Genital Warts, Penile/Perianal/Perineal Intraepithelial Neoplasia (PIN), Penile, Perianal or Perineal Cancer
时间窗: Base study: through Month 36
Participants with HPV 6/11/16/18-related external genital warts, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal or perineal cancer per 100 person-years of follow-up was assessed.
Overall Study: Incidence of HPV Type 6/11/16/18-related External Genital Warts, PIN, Penile, Perianal or Perineal Cancer
时间窗: Up to 10 years after the first dose of qHPV vaccine
Incidence of HPV Type 6/11/16/18-related external genital warts, PIN, penile, perianal or perineal cancer is expressed as events per 10,000 person-years of follow-up.
Base Study: Number of Participants With Severe Injection Site Adverse Experiences (AEs)
时间窗: Base study: through Day 5 after any vaccination
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the SPONSOR'S product, is also an adverse experience. A severe AE is incapacitating with inability to work or do usual activities.
Base Study: Number of Participants With Vaccine-Related Serious Adverse Events (SAEs)
时间窗: Base study: through Month 36
A serious adverse event is an AE that 1) results in death, 2) is life threatening, 3) results in persistent or significant disability or incapacity, 4) results in or prolongs an existing hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) based on appropriate medical judgment may jeopardize the participant and may require medical or surgical intervention. A vaccine-related AE is one deemed to be possibly, probably or definitely related to study vaccine by the investigator.
LTFU (EXT2): Number of Participants Who Died
时间窗: LTFU (EXT2): Early Vaccination Group: up to 12 years after last dose of qHPV vaccine; LTFU (EXT2) Catch-up Vaccination Group: up to 7 years after last dose of qHPV vaccine
The number of participants who died was assessed.
Overall Study: Incidence of HPV Type 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer
时间窗: Up to 10 years after the first dose of qHPV vaccine
Incidence of HPV Type 6/11/16/18-related AIN and anal cancer is expressed as events per 10,000 person-years of follow-up. MSM is men having sex with men.
LTFU (EXT2): Number of Participants With Vaccine-Related SAEs
时间窗: LTFU (EXT2): Early Vaccination Group: up to 12 years after last dose of qHPV vaccine; LTFU (EXT2) Catch-up Vaccination Group: up to 7 years after last dose of qHPV vaccine
An SAE is an AE that 1) results in death, 2) is life threatening, 3) results in persistent or significant disability or incapacity, 4) results in or prolongs an existing hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) based on appropriate medical judgment may jeopardize the participant and may require medical or surgical intervention. A vaccine-related AE is one deemed to be possibly, probably or definitely related to study vaccine by the investigator.
次要结局
- Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by cLIA(Month 120)
- Base Study: Incidence of HPV 6/11/16/18-related Deoxyribonucleic Acid (DNA) Detection(Base study: through Month 36)
- Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 7 Assessed by Competitive Luminex Immunoassay (cLIA)(Month 7)
- Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 36 Assessed by cLIA(Month 36)
- Base Study: Incidence of HPV 6/11/16/18-related Persistent Infection(Base study: through Month 36)
- Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 36 Assessed by cLIA(Month 36)
- Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 7 Assessed by cLIA(Month 7)
- Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 72 Assessed by cLIA(Month 72)
- Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 72 Assessed by cLIA(Month 72)
- Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by cLIA(Month 120)
- Geometric Mean Titers to HPV Types 6, 11, 16, and 18 at Month 120 Assessed by Immunoglobulin G Luminex Immunoassay (IgG LIA)(Month 120)
- Percentage of Participants Seropositive for HPV Type 6, 11, 16, and 18 at Month 120 Assessed by IgG LIA(Month 120)