A Phase 3 International, Multicenter, Open-label Study to Evaluate the Safety and Immunogenicity of 9vHPV Vaccine Administered as 2-dose Regimen With Extended Dosing Intervals in 9- to 14-Year Old Boys and Girls Compared With a Standard 3-dose Regimen in 16- to 26-Year Old Women
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 700
- 试验地点
- 30
- 主要终点
- Geometric Mean Titers of Anti-Human Papilloma Virus Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 as Measured by Competitive Luminex Immunoassay
研究概览
简要总结
This is a 96-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in young women 16 to 26 years of age. From this study, the goal is to establish that the investigational extended 2-dose regimens (0, 12 months; 0, 24 months; 0, 36 months; and 0, 60 months) studied in boys and girls 9 to 14 years of age are generally safe and immunogenic, with an antibody response that is not inferior to that observed in young women 16 to 26 years of age who receive the standard 3-dose regimen of 9-valent human papillomavirus (9vHPV) vaccine at 0, 2, and 6 months (i.e., the population and dose regimen used to establish 9vHPV vaccine efficacy).
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
- None
入排标准
- 年龄范围
- 9 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Boys and Girls 9 to 15 Years:
- •Must not have had coitarche and does not plan on becoming sexually active during the vaccination period
- •Women 16 to 26 Years:
- •Has never had a Papanicolaou (Pap) test or only had normal Pap test results
- •A lifetime history of 0 to 4 male and/or female sexual partners
- •Cohort 0 Participants:
- •Received 1 dose of 9vHPV vaccine at least 1 year prior to enrollment and did not receive a second dose of any HPV vaccine
排除标准
- •All Participants:
- •Known allergy to any vaccine component
- •History of severe allergic reaction that required medical intervention
- •Thrombocytopenia or any coagulation disorder
- •Females only: participant is pregnant or expecting to donate eggs during day 1 through month 7
- •Currently immunocompromised, or been diagnosed with immunodeficiency
- •Had a splenectomy
- •Receiving or has received immunosuppressive therapies within the last year
- •Received any immunoglobulin product or blood-derived product within 3 months
- •Has received more than 1 dose of an HPV vaccine (Cohort 0)
- •Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial (Cohorts 1-5)
研究组 & 干预措施
Cohort 0: 1 Dose of 9vHPV Vaccine (previous 1-dose recipients)
10 to 15 year old girls and boys (who previously received 1 dose of 9vHPV vaccine) receive a second dose of 9vHPV vaccine at Day 1.
干预措施: 9vHPV vaccine (Biological)
Cohort 1: 2 Doses of 9vHPV Vaccine Given 12 Months Apart
9 to 14 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 12.
干预措施: 9vHPV vaccine (Biological)
Cohort 2: 2 Doses of 9vHPV Vaccine Given 24 Months Apart
9 to 13 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Months 24.
干预措施: 9vHPV vaccine (Biological)
Cohort 3: 2 Doses of 9vHPV Vaccine Given 36 Months Apart
9 to 12 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 36.
干预措施: 9vHPV vaccine (Biological)
Cohort 4: 2 Doses of 9vHPV Vaccine Given 60 Months Apart
9 to 10 year old girls and boys receive a 2-dose regimen of 9vHPV vaccine at Day 1 and Month 60.
干预措施: 9vHPV vaccine (Biological)
Cohort 5: 3 Doses of 9vHPV Vaccine Given Over a 6-Month Period
16 to 26 year old young women receive 3 dose regimen of 9vHPV vaccine at 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 of Anti-Human Papilloma Virus Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 as Measured by Competitive Luminex Immunoassay
时间窗: 4 weeks post last vaccination (Up to ~Month 61)
Serum antibody titers for human papilloma virus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 will be determined using competitive luminex immunoassay (cLIA). The geometric mean titer (GMT) for each HPV type will be reported in milli Merck units/mL (mMU/mL).
Percentage of Participants With at Least 1 Serious Vaccine-Related Adverse Event
时间窗: Entire study period (Up to ~Month 96)
A serious adverse event (SAE) is defined as one that results in death, is life threatening, or requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or other important medical event that may require medical intervention. An SAE that is judged by the investigator to be related to the study vaccine is defined as a vaccine-related SAE.
Percentage of Participants With at Least 1 Systemic Adverse Event
时间窗: Up to 15 days post vaccination
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with a systemic AE will be assessed.
Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event
时间窗: Up to 5 days post vaccination
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with injection-site AEs (erythema/redness, pain and swelling) will be assessed.
次要结局
- Percentage of Participants (Cohorts 1 to 5) Who Are Seropositive for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58(36 months post last vaccination)
- Geometric Mean Titers ( Cohorts 1 to 5) of Anti HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58(24 months post last vaccination)
- Geometric Mean Titers ( Cohorts 1 to 5) of Anti HPV Types 6, 11, 16, 18, 31, 33, 45, 52 , and 58(36 months post last vaccination)
- Geometric Mean Titers (Cohorts 1 to 5) of Anti HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58(12 months post last vaccination)