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

NCT05315024 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2022-04-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Fluarix Tetra

Fluarix Tetra

DRUG

Imiquimod cream

Imiquimod cream

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Gilbert T Chua · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05315024 on ClinicalTrials.gov