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The purpose of this study is to test different adjuvanted vaccine formulations as a two-dose schedule in immunologically naïve adults against one vaccine formulation without adjuvant in terms of tolerance and immunogenicity
Primary Objective:
To describe the safety profile and immunogenicity following each injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Dose 1 with Adjuvant |
|
| Group 2 | Experimental | Dose 2 with adjuvant |
|
| Group 3 | Experimental | Dose 3 with adjuvant |
|
| Group 4 | Experimental | Dose 4 with adjuvant |
|
| Group 5 | Active Comparator | Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| To provide information concerning the safety of A/H5N1 Inactivated split influenza virus vaccine | Entire study period |
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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 |
|---|---|---|---|---|---|---|
| Brussels | Belgium | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18576945 | Derived | Levie K, Leroux-Roels I, Hoppenbrouwers K, Kervyn AD, Vandermeulen C, Forgus S, Leroux-Roels G, Pichon S, Kusters I. An adjuvanted, low-dose, pandemic influenza A (H5N1) vaccine candidate is safe, immunogenic, and induces cross-reactive immune responses in healthy adults. J Infect Dis. 2008 Sep 1;198(5):642-9. doi: 10.1086/590913. |
| Label | URL |
|---|---|
| Related Info | View source |
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| A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant | Biological | 0.5 mL, Intramuscular |
|
| A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant | Biological | 0.5 mL, Intramuscular |
|
| A/H5N1 inactivated, split-virion influenza vaccine+Adjuvant | Biological | 0.5 mL, Intramuscular |
|
| A/H5N1 inactivated, split-virion influenza vaccine | Biological | 0.5 mL, Intramuscular |
|
| Ghent |
| Belgium |
| Leuven | Belgium |
| ID | Term |
|---|---|
| D009976 | Orthomyxoviridae Infections |
| D005585 | Influenza in Birds |
| ID | Term |
|---|---|
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D001715 | Bird Diseases |
| D000820 | Animal Diseases |
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