A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of 9vHPV (V503), a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, in 16- to 26-Year-Old Men and 16- to 26-Year-Old Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,520
- 主要终点
- Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine
研究概览
简要总结
This study is designed to evaluate the immunogenicity and tolerability of 9vHPV (9-valent HPV vaccine, V503) in 16- to 26-year old men and women. The overall goal is to bridge 9vHPV efficacy findings in young women to young men based on the demonstration of similar immunogenicity and safety profiles. The primary hypothesis is that 9vHPV induces antibody responses at 4 weeks postdose 3 in heterosexual males that are non-inferior to antibody responses in young women.
详细描述
Study participants will be administered a 3-dose regimen of 9vHPV. They will be assessed for immunogenicity 1 month following completion of vaccination. All participants will be followed for safety for a total of 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good physical health
- •Has never had Papanicolaou testing (Pap, cervical or anal) or has only had normal Pap test results
- •Other inclusion criteria will be discussed with the investigator
排除标准
- •History of severe allergic reaction that required medical intervention
- •Currently enrolled in a clinical trial
- •If participant is female, pregnant
- •Currently immunocompromised or having received immunosuppressive therapy in the last year
- •Positive test for HPV
- •History of HPV-related external genital lesions or HPV-related anal lesions or anal cancer
- •If participant is female, history of abnormal cervical biopsy results
- •Other exclusion criteria will be discussed with the investigator
研究组 & 干预措施
Females
Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
干预措施: 9vHPV Vaccine (Biological)
Heterosexual Males
Healthy heterosexual males 16 to 26 years of age received 9vHPV 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
干预措施: 9vHPV Vaccine (Biological)
Men who have Sex with Men
Healthy MSM 16 to 26 years of age received 9vHPV 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
干预措施: 9vHPV Vaccine (Biological)
结局指标
主要结局
Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine
时间窗: Four weeks post vaccination 3 (Month 7)
Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL
Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card
时间窗: Up to 5 days after any vaccination
An adverse experience (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 study vaccine, 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 study vaccine is also an AE. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, and swelling. Participants were instructed to use the Vaccination Report Card to record AEs daily after each study vaccination.
Percentage of Participants With Elevated Oral Body Temperature (>=37.8° C, >=100° F)
时间窗: Up to 5 days after any vaccination
Participants were instructed by the investigator to use the Vaccination Report Card to document evening oral temperature daily after each study vaccination
Percentage of Participants With an Adverse Event
时间窗: Up to Month 12
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 study vaccine, 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 study vaccine is also an AE.
Percentage of Participants Who Had Study Vaccine Discontinued Due to an Adverse Event
时间窗: Up to Month 12
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 study vaccine, 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 study vaccine is also an AE.
次要结局
- Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine(Four weeks post vaccination 3 (Month 7))