CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 100 enrolled
Drug / intervention
Inactivated influenza vaccine +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02438423
NCT02438423Phase 1Completed
CompareCT.gov

A Phase I Study of the Safety, Reactogenicity, Acceptability and Immunogenicity of Inactivated Influenza Vaccine Delivered by Microneedle Patch or by Hypodermic Needle

Mark Prausnitz·interventional·Posted May 8, 2015·Updated Jul 5, 2019

In Brief

A Phase 1 clinical trial evaluating Inactivated influenza vaccine and Placebo for Influenza. Completed, enrolled 100 participants across 1 site.

Detailed Summary

Title: A Phase I Study of The Safety, Reactogenicity, Acceptability and Immunogenicity of Inactivated Influenza Vaccine Delivered either by Microneedle Patch or by Hypodermic Needle. This is a single center, partially blinded, randomized phase I study in which healthy adult subjects (ages 18-49) will receive either inactivated influenza vaccine (IIV) (either by microneedle patch or hypodermic needle) or placebo (by microneedle patch). This study is designed to investigate the safety, reactogenicity, acceptability and immunogenicity of an inactivated influenza vaccine delivered by microneedle patch.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
CollaboratorsEmory University

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 8, 2015
Enrollment StartJun 1, 2015
Primary CompletionMar 23, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 11.2 years ago

Interventions

Inactivated influenza vaccinebiological

Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season

Placeboother