Surveillance of Suspected Dengue Cases for Access to Care for Subjects Identified as Seronegative or Undetermined at Baseline and Who Received CYD Dengue Vaccine in CYD15, CYD13, CYD29, CYD64, CYD65 Trials in Colombia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 918
- 试验地点
- 1
- 主要终点
- Virologically-confirmed dengue cases
研究概览
简要总结
The primary objective of the study is to identify any suspected dengue case in subjects that received at least one dose of the CYD dengue vaccine who were classified as seronegative or undetermined at baseline (according to PRNT50 at baseline, or anti-non-structural protein 1 [NS1] test Post-dose 3) in the Colombian study sites of CYD15, CYD13, CYD29, CYD64, CYD65 trials in order to allow appropriate access to care until the completion of 10 years after the last CYD Dengue Vaccine received by each participant
详细描述
The planned duration of each participant's participation in the study will vary according to the date when they received their last CYD Dengue Vaccine. The surveillance will last during 10 year after the last CYD dengue vaccination of included participants
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants classified as seronegative or undetermined at baseline (by PRNT50 at baseline or anti-NS1 test Post-dose 3) that had received at least one dose of the tetravalent CYD dengue vaccine in the clinical sites of CYD15, CYD13, CYD29, CYD64, or CYD65 studies in Colombia
- •Informed consent form or Assent form has been signed and dated by the participant (based on local regulations), and/or informed consent form has been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations)
- •Participant (or participant and parent[s] or another legally acceptable representative) is (are) able to comply with all study procedures
- •Exclusion criteria:
- •Participants that were withdrawn from the CYD15, CYD13, CYD29, CYD64, or CYD65 study in Colombia study due to "lost to follow-up" and despite various attempts, were not possible to be contacted
- •Participants that cannot be contacted after 3 phone calls, SMS, one home visit and written contact letter/email/WhatsApp
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
排除标准
- 未提供
结局指标
主要结局
Virologically-confirmed dengue cases
时间窗: From Day 0 to end of participation (10 years after last dengue vaccination)
Dengue disease confirmed by NS1 Rapid Diagnostic Test in participant with suspected dengue
Type of access to care provided for participant with confirmed dengue
时间窗: From Day 0 to end of participation (10 years after last dengue vaccination)
Types of access are: urgent care/emergency room visit, hospitalization, medical care for suspected dengue case until dengue confirmation, diagnostic procedures and treatment, and medication
Suspected dengue case as per clinical diagnosis
时间窗: From Day 0 to end of participation (10 years after last dengue vaccination)
Suspected dengue is defined by high fever (40°C / 140 °F) and at least two of the following: nausea/vomiting, rash, aches and pain, tourniquet test positive, leukopenia, any warning sign
次要结局
未报告次要终点