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...
mRNA NA vaccine is an investigational vaccine being developed for influenza immunization. It is designed to provide immunity against influenza in adults. The vaccine is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
mRNA NA vaccine is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. The company is conducting clinical trials to evaluate the safety and immunogenicity of this investigational vaccine.
mRNA NA vaccine is in Phase 1 clinical development. It is an investigational vaccine and has not yet received regulatory approval. The Phase 1 trial has been completed, and the vaccine remains in early-stage clinical development.
mRNA NA vaccine has one completed Phase 1 clinical trial, identified as NCT05426174. This study assessed the safety and immunogenicity of the monovalent mRNA NA vaccine in adult participants aged 18 years and older. The trial enrolled 233 participants in the United States.
No, mRNA NA vaccine is not a monoclonal antibody. Although the modality is listed as a monoclonal antibody, the drug name and trial description indicate it is an mRNA-based vaccine. The vaccine is designed for influenza immunization, not as a therapeutic antibody.