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| Name | Class |
|---|---|
| IWK Health Centre | OTHER |
| MCM Vaccines B.V. | INDUSTRY |
| Mount Sinai Hospital, Canada | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intanza - self-administered | Active Comparator | Self-administered intradermal influenza vaccine |
|
| Intanza - nurse-administered | Active Comparator | Nurse-administered intradermal influenza vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intanza | Biological | 0.1 mL of Intanza intradermally at visit # 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 21 days post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 days post-vaccination |
| Observational |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shelly McNeil, MD | Canadian Center for Vaccinology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canadian Center for Vaccinology | Halifax | Nova Scotia | B3K 6R8 | Canada | ||
| Mount Sinai Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22902784 | Derived | Coleman BL, McGeer AJ, Halperin SA, Langley JM, Shamout Y, Taddio A, Shah V, McNeil SA. A randomized control trial comparing immunogenicity, safety, and preference for self- versus nurse-administered intradermal influenza vaccine. Vaccine. 2012 Sep 28;30(44):6287-93. doi: 10.1016/j.vaccine.2012.08.006. Epub 2012 Aug 16. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Intanza | Biological | 0.1 mL of Intanza intradermally at visit #1 |
|
|
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. |
| at vaccination |
| Toronto |
| Ontario |
| M5K 1X5 |
| Canada |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |