ISRCTN11643110进行中（未招募）4 期
Assessing the impact of a Vi-Polysaccharide Conjugate Vaccine in preventing typhoid infection among Bangladeshi children – a Phase IV trial
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 32,500
研究概览
简要总结
2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/30845333/ protocol (added 29/05/2020) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37090439/ (added 24/04/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Parent/guardian is willing and competent to provide informed consent. If the participant is 11 to <16 years of age, informed assent will also be sought
- •2. Aged between 9 months (or eligible for measles vaccination according to local protocol) and <16 years (i.e. up to 15 years 364 days) at time of vaccination
- •3. Apparently healthy (no complaints of febrile illness) on the day of vaccination
- •4. Parent/guardian confirms that their child will be willing and be able to comply with study requirements including follow-up contact, according the schedule (Appendix B)
- •5. Living within the study catchment area at the time of vaccination
排除标准
- •Current participant exclusion criteria as of 13/08/2018:
- •1. Has knowingly received a typhoid or Japanese encephalitis vaccine in the last three years
- •2. Known allergy to any of the vaccine components
- •3. Medical or social reasons that will prevent the participant from conforming to the study requirements as judged by a medical professional
- •4. Planning to move away from the catchment area within the next month
- •5. Pregnant at the time of vaccination, as confirmed by a urine test (urine pregnancy test will be done in girls who are married)
- •Temporary exclusion criteria:
- •1. Receipt of any other vaccines in the last 30 days
- •2. Current temperature of at least 38°C or reported fever within 24 hours prior to vaccination
- •3. Use of antipyretics within 4 hours prior to vaccination
- •4. Unmarried girls between the ages of =12 and <16 years old whose first day of their last menstrual period (LMP) is more than 28 days ago or who do not know the date they last menstruated upon presentation
- •Previous participant exclusion criteria:
- •1. Has knowingly received a typhoid or Japanese encephalitis vaccine in the last three years
- •2. Known allergy to any of the vaccine components
- •3. Medical or social reasons that will prevent the participant from conforming to the study requirements as judged by a medical professional
- •4. Planning to move away from the catchment area within the next month
- •5. Pregnant at the time of vaccination, as confirmed by a urine test (urine pregnancy test will be done in girls who are married)
研究者
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