ZyVac-TCV Bangladesh Study (NCT06757283) | Clinical Trial Compass
Not Yet RecruitingPhase 3
ZyVac-TCV Bangladesh Study
Bangladesh4,000 participantsStarted 2025-04-01
Plain-language summary
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.
Who can participate
Age range
6 Months – 15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary outcome
Timeframe: 12 months
Trial details
NCT IDNCT06757283
SponsorInternational Centre for Diarrhoeal Disease Research, Bangladesh