Status:
UNKNOWN
Influenza Vaccine With Topical Imiquimod in Influenza Vaccine Non-responsive Children
Lead Sponsor:
The University of Hong Kong
Conditions:
Influenza
Eligibility:
All Genders
8-18 years
Phase:
NA
Brief 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 (...
Detailed Description
This study is a cross-over randomized-controlled trial (RCT). The outline of the study is shown in Figure 1. This study is divided into two parts: (i) screening for vaccine non-responders; and (ii) RC...
Eligibility Criteria
Inclusion
- Age 8-18 years old
- Subjects receiving IIV influenza vaccination through the Seasonal Influenza Vaccination School Outreach Programme.
Exclusion
- Age \<8 years old to avoid the need for second dose vaccine in case the subjects have never had influenza vaccines before
- Age \>18 years old
- Received any forms of influenza vaccines, including the intranasal live-attenuated influenza vaccines or inactivated vaccines, in the past six months
- Underlying chronic illnesses, including immunodeficiencies or autoimmune diseases
- Using immunosuppressive reagents, such as long-term corticosteroids, and other steroid-sparing reagents 6 months prior to the recruitment
- Received intravenous immunoglobulin or other blood products 3 months prior to the recruitment
- Had upper respiratory tract infection symptoms within two weeks before the vaccination, including fever, cough, sore throat, and coryza
- Previous allergic reactions to imiquimod, influenza vaccines, and their excipients.
Key Trial Info
Start Date :
April 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2023
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05315024
Start Date
April 30 2022
End Date
October 30 2023
Last Update
April 18 2022
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