NCT05119426

Effectiveness of a Typhoid Conjugate Vaccine in DRC

An Open-label Effectiveness Study of a Typhoid Conjugate Vaccine in Kisantu, Democratic Republic of Congo (TyVECO) - Step 2: Typhoid Conjugate Vaccine (TCV) Mass-vaccination Campaign

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48,000 (estimated)
• Sponsor: International Vaccine Institute · Academic / Other
• Sex: All
• Age: 9 Months – 15 Years
• Healthy volunteers: Accepted

Summary

This is a prospective cohort evaluation of vaccine effectiveness of a single dose of Typbar-TCV® against symptomatic blood culture-confirmed typhoid fever when administered through a mass vaccination campaign to children 9 months to \<16 years of age in Kisantu, DRC.

Detailed description

This study is conducted in Kisantu, DRC and is comprised of a mass vaccination campaign of children aged 9 months to \<16 years with a single dose of Typbar-TCV® and a concomitant surveillance study to assess the incidence of culture-confirmed typhoid fever in the population during a period of three years following vaccination. Safety events will be monitored for 30 minutes following vaccination for all participants. In a subset of age-eligible participants living in the study area, the investigators will assess local and systemic solicited adverse events/adverse reactions and unsolicited adverse events occurring within the first 7 days post-vaccination and unsolicited and serious adverse events within 28 days post-vaccination. A population census will be conducted at baseline to enumerate and characterize the population under study and demographic information will be collected to allow for minimization of potential sources of bias during analysis. An interim censuses and a census at study closure will be carried out to update population information. The investigators hypothesize that the Typbar-TCV® vaccine is effective in large scale vaccination campaigns, thereby lowering the incidence of blood-culture confirmed typhoid fever in children. Lessons and experiences on vaccination feasibility and uptake will be important for informing TCV introduction across the African continent.

Conditions

• Typhoid Fever

Interventions

Type	Name	Description
BIOLOGICAL	Vi-TT	Single dose of vaccine administered through a mass vaccine campaign to children between 9 months and \<16 years of age. The campaign will emulate vaccine delivery as would be administered in a local mass vaccination campaign.

Timeline

• Start date: 2022-02-11
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2021-11-15
• Last updated: 2023-04-18

Locations

25 sites across 1 country: Democratic Republic of the Congo