Intradermal Influenza Vaccine With Topical Imiquimod in Elderly and Chronic Illness Patients
NCT04143451 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4000
Last updated 2021-04-28
Summary
To compare the safety and clinical efficacy (death, overall hospitalization, hospitalization for influenza or pneumonia) of ID QIV delivered via an intradermal device with imiquimod cream pretreatment with conventional intramuscular (IM) standard dose QIV and IM high-dose TIV
Conditions
Interventions
- BIOLOGICAL
-
Vaxigrip tetra
quadrivalent influenza vaccine
- BIOLOGICAL
-
Fluzone high-dose
high-dose trivalent influenza vaccine
- DRUG
-
Aldara 5% Topical Cream
imiquimod cream
- DRUG
-
Aqueous cream BP
inactive aqueous cream
Sponsors & Collaborators
-
The University of Hong Kong
lead OTHER
Principal Investigators
-
Ivan FN Hung, MD FRCP · The University of Hong Kong
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-10-23
- Primary Completion
- 2022-09-30
- Completion
- 2023-03-31
- FDA Drug
- Yes
Countries
- Hong Kong
Study Locations
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