A Phase I/II, Open, Five-year, Clinical Follow-up Study of Thai Children Who Participated in Dengue-003 ("A Phase I/II Trial of a Tetravalent Live Attenuated DEN Vaccine in Flavivirus Antibody Naive Children") With Evaluation of a Booster Dose Given One Year After Primary DEN Vaccination Series
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
研究概览
简要总结
One year follow-up on immunogenicity and safety of a booster dose of DEN vaccine administered approx. 1 year following the second dose
详细描述
The purpose of this study is to find out more about the two doses of dengue vaccine, over a five year period, that the children received in the Dengue-003 study and to study a third dose of dengue that will be given to the children
- Do children still have dengue antibodies intended to provide protection against dengue infection one year after the two doses of vaccine given in study Dengue-003?
- Were there any major medical problems that appeared as dengue-like symptoms during the one year after vaccinations?
- Will a third dose of dengue help to further stimulate the part of the immune system intended to help protect against dengue infection?
- Is a third dose as safe as the first two doses?
- Are the local reactions to a third dose of the vaccine similar to what your child experienced after the first two doses?
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
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who received two doses of DEN vaccine in the Dengue-003 study
- •Subjects whos parents signed an informed consent form were eligible for participation in the five year follow-up study
排除标准
- 未提供
研究组 & 干预措施
Total vaccinated
The total vaccinated cohort included all enrolled subjects who received the DEN vaccine F17 for whom data were available. These subjects were Thai children previously enrolled and vaccinated in study Dengue-003
干预措施: DEN vaccine F17 (Biological)
结局指标
主要结局
Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
时间窗: Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3
Neutralizing antibodies as measured by plaque reduction neutralization test (seropositivity rates to each dengue virus serotype at Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 time points.
Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
时间窗: Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3
Neutralizing antibodies as measured by plaque reduction neutralization test (geometric mean titers \[GMTs\]) to each dengue virus serotype at Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 time points.
次要结局
- Solicited Local Adverse Events (AEs) Within 21 Day Follow-up(21 days)
- Unsolicited Adverse Events (AEs) Within 31 Days Post Vaccination(31 days)
- Serious Adverse Events (SAE) Within 31 Days Post Vaccination(31 days)
- Abnormal Findings Reported During Physical Exam 31-Days Post Vaccination(31 days)
- Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster(Prebooster year 1, 30 Days Post Booster, Year 2, Year 3)
- Presence of Dengue Viremia 10 Days After the Dengue Vaccine Dose(10 days)
- Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)(1 year, 30 Days Post Booster, 2 years)
- Subject Biochemistry and Hematology Parameters Monitored for Alert Levels(Year 1 (day 0); Year 1 (day 30); Year 2)