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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
48,000
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.
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
Time frame: 3 years
Overall vaccine effectiveness of Typbar-TCV®
Comparison of incidence of blood culture confirmed Salmonella Typhi infection in all individuals 9 months to \<16 years of age residing in clusters with lowest vaccine coverage (delineated virtually using GIS data) and all individuals 9 months to \<16 years of age residing in clusters with highest vaccine coverage
Time frame: 3 years
Total vaccine effectiveness of Typbar-TCV®
Comparison of the incidence of blood culture confirmed Salmonella Typhi infection in vaccinated individuals 9 months to \<16 years of age residing in clusters with highest vaccine coverage (delineated virtually using GIS data) versus unvaccinated individuals 9 months to \<16 years of age residing in clusters with lowest vaccine coverage
Time frame: 3 years
Indirect vaccine effectiveness of Typbar-TCV®
Comparison of the incidence of blood culture confirmed Salmonella Typhi infection in unvaccinated individuals 9 months to \<16 years residing in clusters with lowest levels of vaccine coverage (delineated virtually using GIS data) versus unvaccinated individuals 9 months to \<16 years of age residing in clusters with highest levels of vaccine coverage
Time frame: 3 years
Safety profile of Typbar-TCV®
Proportion of participants developing local and systemic solicited adverse events/adverse reactions and unsolicited adverse events within the first 7 days post-vaccination in a subset of vaccinees and unsolicited and serious adverse events within 28 days post-vaccination
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Cerphytoco
Kisantu, Bas-Congo Province, Democratic Republic of the Congo
COMPLETEDCS Cederi Madimba
Kisantu, Bas-Congo Province, Democratic Republic of the Congo
COMPLETEDCS Kavuaya
Kisantu, Bas-Congo Province, Democratic Republic of the Congo
COMPLETEDCS Kilenda
Kisantu, Bas-Congo Province, Democratic Republic of the Congo
COMPLETEDCS Kimuisi
Kisantu, Bas-Congo Province, Democratic Republic of the Congo
COMPLETEDCS Kinkonko
Kisantu, Bas-Congo Province, Democratic Republic of the Congo
NOT_YET_RECRUITINGCS Kintanu Etat
Kisantu, Bas-Congo Province, Democratic Republic of the Congo
COMPLETEDCS Kipako
Kisantu, Bas-Congo Province, Democratic Republic of the Congo
RECRUITINGCS Kipasa
Kisantu, Bas-Congo Province, Democratic Republic of the Congo
NOT_YET_RECRUITINGCS Kivuangi
Kisantu, Bas-Congo Province, Democratic Republic of the Congo
COMPLETED...and 15 more locations
Time frame: 28 days
Feasibility of a single-dose Typbar-TCV® mass campaign in Kisantu, DRC
Descriptive report assessing both the scientific feasibility, including the ability of the study team to measure the above-named objectives, and operational feasibility, focusing on logistical aspects of the study conduct
Time frame: 3 years