Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT06744205
Brief 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.
Detailed Description:
Study details include the following:
* Study Duration: approximately 12 months for each participant
* Treatment: 1 injection of hexavalent vaccine, trivalent vaccine, or active control
* Visit frequency: Day (D) 01, D03, D09, D29, and D181; D366 (telephone call)
* Dose escalation with sequential enrollment of sentinel cohorts followed by parallel enrollment of the main cohort
Study:
NCT06744205
Study Brief:
Protocol Section:
NCT06744205