ClinicalTrials.gg
Status unknownNCT05562102TyVECOUpdated Sep 30, 2022

TyVECO: Surveillance Protocol

An observational study in Typhoid Fever and Intestinal Perforation, sponsored by International Vaccine Institute. Status unknown at 9 sites in Democratic Republic of the Congo. Per ClinicalTrials.gov, last updated 2022-09-30.

Sponsored by International Vaccine Institute · Observational

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
48,000
Sex
All
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Study summary

In Kisantu Health Zone, approximate population 200,000, fever surveillance will be implemented in 8 health centers and 1 tertiary hospital. Individuals presenting to one of these study facilities with acute fever or history of fever or individuals presenting with suspicion of intestinal perforation irrespective of fever status, will be considered for enrollment. Following consent, blood samples (between 2.5 ml for children and 22 ml for adults) will be collected from eligible subjects and demographic and clinical information will be recorded in study forms at the time of enrollment at study health centers and hospitals. Peritoneal fluid and ileal tissue samples will be collected from surgical patients where possible. Biological specimens will be used for various testing, including microbiological culture of blood, tissue and peritoneal fluid for confirmation of bacterial growth, malaria diagnostics (microscopy and rapid testing), and storage of tissue samples for pathological investigation, and biobanking. Hospitalized patients will be followed-up to track clinical outcomes for the duration of hospitalization.

02

Conditions studied

  • Typhoid Fever
  • Intestinal Perforation
03

In context

Typhoid Fever

76 studies on the registry are indexed under Typhoid Fever; 11 are open to participants now.

This study's planned enrollment of 48,000 is above the median of 1,485 across 10 observational studies indexed under Typhoid Fever.

Browse Typhoid Fever studies →

Lead sponsor

International Vaccine Institute is the lead sponsor of 47 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The health care structure in the Democratic Republic of Congo is divided into Health Zones, each subdivided into Health Areas. Each Health Area contains first-line Health Posts and second-line Health Centers, which refer patients requiring advanced care to the Health Zone referral hospital. The study population includes both urban and rural areas and includes approximately 200,000 residents. The greatest distance from remote areas to the tertiary hospital is 80km.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

At health center:

  1. Patients of all ages currently living in the catchment area of the health center presenting to healthcare facility with objective fever of at least 38.0°C tympanic or 37.5 °C axillary OR
  2. Patients of all ages currently living in the catchment area of the health center presenting to healthcare facility with reported fever ≥3 consecutive days within 7 days of presentation

At Hospital:

  1. Suspicion of intestinal perforation/peritonitis due to typhoid fever requiring surgery for patients living in and outside the catchment area (even in the absence of laboratory confirmation) OR
  2. Patients living in the catchment area of the hospital with invasive salmonellosis confirmed through blood-culture surveillance embedded in routine patient cares

Exclusion criteria

Exclusion Criteria:

  • Individuals who do not provide
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
48,000 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Interventions

  • BiologicalTypbar-TCV, Bharat Biotech

    Typhoid conjugate vaccine

06

What researchers measure

Primary outcomes

  1. Typhoid fever

    Blood culture confirmed infection with Salmonella typhi

    Time frame: Three years from the time of vaccination

07

Study locations

9 of 9 sites recruiting
  • Cederi Madimba HC
    Kisantu, Bas-Congo Province, Democratic Republic of the Congo
    Recruiting
  • Gare HC
    Kisantu, Bas-Congo Province, Democratic Republic of the Congo
    Recruiting
  • Kavwaya HC
    Kisantu, Bas-Congo Province, Democratic Republic of the Congo
    Recruiting
  • Kikonka 1 HC
    Kisantu, Bas-Congo Province, Democratic Republic of the Congo
    Recruiting
  • Kintanu Etat HC
    Kisantu, Bas-Congo Province, Democratic Republic of the Congo
    Recruiting
  • Nkandu 1 HC
    Kisantu, Bas-Congo Province, Democratic Republic of the Congo
    Recruiting
  • Nkandu 3 HC
    Kisantu, Bas-Congo Province, Democratic Republic of the Congo
    Recruiting
  • Saint Luc Hospital
    Kisantu, Bas-Congo Province, Democratic Republic of the Congo
    Recruiting
  • Wete HC
    Kisantu, Bas-Congo Province, Democratic Republic of the Congo
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05562102
Lead sponsor
International Vaccine Institute
Responsible party
Sponsor
First posted
Sep 30, 2022
Start date
Aug 9, 2021
Primary completion
Mar 31, 2024 (estimated)
Completion
Mar 31, 2024 (estimated)
Last update
Sep 30, 2022

Study contacts

Octavie Lungaya, PhD
Contact
octmetila@yahoo.fr
+243-815-181-121
Justin Im, PhD
Contact
justin.im@ivi.int
+82-10-3296-0711

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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