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This is a follow-up of a previous dose-ranging study aimed at investigating 2 doses of the trivalent inactivated split virion influenza vaccine when administered by intradermal route with that of the current pharmaceutical presentation administered by intramuscular route.
Primary Objective:
To assess the immunogenicity of two pharmaceutical presentations of the trivalent inactivated split virion influenza vaccine 21 days after a single injection in subjects aged 18 to 57 years.
Secondary Objective:
To evaluate the safety profile during the 21-day period following each vaccination in each study group
This is an open (for the administration route) and double-blind (only for the two dosages administered at year 0 by using the investigational administration route) randomized trial conducted in subjects aged 18 to 60 years. The subjects will receive three vaccine injections at 1-year interval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated, split-virion influenza vaccine | Biological | 0.1 mL, ID. 1 injection/year for 3 years |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To provide information concerning the immunogenicity of Inactivated, Split-Virion Influenza Vaccine. | 21days 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 Pasterur Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gribomont | Belgium | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19341446 | Derived | Beran J, Ambrozaitis A, Laiskonis A, Mickuviene N, Bacart P, Calozet Y, Demanet E, Heijmans S, Van Belle P, Weber F, Salamand C. Intradermal influenza vaccination of healthy adults using a new microinjection system: a 3-year randomised controlled safety and immunogenicity trial. BMC Med. 2009 Apr 2;7:13. doi: 10.1186/1741-7015-7-13. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Inactivated, split-virion influenza vaccine |
| Biological |
0.1 mL, ID. 1 injection/year for 3 years. |
|
| Inactivated, split-virion influenza vaccine | Biological | 0.5 mL, IM. 1 injection/year for 3 years |
|
|
| Kraainem |
| Belgium |
| Linkebeek | Belgium |
| Molenbeek | Belgium |
| Thuin | Belgium |
| Hradec Králové | Czechia |
| Kaunas | Lithuania |
| Vilnius | Lithuania |
| 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 |
|---|---|
| C478242 | vaxigrip |
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