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Immunogenicity and Tolerability of Booster Typhoid Conjugate Vaccine (TCV) 5-6 Years After Initial Dose in Children in Burkina Faso

NCT07624175 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2026-06-03

No results posted yet for this study

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.

Conditions

  • Typhoid

Interventions

BIOLOGICAL

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

Sponsors & Collaborators

  • Groupe de Recherche Action en Sante

    collaborator OTHER

  • Kathleen Neuzil

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-17
Primary Completion
2024-10-26
Completion
2024-10-26

Countries

  • Burkina Faso

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07624175 on ClinicalTrials.gov