NCT00623181

Study to Determine a Preference for Fluzone Vaccine Given Intradermally (ID) and Intramuscularly (IM) in Healthy Adults

Preference for Fluzone Vaccine Administered Intradermally Versus Intramuscularly in Healthy Adult Subjects 18-49 Years of Age

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

To describe any degree of preference for the route of administration of Fluzone influenza vaccine, ID versus IM, in healthy adult subjects 18-49 years of age. To collect safety data, injection site reactions, and systemic reactions, through Day 7 post-vaccination; SAEs through day 28 post-vaccination

Detailed description

The purpose of this clinical trial is to determine, in a relatively small sample of persons 18-49 years of age, if there is a preference trend for a particular route of administration, ID vs IM, when receiving a seasonal influenza vaccine. Uptake of influenza vaccine is disappointingly low in this age group, and there is the perception that aversion to IM injection plays a role in vaccination avoidance. The BD Micro-Injection System to be used in this study may offer a more acceptable alternative to the standard IM injection for influenza immunization and thereby promote wider acceptance of influenza vaccination.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Fluzone: Influenza virus vaccine	0.1 mL, Intradermal Right deltoid, 0.5 mL, Intramuscular Left deltoid
BIOLOGICAL	Fluzone: Influenza virus vaccine	0.5 mL, Intramuscular Right deltoid, 0.1 mL, Intradermal Left deltoid

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-05-01
• Completion: 2008-06-01
• First posted: 2008-02-25
• Last updated: 2016-04-14
• Results posted: 2011-08-11

Locations

2 sites across 1 country: United States