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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021644-18 | EudraCT Number |
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This study will evaluate the safety and immunogenicity of children previously primed in the V70P5 study when revaccinated with adjuvanted or unadjuvanted seasonal influenza vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental |
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| Group 2 | Experimental |
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| Group 3 | Experimental |
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| Group 4 | Experimental |
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| Group 5 | Experimental |
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| Group 6 | Experimental |
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| Group 7 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvanted seasonal influenza vaccine | Biological | Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluate immunogenicity of children primed and revaccinated with adjuvanted influenza vaccine by GMR, seroprotection | 22 days post vaccination | |
| Evaluate immunogenicity of children primed and revaccinated with a half dose of adjuvanted influenza vaccine by GMR, Seroprotection and seroconversion | 22 days post vaccination | |
| Evaluate immunogenicity of children primed with adjuvanted influenza vaccine and revaccinated with unadjuvanted influenza vaccine by GMR, Seroprotection and seroconversion | 22 days post vaccination | |
| Safety and tolerability of a single dose of adjuvanted or unadjuvanted influenza vaccine stratified according to previous influenza vaccine received | 22 days post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Primary immunogenicity outcomes as per CBER criteria | Day 22 | |
| Compare Immunogenicity of each randomization arm by GMT, GMR, seroconversion and seroprotection by Homologous and Heterologous strains | Day 22 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tampere Medical School, Vaccine Research Center / Tampere yliopisto rokotetutkimuskeskus | Biokatu 10, Tampere | FI-33520 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26091244 | Result | Vesikari T, Forsten A, Arora A, Tsai T, Clemens R. Influenza vaccination in children primed with MF59-adjuvanted or non-adjuvanted seasonal influenza vaccine. Hum Vaccin Immunother. 2015;11(8):2102-12. doi: 10.1080/21645515.2015.1044167. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Group 8 |
| Experimental |
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| Group 9 | Experimental |
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| Group 10 | Experimental |
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| Group 11 | Experimental |
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| Group 12 | Experimental |
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| Group 13 | Experimental |
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| Helsinki South, Vaccine Research Clinic, Vuorikatu 18, 3 floor | Helsinki | FI-00100 | Finland |
| Helsinki East, Vaccine Research Clinic, Itäkeskuksen kauppakeskus/Agenttitalo, Turunlinnantie 8, 4.floor | Helsinki | FI-00930 | Finland |
| Järvenpää, Vaccine Research Clinic, Yhteiskouluntie 17 | Jarvenpaa | FI-04400 | Finland |
| Kokkola Vaccine Research Clinic, Rantakatu 7 | Kokkola | FI-67100 | Finland |
| Kotka Vaccine Research Clinic, Karjalantie 10-12 | Kotka | FI-48600 | Finland |
| Kuopio Vaccine Research Clinic, Microkatu 1, N-building, 2nd floor, PL 1188 | Kuopio | 70211 | Finland |
| Lahti Vaccine Research Clinic, Vesijärvenkatu 74 | Lahti | FI-15140 | Finland |
| Oulu Vaccine Research Clinic, Kiviharjunlenkki 6 | Oulu | FI-90220 | Finland |
| Pori Vaccine Research Clinic, Yrjönkatu 23 (4th floor) | Pori | FI-28100 | Finland |
| Seinäjoki Vaccine Research Clinic, Keskuskatu 6 | Seinäjoki | FI-60100 | Finland |
| Tampere Vaccine Research Clinic, Pinninkatu 47 (1. floor) | Tampere | FI-33100 | Finland |
| Espoo Vaccine Research Clinic, Länsituulentie 10, 4th floor | Tapiontori 1, Espoo | FI-02100 | Finland |
| Turku Vaccine Research Clinic, Lemminkäisenkatu 14-18 B (4th floor) | Turku | FI-20520 | Finland |
| Vantaa East, Vaccine Research Clinic, Asematie 11 a 16 | Vantaa | FI-01300 | Finland |
| Vantaa West, Vaccine Research Clinic, Jönsaksentie 6 B, 3rd floor | Vantaa | FI-01600 | Finland |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |