Typhoid Conjugate Vaccine Introduction in Madagascar (TyMA): Evaluation of the Real-World Effectiveness of the Vi-CRM197 Typhoid Conjugate Vaccine in Madagascar
NCT07930988, Phase 4, Recruiting, Rita Soares Barbosa Cardona
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Typhoid Conjugate Vaccine Introduction in Madagascar (TyMA): Evaluation of the Real-World Effectiveness of the Vi-CRM197 Typhoid Conjugate Vaccine in Madagascar | ClinicalTrials.gov |
| NCT number | NCT07930988 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 60,000 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Rita Soares Barbosa Cardona | ClinicalTrials.gov |
| Conditions | Salmonella Typhi Infection, Typhoid Fever | ClinicalTrials.gov |
| Interventions | Biological/Vaccine - Vi-CRM197 TCV | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Incidence of blood culture-confirmed typhoid fever (Salmonella Typhi) | From census enrollment up to 52 months | Incidence of typhoid fever defined as isolation of Salmonella enterica serovar Typhi from blood culture among individuals residing in the study catchment area. Vaccine effectiveness will be estimated by comparing incidence between individuals who received a single dose of Vi-CRM197 typhoid conjugate vaccine during the vaccination campaign and unvaccinated individuals within the censused population using active and enhanced facility-based surveillance. | ClinicalTrials.gov |
| Secondary | Incidence of clinically suspected typhoid fever | From census enrollment up to 52 months | Incidence of clinically suspected typhoid fever among residents of the study catchment area identified through active household surveillance and enhanced facility-based surveillance, regardless of laboratory confirmation. Comparisons will be made between vaccinated and unvaccinated individuals. | ClinicalTrials.gov |
| Secondary | Incidence of severe typhoid fever | From census enrollment up to 52 months | Incidence of severe typhoid fever, including cases requiring hospitalization or presenting with severe complications, among vaccinated and unvaccinated individuals in the study population | ClinicalTrials.gov |
| Secondary | Solicited and unsolicited adverse events following vaccination | Solicited adverse events: Days 0-7 post-vaccination of a subset of participants; Unsolicited adverse evetns : up to 28 days pos vaccination. Aerious adverse events: From vaccination enrollment up to 52 months | Occurrence of solicited local and systemic adverse events within 7 days after vaccination and unsolicited adverse events and serious adverse events during follow-up among participants receiving the Vi-CRM197 vaccine. | ClinicalTrials.gov |
| Secondary | Anti-Vi IgG antibody response following vaccination | Baseline to 24 months post-vaccination | Immunogenicity assessed by seroconversion (≥4-fold rise in anti-Vi IgG titers from baseline) and geometric mean titers measured in a subset of vaccinated participants at predefined time points after vaccination. | ClinicalTrials.gov |
| Secondary | Carriage of antimicrobial resistance markers | Baseline to 12 months | Prevalence and changes in antimicrobial resistance markers in gastrointestinal and respiratory samples among vaccinated and unvaccinated individuals in a subset cohort. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.