A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Investigate the Safety and Immunogenicity of a Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) Administered Subcutaneously to Healthy Subjects Aged 4 to 60 Years in India
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 480
- 试验地点
- 10
- 主要终点
- Safety
研究概览
简要总结
This is a phase 3, randomized, multi-site, double-blind, placebo-controlled trial in 480 healthy subjects aged ≥4 to ≤60 years living in India.
• Cohort 1: 240 subjects ≥18 to ≤60 years of age will be enrolled and randomly assigned (3:1) to receive either TDV (N=180) or placebo (N=60) at Day 1 (Month [M] 0) and Day 90 (M3).
• Cohort 2: 240 subjects ≥4 to <18 years of age will be enrolled and randomly assigned (3:1) to receive either TDV (N=180) or placebo (N=60) at Day 1 (M0) and Day 90 (M3).
Cohorts 1 and 2 will be enrolled in parallel.
Adolescents who attain the legal age of consent during or after Visit 1 (Day -28 [M -1]) will be asked to return to the investigational site to attest to the appropriate written informed consent. This may require an additional site visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects aged ≥4 to ≤60 years at the time of random assignment.
- •Male or female.
- •Subjects in good health at the time of entry into the trial.
- •Subjects and/or the subjects legally acceptable representative (LAR) who have signed and dated a written, informed consent/pediatric assent form, and any required privacy authorization prior to the initiation of any trial procedures.
- •Subjects who can comply with trial procedures and are available for the duration of follow-up.
排除标准
- •1.Subjects with any illness, or history of any illness that in the opinion of the investigator, might interfere with the results of the trial or pose an additional risk to the subject due to participation in the trial 2.Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject’s ability to participate in the trial.
- •3.BMI ≥35 kg/m2 4.Intent to participate in another clinical trial at any time during the conduct of this trial 5.Subject plans to receive any of the following (consider whether applicable as an exclusion criterion or as a criterion for delay of Visit 1): a)A licensed vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to TDV or placebo administration.
- •b)A coronavirus vaccine within 14 days prior to TDV or placebo administration.
- •c)A vaccine authorized for emergency use within 28 days of TDV or placebo administration.
- •6.Known substance or alcohol abuse within the past 2 years.
- •7.Pregnant subjects (ie, a positive or indeterminate pregnancy test) or breastfeeding.
- •8.Females of childbearing potential who are sexually active, and who: 1.have not used any of the acceptable contraceptive methods for at least 2 months prior to Day
- •2.refuse to use an acceptable contraceptive method up to 6 weeks after the last dose of TDV or placebo.
- •9.Involved in the trial conduct or their first-degree relatives.
- •10.Subjects identified as an employee of the investigator or trial center, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial center.
- •11.Receipt of previous vaccination against dengue virus.
- •12.Previous participation in any clinical trial of a dengue candidate vaccine, except if it is known that the subject received placebo while participating in those trials.
- •Exclusion Criteria at Vaccination 1.Febrile illness (body temperature ≥38°C [≥100.4°F]) or moderate or severe acute illness, or infection, at the time of random assignment 2.Medicated with antipyretic and/or analgesic medication(s) within 24 hours prior to TDV or placebo administration 3.Any new findings of illness in the interim period since screening Visit 1.
结局指标
主要结局
Safety
时间窗: Safety | 3 months apart in healthy adults, adolescents, & children | Immunogenicity | 3 months apart in healthy adults, adolescents, & children at 1 month post second dose
- To assess the safety profile of TDV administered as 2 doses given 3 months apart in healthy adults, adolescents, & children.
时间窗: Safety | 3 months apart in healthy adults, adolescents, & children | Immunogenicity | 3 months apart in healthy adults, adolescents, & children at 1 month post second dose
Immunogenicity
时间窗: Safety | 3 months apart in healthy adults, adolescents, & children | Immunogenicity | 3 months apart in healthy adults, adolescents, & children at 1 month post second dose
- To evaluate the immunogenicity of TDV administered as 2 doses given 3 months apart in healthy adults, adolescents, and children at 1 month post second dose
时间窗: Safety | 3 months apart in healthy adults, adolescents, & children | Immunogenicity | 3 months apart in healthy adults, adolescents, & children at 1 month post second dose
次要结局
- Immunogenicity(- To describe immunogenicity of TDV at baseline & 6 months post second TDV dose when administered as 2 doses given 3 months apart.)