Effectiveness of a Typhoid Conjugate Vaccine in DRC

Last updated: April 16, 2023
Sponsor: International Vaccine Institute
Overall Status: Active - Recruiting

Phase

4

Condition

Intra-abdominal Infections

Treatment

N/A

Clinical Study ID

NCT05119426
2021-009
  • Ages 9-15
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Parent/guardian willing and able to provide informed consent; assent will be soughtfor 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 ofvaccination

Exclusion

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 judgedby a medical professional
  • Self-reported pregnancy in females greater or equal to 11 years of age who havereported menarche

Study Design

Total Participants: 48000
Study Start date:
February 11, 2022
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • CS Cederi Madimba

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Completed

  • CS Kavuaya

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Completed

  • CS Kilenda

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Completed

  • CS Kimuisi

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Completed

  • CS Kinkonko

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Site Not Available

  • CS Kintanu Etat

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Completed

  • CS Kipako

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Active - Recruiting

  • CS Kipasa

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Site Not Available

  • CS Kivuangi

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Completed

  • CS Lemfu

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Site Not Available

  • CS Ngeba

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Active - Recruiting

  • CS Saint Pierre Boko

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Completed

  • CS Yimbi

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Completed

  • Cerphytoco

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Completed

  • Gare

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Completed

  • Kimayala

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Completed

  • Nkandu 1

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Completed

  • Nkandu 2

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Completed

  • Nkandu 3

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Completed

  • PS Kilemfu Nkanga

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Completed

  • PS Kongo Nord

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Completed

  • PS Ngombi Kinsambu

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Completed

  • Site avancé de Kinsambamba

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Completed

  • Unadic

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Completed

  • Wete

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Completed

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