A Phase 4 interventional study of Vi-TT and MCV-A vaccine in Typhoid Fever, sponsored by International Vaccine Institute. Recruiting at 1 site in Ghana. Open to participants aged 9 Months to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-08.
Sponsored by International Vaccine Institute · Phase 4, Interventional, and Prevention
Among 11 studies in Typhoid Fever by International Vaccine Institute — 1 open to participants now, 1 under way, none of them phase 3. Typhoid Fever · International Vaccine Institute.
Among the 11 studies in Typhoid Fever by International Vaccine Institute, this one is the 6th largest by planned enrollment of the 10 interventional ones, is one of 2 that started in 2021, is one of 6 in phase 4, and was the 9th registered.
76 studies on the registry are indexed under Typhoid Fever; 11 are open to participants now.
This study's planned enrollment of 23,000 is above the median of 147 across 65 interventional studies indexed under Typhoid Fever.
Browse Typhoid Fever studies →1 of the 11 studies in Typhoid Fever by International Vaccine Institute is open now, in 1 country. Each count lists the studies.
Of the 6 Typhoid Fever studies recruiting now, 2 (33%) set no upper age limit and 4 (67%) stop at 75 or younger; 4 take children under 18; 5 take healthy volunteers.
This study: 9 Months to 15 Years · all sexes · healthy volunteers too.
The full table on the hub →11 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 2 started in 2021.
Median enrollment 25,116 across the 10 interventional studies, 48,000 across the 1 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
International Vaccine Institute is the lead sponsor of 47 studies on the registry; 12 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Typhoid Fever by International Vaccine Institute, from their registry updates:
Nothing recorded among them since 2026-09-25.
A cluster-randomised controlled Phase IV trial (cRCT) assessing the impact of a Vi-Polysaccharide conjugate vaccine in preventing typhoid infection in Asante Akim, Ghana (TyVEGHA) with a primary endpoint of determining the total protection conferred by single-dose vaccination with Vi-TT against blood culture-confirmed symptomatic S. Typhi infection in the intervention vaccine clusters, compared with the control vaccine clusters.
Typhoid fever remains a significant health problem in sub-Saharan Africa, with incidence rates >100 cases per 100,000 person-years of observation. Despite the prequalification of safe and effective typhoid conjugate vaccines (TCV), the uptake of these vaccines in African countries has remained low. Real-life effectiveness data, which inform public health programs on the impact of TCVs in reducing typhoid-related mortality and morbidity, are critical to enhancing the introduction of TCVs in high-burden settings. Here we describe a cluster-randomized trial to investigate population-level protection of TCV against blood culture-confirmed typhoid fever. A total of 80 geographically distinct clusters have been delineated within the Agogo district of the Asante Akim region in Ghana. Clusters will be randomized to the intervention arm receiving TCV or a control arm receiving the meningococcal A conjugate vaccine. The primary study endpoint is the overall protection of TCV against blood culture-confirmed typhoid fever. Total, direct, and indirect protection will be measured as secondary outcomes. Blood culture-based enhanced surveillance will enable the estimation of incidence rates in the intervention and control clusters. Evaluation of the real-world impact of TCVs will improve uptake of prequalified/licensed safe and effective typhoid vaccines in public health programs of high burden settings.
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet the following criteria:
Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study:
Temporary exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A single dose of Vi-TT to children 9 months to 15 years of age.
Biological: Vi-TT
A single dose of MCV-A vaccine to the comparator group.
Biological: MCV-A vaccine
Single-dose V-TT administered to children and adolescents between the ages of 9 months to 15 years.
Single-dose of MCV-A vaccine (a meningococcal vaccine)
Total Protection
The incidence of blood culture-confirmed symptomatic TF in all vaccine recipients of the intervention clusters, compared with control clusters.
Time frame: 3 years
Safety Assessment
1) Proportion of adverse events in participants receiving Vi-TT compared with MCV-A, measured by: * The proportion of participants in each group of a sub-sample of the cohort developing adverse events/adverse reactions within the first 7 days post-vaccination. * The proportion of participants in each group of the cohort developing serious adverse events during the entire study period, as determined by self-reporting at follow-up contact.
Time frame: 3 years
Overall protection
The incidence of blood culture-confirmed symptomatic TF in all residents of the intervention clusters compared with that in all residents of control clusters
Time frame: 3 years
Total protection against severe typhoid.
The incidence of severe TF in vaccinated individuals in intervention clusters compared to control clusters
Time frame: 3 years
Total protection against clinical typhoid.
The incidence of clinical typhoid fever cases, defined as persistent fever (tympanic (≥38.0℃) or axillary temperature (≥37.5℃) or reported fever for ≥3 consecutive days) with abdominal complaints at a study surveillance site in vaccinated individuals in intervention clusters compared to control clusters.
Time frame: 3 years
Overall protection against clinical typhoid.
The incidence of clinical typhoid fever cases presenting at a study surveillance site among all residents of the Vi-TT clusters compared to the control vaccine clusters.
Time frame: 3 years
Indirect Protection aganist Blood Culture Confirmed Typhoid.
The incidence of blood culture-confirmed symptomatic TF in non-vaccinees of the intervention clusters compared with control clusters.
Time frame: 3 years
Seroconversion rates
The seroconversion rates as measured by enzyme linked immunosorbent assay (anti-Vi IgM and IgG) for S. Typhi and iNTS at defined time points in a age-stratified subset of intervention and control vaccinees.
Time frame: 3 years
Geometric mean titers
The antibody concentration as measured by enzyme linked immunosorbent assay (anti-Vi IgM and IgG) for S. Typhi and iNTS at defined time points in a age-stratified subset of intervention and control vaccinees.
Time frame: 3 years
Plan to share: No — Sharing can be considered on a case-by-case basis considering the intended use and impact.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
International Vaccine Institute