A Phase III Placebo-controlled Clinical Trial to Study the Tolerability, Immunogenicity and Efficacy of V501 in 16- to 26-year-old Japanese Men
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,124
- 主要终点
- Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection
研究概览
简要总结
A study to evaluate the efficacy and tolerability of V501 (quadrivalent Human Papilloma Virus [HPV] [Type 6, 11, 16 and 18] L1 Virus-Like Particle vaccine, GARDASIL™) in healthy, 16- to 26-year old Japanese males. The hypotheses tested are: 1) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection compared with placebo, and 2) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection, condyloma acuminata, penile/perianal/perineal intraepithelial neoplasia, or penile, perianal, or perineal cancer compared with placebo.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •No clinical evidence of gross genital lesion suggesting sexually-transmitted disease and no clinically present external genital warts
- •Other inclusion criteria will be discussed with the investigator during screening
排除标准
- •History of known prior vaccination with an HPV vaccine or plans to receive one outside the study
- •History of external genital warts
- •History of severe allergic reaction that required medical intervention
- •Received immune globulin or blood-derived products in the past 6 months or plan to receive any before Month 7 of the study
- •History of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, Human Immunodeficiency Virus (HIV), lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition
- •Received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids
- •Known thrombocytopenia or coagulation disorder that would contraindicate intramuscular injections
- •Ongoing alcohol or drug abuse within the past 12 months
研究组 & 干预措施
V501
Participants received V501 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Follow-up was up to Month 36.
干预措施: V501 (Biological)
Placebo
Participants received placebo 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Follow-up was up to Month 36.
干预措施: Placebo (Biological)
结局指标
主要结局
Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection
时间窗: Up to Month 36
Persistent infection was defined as 1) polymerase chain reaction (PCR) positive to HPV Type 6, 11, 16, or 18 in 2 consecutive anogenital or biopsy samples collected ≥4 months apart, or 2) Pathology Panel consensus diagnosis of condyloma acuminate, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal, or perineal cancer and PCR detection of HPV Type 6, 11, 16, or 18 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit. The combined incidence of HPV Type 6, 11, 16, or 18 persistent infection detected in samples from ≥2 consecutive visits ≥6 months apart was assessed.
Percentage of Participants With a Vaccine-related Systemic Adverse Event
时间窗: Up to 15 days after any vaccination
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. Vaccine-related AEs are those that were deemed possibly, probably, or definitely related to vaccine administration by the investigator. The percentage of participants with a vaccine-related systemic AE was summarized.
Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card
时间窗: Up to 5 days after any vaccination
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The percentage of participants with an injection-site AE prompted on the VRC (erythema, pain, and swelling) was summarized.
Percentage of Participants With Maximum Temperature ≥37.5°C Reported on the Vaccination Report Card
时间窗: Up to 5 days after any vaccination
Body temperature (oral or oral equivalent) was recorded on the Vaccination Report Card (VRC). The percentage of participants with a maximum temperature ≥37.5°C was summarized.
Percentage of Participants With a Systemic Adverse Event
时间窗: Up to 15 days after any vaccination
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The percentage of participants with a systemic AE was summarized.
次要结局
- Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection or Disease(Up to Month 36)