NCT07930988 Typhoid Conjugate Vaccine Introduction in Madagascar (TyMA): Evaluation of the Real-World Effectiveness of the Vi-CRM197 Typhoid Conjugate Vaccine in Madagascar
| NCT ID | NCT07930988 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Rita Soares Barbosa Cardona |
| Condition | Salmonella Typhi Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 60,000 participants |
| Start Date | 2023-07-23 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60,000 participants in total. It began in 2023-07-23 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study evaluates the real-world effectiveness, safety, and immunogenicity of a single dose of the Vi-CRM197 typhoid conjugate vaccine (TCV) delivered through a mass vaccination campaign in selected districts of Madagascar. The study targets individuals aged 9 months to 45 years living in defined catchment areas with a high burden of typhoid fever. The project integrates three components: a population census with geographic mapping, a vaccination campaign using a WHO-prequalified Vi-CRM197 TCV, and prospective surveillance for typhoid fever. Vaccine effectiveness will be assessed by comparing the incidence of blood culture-confirmed Salmonella Typhi infection among vaccinated and unvaccinated individuals during follow-up. Additional outcomes include clinically suspected typhoid fever, severe disease, vaccine safety, immunogenicity, antibiotic use and consumption, and carriage of antimicrobial resistance (AMR) markers. The study aims to generate real-world evidence to inform public health decision-making regarding typhoid vaccine introduction and its broader impact on disease burden and antimicrobial resistance in endemic settings.
Eligibility Criteria
Inclusion Criteria: * Age 9 months to 45 years at the time of vaccination * Resident of the defined study catchment area in Madagascar * Parent(s), legal guardian, or participant (if adult) able and willing to provide written informed consent (and assent where applicable) * Willing to comply with study procedures and follow-up for the duration of the study Exclusion Criteria: * Any medical or social condition that, in the opinion of the investigator, would interfere with participation or study procedures * Known allergy or hypersensitivity to any component of the Vi-CRM197 typhoid conjugate vaccine * Parent(s), legal guardian, or participant unwilling or unable to provide informed consent/assent
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07930988 clinical trial?
This trial is open to participants of all sexes, aged 9 Months or older, up to 45 Years, studying Salmonella Typhi Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07930988 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07930988 currently recruiting?
Yes, NCT07930988 is actively recruiting participants. Contact the research team at fmarks@ivi.int for enrollment information.
Where is the NCT07930988 trial being conducted?
This trial is being conducted at Antananarivo, Madagascar.
Who is sponsoring the NCT07930988 clinical trial?
NCT07930988 is sponsored by Rita Soares Barbosa Cardona. The trial plans to enroll 60,000 participants.