ZyVac-TCV Bangladesh Study

Launched by INTERNATIONAL CENTRE FOR DIARRHOEAL DISEASE RESEARCH, BANGLADESH · Dec 31, 2024

Keywords

ClinConnect Summary

The ZyVac-TCV Bangladesh Study is a clinical trial aimed at testing a new typhoid vaccine called ZyVac® TCV. This study will focus on children aged 6 months to 15 years living in specific areas of Dhaka, Bangladesh. About 60,000 children will be vaccinated, and researchers want to see how effective this vaccine is in preventing typhoid fever, a serious illness caused by bacteria. The study will also monitor any side effects from the vaccine and follow up with some participants to gather more information.

To be eligible for the study, children must be healthy, live in the study area, and have not received a typhoid vaccine before. Parents or guardians must give their permission for their children to participate. Those who join the study can expect to receive the vaccine and will have follow-up visits to check on their health and any possible side effects. This trial is important because it aims to improve vaccination strategies against typhoid fever, which affects many children in Bangladesh.

Gender

ALL

Eligibility criteria

• 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