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Inactivated Influenza Vaccine Delivered by Microneedle Patch or by Hypodermic Needle

NCT02438423 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-07-05

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Inactivated influenza vaccine

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

OTHER

Placebo

Sponsors & Collaborators

  • Emory University

    collaborator OTHER

  • Mark Prausnitz

    lead OTHER

Principal Investigators

  • Nadine Rouphael, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-03-23
Completion
2016-03-23

Countries

  • United States

Study Locations

More Related Trials

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 NCT02438423 on ClinicalTrials.gov