Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
mRNA NA vaccine · 1 trial · 2 indications
Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination
Unsolicited (spontaneously reported) adverse events not fulfilling criteria for solicited reactions
Serious adverse events are collected throughout the study
Adverse events of special interest are collected throughout the study
Laboratory tests include hematology: complete blood count (CBC) with differential, platelet count, coagulation panel (prothrombin time and PTT) and serum chemistry: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total and fractionated bilirubin, C-reactive protein, serum creatinine, and blood urea nitrogen
| Arm | Type | Description |
|---|---|---|
| Group 1 mRNA NA: Low dose Level | EXPERIMENTAL | Participants will receive a low dose of mRNA vaccine |
| Group 2 mRNA NA: Medium dose level | EXPERIMENTAL | Participants will receive a medium dose of mRNA vaccine |
| Group 3 mRNA NA: High dose level | EXPERIMENTAL | Participants will receive a high dose of mRNA vaccine |
| Group 4: QIV-HD | ACTIVE_COMPARATOR | Participants will receive QIV-HD (high dose quadrivalent influenza) vaccine |
| Name | Type | Description |
|---|---|---|
| mRNA NA vaccine | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
| High Dose Quadrivalent Influenza Vaccine | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
Inclusion Criteria: * Aged 18 years or older on the day of inclusion. * A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: 1. Is of non-childbearing potential. To be considered of non-childbearing potential, a fema...
The mRNA NA vaccine is an investigational vaccine developed by Sanofi for influenza immunization. It uses messenger RNA to present the neuraminidase antigen, aiming to protect against influenza. It is in Phase 1 clinical development and has been studied in a completed trial of 233 adults aged 18 and older.
The mRNA NA vaccine is being developed for influenza immunization. It is intended to prevent influenza infection in healthy adults. The vaccine is investigational and has been evaluated in a Phase 1 trial that enrolled 233 participants aged 18 years and older in the United States.
Sanofi develops the mRNA NA vaccine. Sanofi is a global pharmaceutical company traded on the New York Stock Exchange under the ticker SNY. The company is responsible for the research and clinical development of this investigational influenza vaccine candidate.
The mRNA NA vaccine is in Phase 1 clinical development. One Phase 1 trial has been completed. The vaccine is investigational and has not been approved by the FDA for any indication. The completed trial enrolled 233 adults and assessed safety and immunogenicity.
The mRNA NA vaccine has been studied in one completed Phase 1 trial, NCT05426174, titled "Study to Assess the Safety and Immunogenicity of Monovalent mRNA NA Vaccine in Adult Participants 18 Years of Age and Older." It was a randomized, double-blind, active-controlled trial that enrolled 233 participants in the United States.