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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-002480-27 |
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Evaluate the immune response and reactogenicity of H5N1 vaccination in subjects aged 6 months to 17 years compared to seasonal flu vaccination
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | 0.5mL of H5N1 vaccine 7.5ug |
|
| Arm 2 | Active Comparator | 0.25 or 0.5mL of H5N1 vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H5N1 Influenza Vaccine | Biological | Two 0.5mL injections of H5N1 influenza vaccine containing 7.5μg of H5N1 antigen (A/Vietnam/1194/2004), administered 3 weeks apart, and one 0.5mL injection of H5N1 vaccine 12 months after the second dose, IM into the deltoid muscle (preferably of the non-dominant arm) or anterolateral thigh (depending on the muscle mass). |
| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerability of, and magnitude of antibody responses to two 0.5mL intramuscular injections of an H5N1 influenza vaccineapart | administered 3 weeks apart |
| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerability of, and magnitude of antibodies to one booster dose with a H5N1 | 12 months after primary immunization | |
| safety profile of a H5N1 compared to a seasonal flu vaccinepersistence of specific antibodies | 12 months after primary immunization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tampere Medical School | Tampere | 33014 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20819892 | Result | Vesikari T, Karvonen A, Tilman S, Borkowski A, Montomoli E, Banzhoff A, Clemens R. Immunogenicity and safety of MF59-adjuvanted H5N1 influenza vaccine from infancy to adolescence. Pediatrics. 2010 Oct;126(4):e762-70. doi: 10.1542/peds.2009-2628. Epub 2010 Sep 6. | |
| 22777094 | Derived | Vesikari T, Forsten A, Borkowski A, Gaitatzis N, Banzhoff A, Clemens R. Homologous and heterologous antibody responses to a one-year booster dose of an MF59((R)) adjuvanted A/H5N1 pre-pandemic influenza vaccine in pediatric subjects. Hum Vaccin Immunother. 2012 Jul;8(7):921-8. doi: 10.4161/hv.20248. Epub 2012 Jul 1. |
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|
| H5N1 Influenza Vaccine | Biological | Two 0.25mL or 0.5mL injections of H5N1 influenza vaccine, administered 3 weeks apart, IM into the deltoid muscle (preferably of the non-dominant arm) or anterolateral thigh (depending on the muscle mass). |
|
| ID | Term |
|---|---|
| D005585 | Influenza in Birds |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D001715 | Bird Diseases |
| D000820 | Animal Diseases |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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