Evaluation of Typhoid Conjugate Vaccine Effectiveness in Ghana

Launched by INTERNATIONAL VACCINE INSTITUTE · Apr 15, 2021

Keywords

ClinConnect Summary

This clinical trial, called TyVEGHA, is studying the effectiveness of a new typhoid vaccine in preventing typhoid fever in children and young people in Asante Akim, Ghana. The trial will compare groups of people who receive the vaccine to those who do not, to see how well the vaccine protects against serious cases of typhoid caused by the bacteria Salmonella Typhi. This research is important because typhoid fever can cause severe illness, and a safe and effective vaccine could help protect many lives.

To participate in the trial, individuals must be healthy children aged 9 months to 15 years and live in the targeted area. They also need to have the consent of a parent or guardian. Participants will receive the vaccine and will need to follow study procedures for the duration of the trial. It's important to note that certain individuals, such as those with allergies to vaccine components or those who are pregnant, cannot participate. If you're considering enrolling your child, you can expect support and guidance throughout the study process, helping to ensure their safety and well-being.

Gender

ALL

Eligibility criteria

• Inclusion Criteria: 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 Criteria: 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