A Study to Learn About a Combined COVID-19 and Influenza Shot in Healthy Adults : A Phase 1/2 Randomized Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Modified RNA COVID-19 Vaccine and a Recombinant Influenza Vaccine Administered as a Single Injection in Healthy Adults 50 Years of Age or Older
This is a Phase 1/2 study to evaluate the safety, tolerability, and immunogenicity of licensed BNT162b2 (Omi XBB.1.5) and recombinant influenza vaccine (RIV) administered together as a single injection (referred to as BNT162b2 [Omi XBB.1.5]/RIV) in healthy adults 50 years of age or older.The safety, tolerability, and immunogenicity of BNT162b2 (OmiXBB1.5)/RIV administered as a single injection will be compared to BNT162b2 (Omi XBB.1.5) and RIV administered simultaneously as 2 separate injections (coadministered), and to BNT162b2 (Omi XBB.1.5) or RIV when administered alone.Across Phases 1 and 2, approximately 640 participants in total will be randomized with an equal randomization ratio to 1 of 4 vaccine groups and stratified by age..
| Medienart: |
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Klinische Studie| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 26. März Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
610 |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: February 1, 2024, Last downloaded: ClinicalTrials.gov processed this data on April 03, 2024, Last updated: April 03, 2024 |
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| Study ID: |
NCT06237049 |
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| Veröffentlichungen zur Studie: |
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| PPN (Katalog-ID): |
CTG000050539 |
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| 245 | 1 | 0 | |a A Study to Learn About a Combined COVID-19 and Influenza Shot in Healthy Adults |b A Phase 1/2 Randomized Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Modified RNA COVID-19 Vaccine and a Recombinant Influenza Vaccine Administered as a Single Injection in Healthy Adults 50 Years of Age or Older |
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| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: February 1, 2024, Last downloaded: ClinicalTrials.gov processed this data on April 03, 2024, Last updated: April 03, 2024 | ||
| 520 | |a This is a Phase 1/2 study to evaluate the safety, tolerability, and immunogenicity of licensed BNT162b2 (Omi XBB.1.5) and recombinant influenza vaccine (RIV) administered together as a single injection (referred to as BNT162b2 [Omi XBB.1.5]/RIV) in healthy adults 50 years of age or older.The safety, tolerability, and immunogenicity of BNT162b2 (OmiXBB1.5)/RIV administered as a single injection will be compared to BNT162b2 (Omi XBB.1.5) and RIV administered simultaneously as 2 separate injections (coadministered), and to BNT162b2 (Omi XBB.1.5) or RIV when administered alone.Across Phases 1 and 2, approximately 640 participants in total will be randomized with an equal randomization ratio to 1 of 4 vaccine groups and stratified by age. | ||
| 650 | 2 | |a COVID-19 | |
| 650 | 2 | |a Influenza, Human | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Active, not recruiting | |
| 650 | 4 | |a Phase: Phase 2 | |
| 650 | 4 | |a 610 | |
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