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Immunogenicity and Tolerability of Booster Typhoid Conjugate Vaccine (TCV) 5-6 Years After Initial Dose in Children in Burkina Faso
Sponsor: Kathleen Neuzil
Summary
This study evaluated the persistence of immunity following primary typhoid conjugate vaccination in early childhood and assessed the immunogenicity and safety of a booster dose administered 5-6 years later. Children previously enrolled in a Phase 2 randomized clinical trial of Vi-tetanus toxoid conjugate vaccine (Vi-TT) were re-enrolled at 6-7 years of age. Participants who previously received Vi-TT received a booster dose of Vi-CRM, while control participants received their first TCV dose. Anti-Vi IgG antibody responses were measured at baseline and 28 days post-vaccination. Safety was assessed through solicited and unsolicited adverse events. This study provides data on durability of TCV immunity and the potential role of booster dosing in endemic settings.
Official title: Immunogenicity and Tolerability of Typhoid Conjugate Vaccine (TCV) 5-6 Years After Routine Vaccines Administered With or Without TCV Among Children Younger Than 2 Years in Ouagadougou, Burkina Faso
Key Details
Gender
All
Age Range
6 Years - 7 Years
Study Type
INTERVENTIONAL
Enrollment
147
Start Date
2024-08-17
Completion Date
2024-10-26
Last Updated
2026-06-03
Healthy Volunteers
Yes
Conditions
Interventions
Vi capsular polysaccharide-CRM197 conjugate vaccine (Vi-CRM), 0.5 mL IM
Typhoid conjugate vaccine: Vi capsular polysaccharide conjugated to CRM197 carrier protein, administered as 0.5mL intramuscularly
Locations (1)
Schiphra Protestant Hospital
Ouagadougou, Burkina Faso