The Association Between Prior Exposure to Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) and Dengue Hospitalization in a Pediatric and Adolescent Population: A Nested Case-Control Post-Authorization Effectiveness Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70,000
- 试验地点
- 7
- 主要终点
- Hospitalization Due to VCD of Any Dengue Serotype in Unvaccinated and Fully Vaccinated Participants
研究概览
简要总结
The main aim of this study is to collect more information on the effectiveness of TDV when used in a pilot public vaccination program for children and adolescents participating in a community-based cohort in Southeast Asian countries with high dengue transmission, specifically Thailand, Indonesia, and Malaysia where TDV is already approved for use.
The study will include cohort participants (individual follow-up of 3 years) who may or may not later be vaccinated with TDV as part of a pilot public vaccination program in the study countries. The study will investigate if cohort participants who were vaccinated with TDV have less hospital stays due to dengue than cohort participants who were not vaccinated with TDV. The study will also provide further information on the effectiveness of TDV against the least common dengue virus serotypes (DENV-3 and DENV-4).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be eligible for inclusion in the study cohort, participants must meet the following inclusion criteria:
- •The participant is a child or adolescent eligible to be vaccinated with TDV as part of a vaccination program planned in the study area.
- •The participant's family do not intend to migrate away from the cohort hospital catchment area within 3 years of his/her enrollment into the study cohort.
- •The participant's parent(s) or legally acceptable representative (LAR) signs and dates a written informed consent form (ICF), and any required privacy authorization where applicable, prior to the initiation of any study procedures, after the nature of the study has been explained according to local regulatory requirements.
- •The participant signs and dates an age-appropriate assent form prior to the initiation of any study procedures, after the nature of the study has been explained according to local regulatory requirements.
- •The participant's parent(s) or LAR agrees that a baseline blood sample may be taken from the participant.
- •To be eligible for inclusion as a case, participants must meet the following inclusion criteria:
- •The participant is part of the cohort.
- •The participant is hospitalized and clinically diagnosed with dengue.
- •The participant has a blood sample available that was taken preferably within 5 days of fever onset and/or onset of symptoms compatible with dengue.
- •The participant tested positive for dengue by RT-PCR.
- •To be eligible for inclusion as a matched control, participants must meet the following inclusion criteria:
- •The participant is part of the cohort.
- •The participant had not been hospitalized with VCD at any point between enrollment in the cohort and the index date (that is, when his/her matched case was hospitalized with CDD).
- •The participant is a resident in the same neighbourhood as the matched case.
- •The participant's date of birth is in the same calendar year as the matched case.
排除标准
- •To be eligible for inclusion as a case participants must not meet any of the following criteria:
- •The participant has been vaccinated with TDV, a tetravalent, live attenuated, chimeric dengue vaccine in a yellow fever 17D backbone (CYD-TDV), or an investigational dengue vaccine prior to cohort enrollment.
- •Contraindications as per the locally approved label/product information leaflet.
- •To be eligible for inclusion as a control participants must not meet any of the following criteria:
- •The participant has been vaccinated with TDV, CYD-TDV, or an investigational dengue vaccine prior to cohort enrollment.
- •Contraindications as per the locally approved label/product information leaflet.
- •The participant could not be contacted at the time of being selected as a control.
研究组 & 干预措施
Nested Case-control Participants
The cohort will include case and control participants. Case participants who are hospitalized and meet the study inclusion and exclusion criteria for cases, have CDD, and have a confirmed positive RT-PCR test result (VCD) will be ascertained by active hospital surveillance.
Control participants who are matched to a case and meet the study inclusion and exclusion criteria for controls but have not been hospitalized with VCD on or before their case's index date (first date of hospitalization for CDD for potential cases) will be interviewed.
干预措施: No Intervention (Other)
结局指标
主要结局
Hospitalization Due to VCD of Any Dengue Serotype in Unvaccinated and Fully Vaccinated Participants
时间窗: Up to Month 36
Number of participants hospitalized due to VCD of any dengue serotype in unvaccinated and fully vaccinated participants.
次要结局
- Hospitalization Due to VCD By Each Infecting Dengue Serotype (DENV-1, DENV-2, DENV-3, DENV-4) in Unvaccinated and Fully Vaccinated Participants(Up to Month 36)
- Hospitalization Due to VCD by Baseline Dengue Serostatus (Seronegative and Seropositive) of Any Dengue Serotype in Unvaccinated and Fully Vaccinated Participants(Up to Month 36)
- Hospitalization Due to VCD By Each Infecting Dengue Serotype and Baseline Dengue Serostatus in Unvaccinated and Fully Vaccinated Participants(Up to Month 36)