drugset / Trial / NCT06744205
A Study on the Safety and Immunogenicity of Hexavalent Influenza mRNA Vaccine in Adult Participants 50 Years of Age and Older
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular injection of different formulations of a hexavalent influenza messenger ribonucleic acid (mRNA) vaccine composed of differing dose levels of trivalent (TIV) mRNA hemagglutinin (HA) in combination with TIV mRNA-neuraminidase (NA) compared to an active control ((Fluzone standard-dose quadrivalent influenza vaccine (QIV-SD) or Fluzone high-dose quadrivalent influenza vaccine (QIV-HD) in adults 50 years of age and older.
Timeline
- Start
- 2025-01-06
- Primary completion
- 2026-05-22
- Completion
- 2026-05-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Quadrivalent Influenza Standard Dose Vaccine | Vaccine | — | Intramuscular |
| Comparator | Quadrivalent Influenza Vaccine High Dose | Vaccine | — | Intramuscular |
| Subject | TIV mRNA-HA Vaccine 2 | Messenger RNA (mRNA) | — | Intramuscular |
| Subject | TIV mRNA-neuraminidase (NA) | Messenger RNA (mRNA) | — | Intramuscular |
| Subject | Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1 | Messenger RNA (mRNA) | — | Intramuscular |