Brief 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

48,000

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Feb 2022

Typical duration for phase_4

Geographic Reach

1 country

25 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.8 years study duration

First Submitted

Initial submission to the registry

October 18, 2021

Completed

28 days until next milestone

First Posted

Study publicly available on registry

November 15, 2021

Completed

3 months until next milestone

Study Start

First participant enrolled

February 11, 2022

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed

Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

2.8 years

First QC Date

October 18, 2021

Last Update Submit

April 16, 2023

Conditions

Typhoid Fever

Keywords

Typhoid conjugate vaccineVaccine effectivenessMass vaccination campaignDemocratic Republic of Congo (DRC)

Outcome Measures

Primary Outcomes (1)

Direct vaccine effectiveness of Typbar-TCV®
Comparison of incidence of blood culture confirmed Salmonella Typhi infection in participants 9 months to \<16 years of age vaccinated with a single dose of Typbar-TCV® delivered through a mass vaccination campaign and unvaccinated participants 9 months to \<16 years of ageSalmonella Typhi isolated from blood specimens using conventional microbiological techniques
3 years

Secondary Outcomes (5)

Overall vaccine effectiveness of Typbar-TCV®
3 years
Total vaccine effectiveness of Typbar-TCV®
3 years
Indirect vaccine effectiveness of Typbar-TCV®
3 years
Safety profile of Typbar-TCV®
28 days
Feasibility of a single-dose Typbar-TCV® mass campaign in Kisantu, DRC
3 years

Study Arms (1)

Vi-TT

EXPERIMENTAL

Single dose of Vi-TT to children 9 months to \<16 years of age

Biological: Vi-TT

Interventions

Vi-TTBIOLOGICAL

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.

Also known as: Typbar TCV

Vi-TT

Eligibility Criteria

Age9 Months - 15 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

Parent/guardian willing and able to provide informed consent; assent will be sought for participants between 12 and \<16 years of age
Resident of the defined study area, Kisantu Health Zone at the time of vaccination
Age between 9 months and \<16 years (i.e., ≤15 years and 364 days) on the day of vaccination

You may not qualify if:

The participant has a known allergy to any of the vaccine components,
Any medical reason perceived to increase risk to health posed by vaccination as judged by a medical professional
Self-reported pregnancy in females greater or equal to 11 years of age who have reported menarche

Contact the study team to confirm eligibility.