The Impact RTS,S/AS01 Vaccine in School Aged Children RTS,S/AS01 Malaria Vaccine in School Aged Children

Launched by KAMUZU UNIVERSITY OF HEALTH SCIENCES · May 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the RTS,S/AS01 malaria vaccine to see how well it works in school-aged children, specifically those between 6 and 15 years old. Malaria is a serious disease that affects many children in sub-Saharan Africa, leading to illness, missed school days, and difficulties in learning. The goal of the trial is to find out if the vaccine can help reduce the number of malaria cases in this age group, improve attendance in school, and enhance overall educational outcomes.

To be eligible for the trial, children must be enrolled in grades 1 to 8 and plan to stay in the study area for at least one year. Parents or guardians will need to give their consent for their child to participate, and children aged 13 and older will also need to agree to join. Participants can expect regular health check-ups and monitoring during the study. It's important to note that children with certain health issues, such as severe disabilities or specific infections, may not be able to participate. This trial is a valuable opportunity to help protect children's health and improve their futures through vaccination against malaria.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • Pupils aged approximately 6 years to 15 years and enrolled in Standard 1 - 8 in the participating schools
• • Planning to remain in the study area for 1 year
• • Parental/guardian consent for child's participation and child assent if the child is 13 years of age or older
• Exclusion criteria:
• • Pregnancy, defined based on menstrual history. Pupils who had their last menstrual period more than 6 weeks before enrollment will be excluded. This threshold was chosen considering that menstrual cycles are irregular in this age group
• • Viral infections resulting in fever, chills, new loss of taste/smell and sore throat
• • Known allergy or history of adverse reaction to antimalarial treatment or vaccines
• • Chronic use of anti-malarial medication, azithromycin, or cotrimoxazole
• • Enrollment in any other study
• • Evidence of heart disease, HIV, or epilepsy
• • Severe disability