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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-013671-21 | EudraCT Number |
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This present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate immunogenicity, safety and tolerability of two doses of an adjuvanted and not-adjuvanted new swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy adult and elderly subjects. A booster dose will be administered 12 months after the first vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low dose of antigen + low dose of adjuvant | Experimental |
| |
| high dose of antigen + high dose of adjuvant | Experimental |
| |
| high dose of antigen | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monovalent A/H1N1 influenza vaccine | Biological | This trial will be performed at multiple study sites in a population of healthy adults and elderly. Subjects will be randomized to receive two IM injections of low dose of antigen & adjuvant,or high dose of antigen & adjuvant, or high dose of antigen, according to the study groups |
| Measure | Description | Time Frame |
|---|---|---|
| To identify the preferred vaccine formulation, dosage (antigen & adjuvant), schedule (one or two administrations) of the H1N1 sw monovalent vaccine in adults | 43 days after first vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate immunogenicity against A/California H1N1sw strain after booster dose of egg-derived seasonal trivalent, MF59 adjuvanted vaccine Fluad, recommended for 2010/2011 season, administered 12 months after primary course according to CHMP criteria | 3 weeks after booster vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gent, Antwerpen | Antwerp | Belgium | ||||
| Munchen, Wurzburg, Balve, Leipzig, Magdeburg, Hamburg, Rostock, Mainz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22446638 | Derived | Hatz C, von Sonnenburg F, Casula D, Lattanzi M, Leroux-Roels G. A randomized clinical trial to identify the optimal antigen and MF59((R)) adjuvant dose of a monovalent A/H1N1 pandemic influenza vaccine in healthy adult and elderly subjects. Vaccine. 2012 May 14;30(23):3470-7. doi: 10.1016/j.vaccine.2012.03.017. Epub 2012 Mar 22. |
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|
| Mainz |
| Germany |
| Basel | Switzerland |
| Zurich | Switzerland |