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To further characterize the immune responses induced after an influenza vaccination performed either via the ID or the IM routes in two clearly distinct populations.
Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group 1 | Experimental | Adult, age 18 to 40 years |
|
| Study Group 2 | Experimental | Adult, age 18 to 40 years |
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| Study Group 3 | Experimental | Elderly, age 60 to 85 years |
|
| Study Group 4 | Experimental | Elderly, age 60 to 85 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated, split-virion, influenza vaccine | Biological | 0.1 mL, Intradermal |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To provide information concerning immune response to an inactivated, split-virion, influenza vaccine. | 21 days post-vaccination | |
| To provide information concerning the safety of inactivated, split-virion, influenza vaccine. | 21 days post-vaccination and entire study duration |
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Inclusion Criteria :
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Sanofi Pasteur Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyon Sud | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25483667 | Result | Nougarede N, Bisceglia H, Rozieres A, Goujon C, Boudet F, Laurent P, Vanbervliet B, Rodet K, Hennino A, Nicolas JF. Nine mug intradermal influenza vaccine and 15 mug intramuscular influenza vaccine induce similar cellular and humoral immune responses in adults. Hum Vaccin Immunother. 2014;10(9):2713-20. doi: 10.4161/hv.29695. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Inactivated, split-virion, influenza vaccine |
| Biological |
0.5 mL, Intramuscular |
|
|
| Inactivated, split-virion influenza vaccine | Biological | 0.1 mL, Intradermal |
|
| Inactivated, split-virion influenza vaccine | Biological | 0.5 mL, Intramuscular |
|
|
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D009976 | Orthomyxoviridae Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| C478242 | vaxigrip |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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