A Phase 4 interventional study of Intanza and Intanza in Influenza, sponsored by Dalhousie University. Completed at 2 sites in Canada. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-15.
Sponsored by Dalhousie University · Phase 4, Interventional, and Prevention
The purpose of this study is to compare the immunogenicity and reactogenicity of self-administered intradermal influenza vaccine (Intanza)to nurse-administered.
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.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's planned enrollment of 276 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Dalhousie University is the lead sponsor of 50 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Self-administered intradermal influenza vaccine
Biological: Intanza
Nurse-administered intradermal influenza vaccine
Biological: Intanza
0.1 mL of Intanza intradermally at visit # 1
Also known as: Influenza Vaccine (Split Virion, Inactivated)
0.1 mL of Intanza intradermally at visit #1
Also known as: Influenza Vaccine (Split Virion, Inactivated)
Immunogenicity
That the immunogenicity of self-administered intradermal 2010/11 seasonal influenza vaccine (Intanza) is non-inferior to that of nurse administered intradermal 2010/11 seasonal influenza vaccine. Specifically, that ratio of increase in geometric mean titres between day 0 and day 21 post-vaccination are greater than 2/3 (i.e. GMT (IDS)/GMT (IDN) \> 0.65).
Time frame: 21 days post-vaccination
Reactogenicity
The reactogenicity of self-administered intradermal 2010/11 seasonal influenza vaccine (Intanza) is not significantly greater than that of nurse administered intradermal 2010/11 seasonal influenza vaccine.
Time frame: 7 days post-vaccination
Observational
85% or more of healthy adults can self-administer Intanza successfully; that is, they are willing to self-administer vaccine and successfully administer it, as judged by observation by a trained nurse.
Time frame: at vaccination
This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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Dalhousie University