Immunogenicity of Yellow Fever Vaccine in a Pediatric Population Vaccinated at 12-23 Months of Age in Argentina

Launched by MINISTRY OF PUBLIC HEALTH, ARGENTINA · Nov 30, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the immune response to the Yellow Fever vaccine in children who were vaccinated when they were between 12 and 23 months old. Researchers want to understand how well the vaccine is working now, four to seven years after the children received it. The trial is taking place in Northern Argentina, an area where yellow fever is a health risk. Children who participated in a previous study in 2015 and showed a good immune response to their first Yellow Fever vaccine dose are being contacted to take part in this new study.

To be eligible, children must have received one dose of the Yellow Fever vaccine in the 2015 study and must be healthy. Parents need to provide consent for their child to participate. If they join, the children will only need to provide a small blood sample, which will be sent to a lab to check for antibodies that help protect against yellow fever. This is important because it helps researchers understand if the vaccine is still effective and if additional booster shots may be needed in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Children enrolled in the 2015 study received one dose of YF vaccine and had documented seroconversion regardless of the
• • Healthy child, determined by clinical history
• • Availability to perform a single blood draw
• • Informed consent signed by the parents.
• Exclusion Criteria:
• • Children in the 2015 study received one dose of the Yellow Fever vaccine and had NO documented seroconversion.
• • Children enrolled in the 2015 study received a dose of the Yellow Fever vaccine and had documented seroconversion but, for different reasons, received a booster (minimum interval of one month between doses).
• • Children enrolled in the 2015 study received one dose of the Yellow Fever vaccine and had documented seroconversion but developed Yellow Fever
• • Children enrolled in the 2015 study received one dose of the Yellow Fever vaccine and had documented seroconversion but are participating in another clinical drug trial of a drug, vaccine, or medical device
• * Children enrolled in the 2015 study received a dose of the Yellow Fever vaccine and had documented seroconversion but, for various reasons, are immunocompromised:
• • Weakened immune function, including HIV infection, primary immunodeficiencies, having received immunosuppressive doses of oral or injectable corticosteroids (or equivalent), having received immunomodulators or chemotherapeutic agents, disease of the thymus, Severe illness/fever (mild illness without fever is not an exclusion criteria)
• • ● Any condition that, in the judgment of study personnel, poses a risk to the health of the participant or interferes with the assessment of response to the vaccine