Evaluation of Typhoid Conjugate Vaccine (TCV) Effectiveness Among Bangladeshi Children Using the Test-negative Design
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Primary outcome
研究概览
简要总结
This is a prospective closed cohort, open-label, phase III effectiveness study using a test-negative design of a typhoid conjugate vaccine, ZyVac® TCV (purified Vi capsular polysaccharide of Salmonella Typhi conjugated to tetanus toxoid as carrier protein), manufactured by Zydus Lifesciences Limited. The study will be conducted in a closed cohort population among children aged 6 months to 15 years residing in wards 5, 6, 7, 48, 49, 50, 63, 71, and 72 of Dhaka South City Corporation (DSCC). The targeted number of age-eligible children in the study area is ~92,000 among them ~60,000 will be vaccinated. A subset of the first 600 consenting participants will be selected by age strata (6 months to <2 years, 2-4 years, 5-15 years) for enrollment in the immunogenicity study with an additional three follow-up visits. Diary cards will be used to collect adverse events (AEs) following immunization (AEFI) data up to day 7 for a subset of active follow-up of the first 600 vaccinated participants. Participants not in this subset will be encouraged to go to the 'Adverse Event Monitoring Cell' at the Maniknagar field office. Data on serious adverse events (SAEs) will be reported for six months after vaccination. All study updates including AEs and SAEs will be reported to the data safety and monitoring board (DSMB) and sponsor. Passive surveillance for typhoid fever will be carried out in the Maniknagar field office and Mugda Medical College and Hospital in the catchment area among the age-eligible children.
详细描述
This will be a phase III effectiveness study of the typhoid conjugate vaccine (Vi-TCV) (ZyVac® TCV). The study will be conducted in a closed cohort population of children aged 6 months to 15 years residing in a selected geographical catchment area in Dhaka, Bangladesh using a test-negative design (TND). The TND is a particular type of case-control study including controls who present themselves with similar signs and symptoms (to those of the cases) in the same healthcare facilities. Individuals with the disease of interest are tested with a laboratory assay where test-positive and test-negative individuals are considered cases and controls, respectively.
Hypothesis:
The typhoid Vi-polysaccharide conjugate vaccine will be effective in preventing typhoid fever among Bangladeshi children.
Specific Objectives
Primary objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant was included in the baseline list of the study population
- •Participants living within the study catchment area at the time of vaccination
- •Parent/guardian is willing and competent to provide informed consent (if the participant is 11 to 15 years of age, assent will also be sought)
- •Participants aged between 6 months to15 years (i.e. up to 15 years 364 days) at the time of vaccination
- •Apparently healthy (no complaints of febrile illness) on the day of vaccination
- •Parent/guardian confirms that their child will be willing and be able to comply with study requirements
排除标准
- •Has knowingly received a typhoid vaccine in the past
- •Known allergy to any vaccine in the past
- •Medical or social reasons that will prevent the participant from conforming to the study requirements as judged by a medical professional
- •Planning to move away from the catchment area within the next 12 months
- •Pregnant at the time of vaccination, as confirmed by a urine test (urine pregnancy test will be done in girls who are married)
- •Confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy
- •Subject participated in another clinical study in the past 3 months
结局指标
主要结局
Primary outcome
时间窗: 12 months
Blood culture-confirmed typhoid fever
次要结局
- Secondary outcome(12 months)