NCT01335412已完成不适用
Active Surveillance for Adverse Events After Immunization With IXIARO(R) Among U.S. Military Service Personnel
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- Incidence of pre-defined, serious adverse events
研究概览
简要总结
This is an active electronic surveillance using data from the Defense Medical Surveillance System (DMSS) to detect and characterize serious, rare adverse events occurring within 42 days after vaccination with the Japanese Encephalitis Vaccine IXIARO within the US Military, to detect adverse events that occur more frequently after IXIARO and to electronically follow up pregnancies during or shortly before which IXIARO was administered.
There will be no intervention and no individuals contacted.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female active duty U.S. military personnel ≥ 17 years of age who either received at least one dose of IXIARO (IXIARO exposed group) or at least one dose of JE-VAX (comparison group).
排除标准
- •Individuals who have an ICD-9-CM code suggestive of one of the predefined adverse events screened for in IC51-401 prior to vaccination with IXIARO cannot with certainty be classified as being "disease free" at study entry and will be excluded for that adverse event.
结局指标
主要结局
Incidence of pre-defined, serious adverse events
时间窗: 42 days after each dose of IXIARO
次要结局
- Detection of non-predefined Adverse Events overrepresented after IXIARO(42 days after each dose of IXIARO)
- Occurrence of complications during pregnancy(Up to delivery)
- Occurrance of infant health complications(up to 3 months after birth)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Participant Centered Active Surveillance for Adverse Event Following Measles Immunization in Gedeo Zone, Ethiopia, 2022. A Multi-center Open-label Randomized Control TrialMeaslesNCT05803538Dilla University391
已完成
不适用
Active Surveillance for Adverse Events Following Immunization With the Influenza Vaccine Produced at Butantan InstituteInfluenza VaccinesNCT03057483Butantan Institute533
进行中（未招募）
不适用
A Study to Monitor the Adverse Events of QDENGA Vaccine in Participants in MalaysiaDengue FeverNCT06388785Takeda2,000
已完成
不适用
Active Surveillance for Adverse Events Following Immunization With the Butantan Trivalent Influenza Vaccine (2018)Influenza, HumanOrthomyxoviridae InfectionsRNA Virus InfectionsRespiratory Tract InfectionsVirus DiseasesVaccinesPhysiological Effects of DrugsNCT03392207Butantan Institute403
已完成
不适用
EXploring Immune-related Adverse Events of Immune checkpoinT Inhibitors Using VigiBase, the WHO Pharmacovigilance DatabaseImmune-related Adverse EventImmune Checkpoint Inhibitor-Related MyocarditisCancerNCT05934214Groupe Hospitalier Pitie-Salpetriere141,630