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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-013672-45 | EudraCT Number |
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The present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate immunogenicity, safety and tolerability of two doses of adjuvanted and not-adjuvanted new swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy children and adolescents. 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 children and adolescent. Subjects will be randomized to receive 2 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) and schedule (one or two administrations) of the H1N1sw monovalent vaccine in children and adolescents | 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 | Belgium | |||||
| Santigo de chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25444803 | Derived | Knuf M, Leroux-Roels G, Rumke HC, Abarca K, Rivera L, Lattanzi M, Pedotti P, Arora A, Kieninger-Baum D, Della Cioppa G. Safety and immunogenicity of an MF59-adjuvanted A/H1N1 pandemic influenza vaccine in children from three to seventeen years of age. Vaccine. 2015 Jan 1;33(1):174-81. doi: 10.1016/j.vaccine.2014.10.085. Epub 2014 Nov 11. |
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|
| Santiago |
| Chile |
| Gazcue Santo Domingo | Gazcue Santo Domingo | Dominican Republic |
| Wurzburg, Fulda, Neumunster, Balve, Stuttgart-Feuerbach, Leipzig, Rostock, Mainz, Detmold, Alsfeld | Mainz | Germany |
| Rotterdam | Netherlands |