Effectiveness of a Typhoid Conjugate Vaccine in DRC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

48000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-11

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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

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Typhoid Fever

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Vi-TT

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

Group Type EXPERIMENTAL

Vi-TT

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Other Intervention Names

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Typbar TCV

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

9 Months

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florian Marks, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cambridge

Octavie Lunguya, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut National de Research Biomédicale

Locations

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