drugset / Trial / NCT05315024

Influenza Vaccine With Topical Imiquimod in Influenza Vaccine Non-responsive Children

NCT05315024

Unknown 72 enrolled The University of Hong Kong
RandomizedParallel-groupOpen-labelPrevention

Summary

Aims and hypotheses to be tested: Primary objective \- To compare the IIV responses, in terms of seroconversion rates, using ID IIV with topical 5% imiquimod (IIV-Q-ID), ID influenza vaccine alone (IIV-ID), and the second dose of IM influenza vaccine (IIV-IM) among children who are IIV non-responders. Secondary objectives * To determine the IIV non-responder rate in healthy Hong Kong children. * To investigate the association between HLA molecules and IIV non-responsiveness. Hypotheses * The investigators hypothesize that among IIV non-responder children, the seroconversion rate after ID IIV with topical imiquimod will be significantly higher than a second IM IIV dose. * The investigators hypothesize that the IIV non-responder rate is approximately 5-10% in the paediatric population. * The investigators hypothesize that certain HLA alleles are associated with IIV non-responders.

Timeline

Start
2022-04-30
Primary completion
2023-09-30
Completion
2023-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluarix Tetra Vaccine 0.1 ml Intramuscular
Subject Fluarix Tetra Vaccine 0.5 ml Intramuscular
Subject Imiquimod Other / unclassified 5 % Topical

Indications