Intradermal Influenza Vaccine in the Young
NCT02103023 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2014-12-05
Summary
Influenza poses a heavy burden to our health service. The WHO estimates that seasonal influenza causes 250,000-500,000 deaths worldwide each year. Various strategies including intradermal vaccination and new vaccine adjuvants have been shown to improve immunogenicity. Recently, imiquimod, a synthetic Toll-like receptor 7 (TLR7) agonist useful for the treatment of DNA virus infection, have been shown to improve vaccine immunogenicity against influenza virus in mouse model. The objective of this prospective double-blind randomized controlled trial is to evaluate the effect and safety of topical treatment with imiquimod immediately before intradermal influenza vaccination in healthy young adults.
Conditions
- Influenza Viral Infections
Interventions
- DRUG
-
Imiquimod ointment
5% 250mg imiquimod ointment
- DRUG
-
Aqueous cream
aqueous cream
- BIOLOGICAL
-
Intradermal influenza vaccine
intradermal trivalent influenza vaccine (Intanza15)
- BIOLOGICAL
-
Intramuscular influenza vaccine
intramuscular trivalent influenza vaccine (Vaxigrip)
Sponsors & Collaborators
-
The University of Hong Kong
lead OTHER
Principal Investigators
-
Kwok-Yung Yuen, MD FRCP · The University of Hong Kong
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 30 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-03-31
- Primary Completion
- 2014-11-30
- Completion
- 2014-11-30
Countries
- China
Study Locations
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