Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Quadrivalent Influenza mRNA Vaccine MRT5421 · 1 trial · 2 indications
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form in terms of diagnosis and onset window post-vaccination. Systemic AEs are all AEs that were not injection or administration site reactions. Immediate events are recorded to capture medically relevant unsolicited systemic AEs which occur within the first 30 minutes after vaccination.
An adverse reaction (AR) is any noxious and unintended response to a study vaccine related to any dose. Solicited injection site reactions are reactions at and around the injection site of the vaccine observed and reported under the conditions (nature and onset) pre-listed in the protocol and case report form.
An AR is any noxious and unintended response to a study vaccine related to any dose. Solicited systemic reactions are systemic AEs observed and reported under the conditions (nature and onset) pre-listed in the protocol and case report form.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form in terms of diagnosis and onset window post-vaccination.
An MAAE is a new onset or a worsening of a condition that prompts the participant or participant's parent/legally acceptable representative to seek unplanned medical advice at a physician's office or emergency department.
An SAE is any untoward medical occurrence that at any dose results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or is an important medical event. An AESI (serious or non-serious) is 1 of scientific and medical concern specific to the Sponsor's study vaccine or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor can be appropriate. The AESIs was defined as anaphylactic reactions (including bronchospasms, and laryngeal spasms), Guillain-Barré syndrome, neuritis (including Bell's palsy), myocarditis, pericarditis, myopericarditis and vasculitis.
Blood samples were collected for the assessment of abnormal hematology and clinical chemistry parameters. Only participants with outside the normal range hematology and clinical chemistry parameters are reported.
The HAI Ab was measured by hemagglutinin inhibition using quality control sera (sheep, ferret and/or human sera) measurement method. The 95% confidence interval (CI) was based on the Clopper-Pearson method.
The HAI Ab was measured by hemagglutinin inhibition using quality control sera (sheep, ferret and/or human sera) measurement method. The 95% CI was based on the Clopper-Pearson method.
The HAI Ab was measured by hemagglutinin inhibition using quality control sera (sheep, ferret and/or human sera) measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
The HAI Ab was measured by hemagglutinin inhibition using quality control sera (sheep, ferret and/or human sera) measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
The HAI Ab was measured by hemagglutinin inhibition using quality control sera (sheep, ferret and/or human sera) measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Clopper-Pearson method.
The seroconversion was defined as titer \<10 on Day 1 and post-injection titer \>=40 on Day 29; or defined as titer \>=10 on Day 1 and a \>=4-fold increase in titer on Day 29. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
The HAI Ab was measured by hemagglutinin inhibition using quality control sera (sheep, ferret and/or human sera) measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
The HAI Ab was measured by hemagglutinin inhibition using quality control sera (sheep, ferret and/or human sera) measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
| Arm | Type | Description |
|---|---|---|
| Quadrivalent Influenza mRNA Vaccine MRT5421 Dose 1 | EXPERIMENTAL | participants received a single dose of QIV mRNA vaccine MRT5421 |
| Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 1 | EXPERIMENTAL | participants received a single dose of QIV mRNA vaccine MRT5429 |
| Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 2 | EXPERIMENTAL | participants received a single dose of QIV mRNA vaccine MRT5429 |
| Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 3 | EXPERIMENTAL | participants received a single dose of QIV mRNA vaccine MRT5429 |
| Quadrivalent Influenza mRNA Vaccine MRT5429 Dose 4 | EXPERIMENTAL | participants received a single dose of QIV mRNA vaccine MRT5429 |
| Quadrivalent Influenza mRNA Vaccine MRT5424 Dose 1 | EXPERIMENTAL | participants received a single dose of QIV mRNA vaccine MRT5424 |
| Quadrivalent Influenza mRNA Vaccine MRT5424 Dose 2 | EXPERIMENTAL | participants received a single dose of QIV mRNA vaccine MRT5424 |
| Quadrivalent Influenza SD Vaccine | ACTIVE_COMPARATOR | participants received a single dose of QIV-SD vaccine |
| Quadrivalent Influenza HD Vaccine | ACTIVE_COMPARATOR | participants received a single dose of QIV -HD vaccine (for adults ≥ 65 years of age only) |
| Quadrivalent Influenza RIV4 Vaccine | ACTIVE_COMPARATOR | participants received a single dose of RIV4 vaccine |
| Name | Type | Description |
|---|---|---|
| Quadrivalent Influenza mRNA Vaccine MRT5421 | BIOLOGICAL | Pharmaceutical form:solution in a vial-Route of administration:Intramuscular injection |
| Quadrivalent Influenza mRNA Vaccine MRT5424 | BIOLOGICAL | Pharmaceutical form:solution in a vial-Route of administration:Intramuscular injection |
| Quadrivalent Influenza mRNA Vaccine MRT5429 | BIOLOGICAL | Pharmaceutical form:solution in a vial-Route of administration:Intramuscular Injection |
| Quadrivalent Influenza Standard Dose Vaccine | BIOLOGICAL | Pharmaceutical form: suspension for injection in prefilled syringe -Route of administration:Intramuscular injection |
| Quadrivalent Influenza High-Dose Vaccine | BIOLOGICAL | Pharmaceutical form:suspension for injection in pre filled syringe -Route of administration:Intramuscular injection |
| Quadrivalent Recombinant Influenza Vaccine | BIOLOGICAL | Pharmaceutical form:suspension for injection in pre filled syringe-Route of administration:Intramuscular injection |
Inclusion Criteria: * Aged from 18 years on the day of inclusion or aged from 21 years on the days of inclusion, depending on the countries. * A female participant was eligible to participate if she was not pregnant or breastfeeding and one of the following conditions applied: * Was of non-child...
MRT5421 is an investigational quadrivalent influenza mRNA vaccine developed by Sanofi for influenza immunization. It is designed to protect against influenza and has been studied in healthy adults aged 18 years and above. It is a vaccine candidate and remains in clinical development.
MRT5421 is being developed for influenza immunization in adults. Its Phase 1 study enrolled healthy volunteers aged 18 years and above to evaluate the vaccine for protection against influenza. The program targets the infectious disease therapeutic area.
Sanofi is developing MRT5421, the quadrivalent influenza mRNA vaccine. Sanofi trades on the New York Stock Exchange under the ticker SNY. The company is the sponsor of the Phase 1 trial evaluating the vaccine candidate.
MRT5421 is in Phase 1 clinical development. Its single Phase 1 trial has completed, and no active trials are currently listed for the program. The vaccine candidate is investigational and has not been approved for use.
MRT5421 has been evaluated in one Phase 1 trial, NCT06361875, titled A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above. The completed trial enrolled 908 participants across the United States, Honduras, and Puerto Rico.
The Phase 1 trial NCT06361875 was a randomized, double-blind, active-controlled study of the quadrivalent influenza mRNA vaccine in healthy adults aged 18 years and above. It enrolled 908 participants across sites in the United States, Honduras, and Puerto Rico and has completed.