A Phase III, Open-Label, Clinical Trial to Study the Safety and Immunogenicity of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP Particle (VLP) Vaccine in 9- to 15-Year-Old Japanese Boys
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Elevated Oral Temperature (>=37.5° C)
研究概览
简要总结
This is a study of V501 [quadrivalent Human Papillomavirus (HPV) (Type 6, 11, 16 and 18) L1 virus-like particle (VLP) vaccine] in healthy Japanese boys. This study will consist of two periods. Period I of the study is to evaluate the immunogenicity and tolerability of V501 up to Month 7. Period II of the study is to evaluate the long-term immunogenicity and safety from Month 7 to Month 30. Two analyses are planned. The first analysis will be conducted when all subjects have completed their Month 7 visit or have been discontinued before that time. The second analysis will be conducted at the end of study. The primary hypothesis tested in this study is that seroconversion rates for the vaccine HPV types will be >90% at 4 weeks postdose 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 15 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese male
- •Have a legal representative who provides written informed consent for the trial on the participant's behalf
- •Have a legal representative who is able to read, understand, and complete the vaccine report card
- •Has not yet had coitarche and does not plan on becoming sexually active from Day 1 through Month 7 of the study
- •Other inclusion criteria will be discussed with the investigator during screening
排除标准
- •Currently enrolled in clinical studies of investigational agents
- •History of known prior vaccination with an HPV vaccine or plans to receive one outside the study
- •History of severe allergic reaction that required medical intervention
- •Allergic to any vaccine component, including aluminum, yeast, or BENZONASE™
- •Received immune globulin or blood-derived products in the past 6 months or plans 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) infection, 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
- •Known thrombocytopenia or coagulation disorder that would contraindicate intramuscular injections
- •Ongoing alcohol or drug abuse within the past 12 months
- •History of genital warts or a positive test for HPV
结局指标
主要结局
Percentage of Participants With Elevated Oral Temperature (>=37.5° C)
时间窗: Up to Day 5 after any vaccination
The parent/guardian of the participant was to record the participant's oral temperature in the evening after each study vaccination and daily for 4 days after each study vaccination. Elevated temperature was defined as ≥99.5°F (≥37.5ºC). The percentage of participants that had an elevated temperature was summarized.
Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18
时间窗: Four weeks postdose 3 (Month 7)
Antibodies to HPV Types 6, 11, 16, and 18 were measured using a competitive luminex immunoassay 4 weeks after 3rd vaccination (Month 7). Antibody titers were expressed as milli Merck units/mL (mMU/mL). Seroconversion was defined as an anti-HPV 6 titer ≥20 mMU/mL, an anti-HPV 11 titer ≥16 mMU/mL, an anti-HPV 16 titer of ≥20 mMU/mL and an anti-HPV 18 titer of ≥24 mMU/mL.
Percentage of Participants With a Systemic Adverse Event
时间窗: Up to Day 15 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 parent/guardian of the participant was to record the presence of any VRC-prompted systemic AEs that occurred in the 5 days after any vaccination. The percentage of participants with a systemic AE was summarized.
Percentage of Participants With an Injection-site Adverse Event
时间窗: Up to Day 5 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 parent/guardian of the participant was to record the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 5 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (erythema, pain, and swelling) was summarized.
Percentage of Participants With a Serious Adverse Event
时间窗: Up to Day 15 after any vaccination
An AE 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. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event. The percentage of participants that experienced 1 or more SAEs was summarized.
Percentage of Participants With a Vaccine-related Serious Adverse Event
时间窗: Up to 30 months
An AE 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. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event. The percentage of participants that experienced 1 or more SAEs that were considered at least possibly related to the study vaccine was summarized.
次要结局
- Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18 Participants Aged 9 to 15 Years Versus Participants Aged 16 to 26 Years(Four weeks postdose 3 (Month 7))
- Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: Persistence at 30 Months(24 months postdose 3 (30 months))
- Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: Persistence at 18 Months(12 months postdose 3 (18 months))
- Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: Persistence at 30 Months(24 months postdose 3 (30 months))
- Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: Persistence at 18 Months(12 months postdose 3 (18 months))