A Phase I/II, Double Blind, Placebo controlled, Randomized, Multicenter, prospective study to evaluate the Safety and Immunogenicity of a single dose ‘Dengue Tetravalent Vaccine, Live Attenuated (Recombinant, Lyophilized)’ in healthy subjects.
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Safety:
研究概览
简要总结
The study is a Phase I/II, Randomized,placebo-controlled, double blind, multicenter, prospective study in normalhealthy subjects. The purpose of this study is to evaluate the safety,reactogenicity, and immunogenicity of single dose of the ‘Dengue TetravalentVaccine, Live Attenuated (Recombinant, Lyophilized)’. A placebo arm is includedin the study as a control to better assess vaccine-associated versus nonvaccine-associated adverse events. It is an age de-escalation study divided intwo cohorts-Cohort 1 (≥ 18 to ≤ 60 years) and cohort 2 (≥ 02 to < 18years).There will be a DSMB meeting which will analyze the 28days post vaccination safetydata of the subjects of the first cohort and accordingly give itsrecommendations for second cohort in adolescents and children.
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
- 2.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy subjects in step wise two cohorts will be enrolled for the study: Cohort 1 subjects ≥ 18 to ≤ 60 years old Cohort 2 subjects ≥ 02 to <18 years old Subjects “With previous exposure to dengue†as well as “Without previous exposure to dengue†will be enrolled in both the Cohorts.
- •Subject in good health, based on medical history, Clinical laboratory tests and physical examination.
- •Willingness to participate throughout the study period of 3 years Inclusion criteria for females: 4.1 Female with non-child bearing potential (Females having documented history of surgical sterilization or are postmenopausal (12 months of amenorrhea after the last menstrual period) or are pre-menarche girls) 4.2 Female with child bearing potential is eligible if: -- Subject has used an effective method of contraception or abstinence from at least 4 weeks prior to vaccination AND --Subject is willing to avoid pregnancies up to 180 days post vaccination by use of an effective method of contraception or abstinence AND --Subject has negative serum pregnancy test on the screening day and negative urine pregnancy test on the day of vaccination.
排除标准
- •1.Breastfeeding woman 2.Subjects who have any clinically significant chronic disease, which, in the opinion of the investigator would endanger the volunteer’s well-being or interfere with the evaluation of the study objectives.
- •3.Known impairment of the immune function, including, but not limited to: Diabetes Mellitus, Cancer, Autoimmune diseases, asthma, Asplenia etc.
- •4.Known seropositivity for HIV, hepatitis B, and hepatitis C reported by the subject.
- •5.History of any Bleeding Disorder
- •History of severe allergic reactions or anaphylaxis.
- •History of allergy to any of the component of Investigational product.
- •Any evidence of clinically significant acute illness or infection or fever within past 3 days of study participation (Screening).
- •8.Any evidence of clinically significant.
结局指标
主要结局
Safety:
时间窗: Safety: | •Assessment of All AEs (solicited as well as Unsolicited) and SAEs occurring within 28 days post vaccination, with respect to causality, severity and frequency
•Assessment of All AEs (solicited as well as Unsolicited) and SAEs occurring within 28 days post vaccination, with respect to causality, severity and frequency
时间窗: Safety: | •Assessment of All AEs (solicited as well as Unsolicited) and SAEs occurring within 28 days post vaccination, with respect to causality, severity and frequency
次要结局
- •Determination of the serum plaque reduction neutralization titer 50% (PRNT50) to DEN1, DEN2, DEN3, and DEN4 viruses for each subject at Study Day 0, 28, and 90 post vaccination.(•Determination of the seroconversion rate (for subjects with preexisting antibodies) and seropositivity rate (for all subjects) by PRNT50 test to DENV-1, DENV-2, DENV-3, and DENV-4 viruses on Study Days 28 and 90 post vaccination)