Effectiveness of a Typhoid Conjugate Vaccine in DRC (TyVECO)

International Vaccine Institute (IVI)

Status and phase

Enrolling

Phase 4

Conditions

Typhoid Fever

Treatments

Biological: Vi-TT

Study type

Interventional

Funder types

Other

Identifiers

NCT05119426

2021-009

Details and patient eligibility

About

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.

Full 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.

Enrollment

48,000 estimated patients

Sex

All

Ages

9 months to 15 years old

Volunteers

Accepts Healthy Volunteers

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