Typhoid Conjugate Vaccine Trial Among Children Younger Than 2 Years in Ouagadougou, Burkina Faso (NCT03614533) | Clinical Trial Compass
CompletedPhase 2
Typhoid Conjugate Vaccine Trial Among Children Younger Than 2 Years in Ouagadougou, Burkina Faso
Burkina Faso251 participantsStarted 2018-12-03
Plain-language summary
Typhoid fever is an illness that may cause mild effects in children, such as fever and feeling tired, or it may cause serious effects-- even death. A new typhoid vaccine has recently been recommended by the World Health Organization (WHO) to prevent typhoid in children. But this new typhoid vaccine has not been tested with all of the vaccines given to children in Burkina Faso. The investigators want to look at this new vaccine, and study how safe it is in children in Burkina Faso and how their immune systems respond to the vaccine when given with other vaccines, such as yellow fever and meningitis A vaccines.
The investigators plan to vaccinate 100 children between the ages of 9-11 months, and 150 children between the ages of 15 months and 2 years, in Ouagadougou, Burkina Faso, with either the typhoid vaccine or a vaccine against another illness called polio.
Children will have follow-up visits on days 3, 7, 28 and 180. One teaspoon of blood will be collected on days 0 and 28.
Who can participate
Age range
9 Months – 23 Months
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: Each subject receiving study vaccine (Vi-TCV or IPV) must satisfy the following inclusion criteria at study entry:
* Male or female child 9 through11 months of age for cohort 1, or 15 months through 23 months of age for cohort 2, and in good health at the time of study vaccination.
* A child whose parent or guardian resides primarily within the study area at the time of study vaccinations and who intends to be present in the area for the duration of the trial.
* A child whose parent or guardian has voluntarily given informed consent.
Exclusion Criteria: No subject receiving study vaccine (Vi-TCV or IPV) may have any of the following exclusion criteria at study entry:
* History of documented hypersensitivity to any component of the vaccine.
* Prior receipt of any typhoid vaccine.
* History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis.
* Known history of diabetes, tuberculosis, cancer, chronic kidney, heart, or liver disease, progressive neurological disorders, poorly controlled seizures, or terminal illness.
* Severe malnutrition as determined by a MUAC \< 12.5 cm.
* Receipt of any other investigational intervention in the last 6 months or anticipated during the course of the study.
* Receipt of blood products in the last 6 months.
* Known HIV infection or exposure or other immunosuppressive conditions.
* Receipt of systemic immunosuppressant or systemic corticosteroids.
* Receipt of any measles-rubella-containing va…
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.