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The purpose of this study is to assess the safety and immunogenicity (i.e. primary immune response, immunogenicity of two different doses, antibody persistence 360 days after the first vaccination, immune response to a heterologous booster given on Day 360) of a Vero cell-derived whole virus H5N1 influenza vaccine in healthy infants, children and adolescents aged 6 months to 17 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose A | Experimental | Two intramuscular injections (21 days apart, i.e. Days 0 and 21) of H5N1 Influenza Vaccine (Dose A) followed by a heterologous booster vaccination (Dose A) on Day 360 |
|
| Dose B | Experimental | Two intramuscular injections (21 days apart, i.e. Days 0 and 21) of H5N1 Influenza Vaccine (Dose B) followed by a heterologous booster vaccination (Dose B) on Day 360 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation | Biological | Two vaccinations, 21 days apart, followed by a heterologous booster vaccination on Day 360 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of systemic reactions until 7 days after the first vaccination | 7 days | |
| Rate of subjects with antibody response to the vaccine strain associated with protection 21 days after the second vaccination defined as titer measured by Microneutralization test >= 1:20. | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of systemic and injection site reactions until 21 days after the first, second and booster vaccination | Day 21, 42 and 381 | |
| Fever, malaise or shivering (in children and adolescents aged 3 to 17 years) and fever and irritability (in infants and young children aged 6 to 35 months) with onset within 7 days after the first, second and booster vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| BioScience Investigator, MD | Baxter Innovations GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Hospital for Children | Subiaco | 6008 | Australia | |||
| Tampere University, Espoo Vaccine Research (Tampereen Yliopisto, Espoon Rokotetutkimus) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24041789 | Derived | van der Velden MV, Fritz R, Pollabauer EM, Portsmouth D, Howard MK, Kreil TR, Dvorak T, Fritsch S, Vesikari T, Diez-Domingo J, Richmond P, Lee BW, Kistner O, Ehrlich HJ, Barrett PN, Aichinger G. Safety and immunogenicity of a vero cell culture-derived whole-virus influenza A(H5N1) vaccine in a pediatric population. J Infect Dis. 2014 Jan 1;209(1):12-23. doi: 10.1093/infdis/jit498. Epub 2013 Sep 16. |
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| Day 21, 42 and 381 |
| Adverse events observed during the entire study period | Throughout entire study period |
| Antibody response associated with protection 21 days after the first and second vaccination, and again at 360 days after the first vaccination and 21 days after the booster vaccination | Antibody response defined as Hemagglutination Inhibition Antibody (HIA) titer >= 1:40 or Single Radial Hemolysis (SRH) area >= 25 mm2, and as measured by Microneutralization (MN) test >= 1:20 | Day 21, 42, 360 and 381 |
| Fold increase of antibody response 21 days after first and second vaccination as compared to baseline, and again at 21 days after the booster vaccination as compared to before the booster vaccination | Measured by MN, HI and SRH assay | Day 21, 42, 360 and 381 |
| Seroconversion 21 days after the first and second vaccination and at 21 days after the booster vaccination | Measured by MN, HI and SRH assay | Day 21, 42 and 381 |
| Espoo |
| 02100 |
| Finland |
| South Helsinki Vaccine Research Clinic (Etelä-Helsingin Rokotetutkimusklinikka) | Helsinki | 00100 | Finland |
| Kokkola Vaccine Research Clinic (Kokkolan Rokotetutkimusklinikka) | Kokkola | 67100 | Finland |
| Kuopion Vaccine Research Clinic | Kuopio | 70210 | Finland |
| Oulu Vacine Research Clinic (Oulun Rokotetutkimusklinikka) | Oulu | 90220 | Finland |
| Porin Vaccine Research Clinic | Pori | 28100 | Finland |
| University of Tampere, Seinäjoki Vaccine Research Clinic (Tampereen Yliopisto, Seinajoen Rokotetutkimusklinikka) | Seinäjoki | 60100 | Finland |
| Tampere Vacine Research Clinic (Tampereen Rokotetutkimusklinikka) | Tampere | 33100 | Finland |
| Turku Vaccine Research Clinic (Turun Rokotetutkimusklinikka) | Turku | 20520 | Finland |
| University of Tampere, Vantaa East Vaccine Research Clinic (Itä Vantaan Rokotetutkimusklinikka) | Vantaa | 01300 | Finland |
| The Children´s Medical Institute | Singapore | 119074 | Singapore |
| Mount Elizabeth Medical Centre, The Child and Allergy Clinic | Singapore | 228510 | Singapore |
| Centro de Salud de Paiporta | Paiporta | 46200 | Spain |
| Instituto Hispalense de Pediatria, Pediatría - IHP1 | Seville | 41013 | Spain |
| Centro de Salud Malvarrosa | Valencia | 46011 | Spain |
| Centro de Salud Serreria II | Valencia | 46022 | Spain |
| Centro de Salud Trafalgar | Valencia | 46023 | Spain |
| Centro de Salud de Catarroja | Valencia | 46470 | Spain |
| Centro de Salud Quart de Poblet | Valencia | 46930 | Spain |
| ID | Term |
|---|---|
| D005585 | Influenza in Birds |
| ID | Term |
|---|---|
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D001715 | Bird Diseases |
| D000820 | Animal Diseases |
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