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valneva_vla2001 [2021/12/09 19:29]
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| * December 8, 2021: Valneva [[https://valneva.com/press-release/valneva-signs-advance-purchase-agreement-with-bahrain-for-inactivated-covid-19-vaccine-vla2001/|signs]] advance purchase agreement with Bahrain for 1 million doses | * December 8, 2021: Valneva [[https://valneva.com/press-release/valneva-signs-advance-purchase-agreement-with-bahrain-for-inactivated-covid-19-vaccine-vla2001/|signs]] advance purchase agreement with Bahrain for 1 million doses |
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| == Clinical Trials == | == Clinical Trials Summary == |
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| | | Participants | Covid + | # of Solicited Severe Adverse Events Reported | # of Vax Related Serious Adverse Events | | | | Participants | Covid+ | Total Adverse Events | # of Solicited Severe Adverse Events Reported | # of Vax Related Serious Adverse Events | Observed AE's | |
| |Phase 1/2| 153 | ? | 2 | 0 | | |Phase1/2| 153 | 2 | 106 | 2 | 0 | pain, tenderness, erythema, induration/swelling, nausea/vomiting, headache, fatigue, myalgia, neutropenia, eosinophilia, thrombocytopenia, chilblains, haematuria, rise in red blood cell/erythrocyte sedimentation rate | |
| |Phase 3 | 4,012 | ? | ? | 0 | | |Phase3 | 4,012 | ? | ? | 0 | |
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| | == Published Clinical Trial Results == |
| | [[https://www.medrxiv.org/content/10.1101/2021.08.13.21262021v2|NCT04671017: Immunogenicity and safety of inactivated whole virion Coronavirus vaccine with CpG (VLA2001) in healthy adults aged 18 to 55: a randomised phase 1 /2 clinical trial]] |
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| NCT04671017 Dose Finding Study to Evaluate Safety, Tolerability and Immunogenicity of an Inactiviated Adjuvanted Sars-Cov-2 Virus Vaccine Candidate Against Covid-19 in Healthy Adults. \\ | {{https://www.medrxiv.org/content/medrxiv/early/2021/08/20/2021.08.13.21262021/T3.medium.gif}} |
| NCT04864561 Study To Compare The Immunogenicity Against COVID-19, Of VLA2001 Vaccine To AZD1222 Vaccine (COV-COMPARE). \\ | |
| NCT04956224 Immunogenicity of VLA2101 Compared to VLA2001. \\ | |
| | == Registered Clinical Trials == |
| | NCT04671017 Dose Finding Study to Evaluate Safety, Tolerability and Immunogenicity of an Inactiviated Adjuvanted Sars-Cov-2 Virus Vaccine Candidate Against Covid-19 in Healthy Adults. |
| | NCT04864561 Study To Compare The Immunogenicity Against COVID-19, Of VLA2001 Vaccine To AZD1222 Vaccine (COV-COMPARE). |
| | NCT04956224 Immunogenicity of VLA2101 Compared to VLA2001. |
