Status:
RECRUITING
Evaluation of Typhoid Conjugate Vaccine Effectiveness in Ghana
Lead Sponsor:
International Vaccine Institute
Collaborating Sponsors:
Kwame Nkrumah University of Science and Technology
University of Cambridge
Conditions:
Typhoid Fever
Eligibility:
All Genders
9-15 years
Phase:
PHASE4
Brief Summary
A cluster-randomised controlled Phase IV trial (cRCT) assessing the impact of a Vi-Polysaccharide conjugate vaccine in preventing typhoid infection in Asante Akim, Ghana (TyVEGHA) with a primary endpo...
Detailed Description
Typhoid fever remains a significant health problem in sub-Saharan Africa, with incidence rates \>100 cases per 100,000 person-years of observation. Despite the prequalification of safe and effective t...
Eligibility Criteria
Inclusion
- In order to be eligible to participate in this study, an individual must meet the following criteria:
- Healthy participants aged 9 months to \<16 years (i.e., ≤15 years and 364 days) of age at the time of vaccination
- Participants/Parents/legally authorized representative (LAR) who have voluntarily given informed assent (sought from participants aged 12 years to \<16 years) and informed consent
- Participants/Parents/LAR living within study target area at the time of vaccination and willing to follow the study procedures and be available for the entire duration of the study
Exclusion
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Known allergy to any vaccine component
- Self-reported ongoing acute and/or chronic illness
- Any self-reported coagulopathies
- Any medical or social compelling reasons in the judgment of a clinical physician
- Self-reported pregnancy/Positive urine pregnancy test or lactating
- Previous typhoid vaccination in the last 5 years (proven by the presentation of a vaccine card or self-reporting).
- Temporary exclusion criteria
- Self-reported fever (elevated tympanic (≥38°C) or axillary temperature (≥37.5°C)) within 24 hours of vaccination
- Self-reported use of antipyretics within 4hours prior to vaccination
- Any other vaccination during the last 4 weeks (proven by the presentation of a vaccine card or self-reporting)
- Girls ≥11 years of age with self-reported irregular menstruation or who do not know their last menstruation date
Key Trial Info
Start Date :
August 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
23000 Patients enrolled
Trial Details
Trial ID
NCT04852185
Start Date
August 24 2021
End Date
December 31 2024
Last Update
March 8 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kwame Nkrumah University of Science and Technology
Kumasi, Ashanti Region, Ghana, PMB