NCT01224613

Study to Compare Self-administered and Nurse-administered Intradermal Influenza Vaccine

A Randomized Controlled Trial To Compare The Immunogenicity Of Self-Administered And Nurse-Administered Intradermal Influenza Vaccine

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 276 (estimated)
• Sponsor: Dalhousie University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the immunogenicity and reactogenicity of self-administered intradermal influenza vaccine (Intanza)to nurse-administered.

Detailed description

Participants will be randomized at visit one to either receive self-administered or nurse-administered intradermal influenza vaccine (Intanza). A blood sample will be taken prior to vaccination and 21 days post-vaccination. Participants will record information in a memory aid for 7 days including daily temperatures, solicited, unsolicited and general reactions. They will be called on study Day 8 to collect this information. Participants will return 21-24 days later for follow-up serology and review of adverse events.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Intanza	0.1 mL of Intanza intradermally at visit # 1
BIOLOGICAL	Intanza	0.1 mL of Intanza intradermally at visit #1

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-01-01
• Completion: 2011-02-01
• First posted: 2010-10-20
• Last updated: 2011-06-15

Locations

2 sites across 1 country: Canada