Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Quadrivalent influenza modRNA vaccine · 1 trial · 1 indication
LCI was defined as influenza infection confirmed through through reverse transcription- polymerase chain reaction (RT-PCR) or culture at the central laboratory, unless otherwise specified. Per-protocol ILI was defined as occurrence (new onset or worsening of preexisting condition) of at least 1 respiratory symptoms concurrently with at least 1 systemic symptoms. Data was obtained during the 2022-2023 northern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
LCI was defined as influenza infection confirmed through RT-PCR or culture at the central laboratory, unless otherwise specified. Per-protocol ILI was defined as occurrence (new onset or worsening of preexisting condition) of at least 1 respiratory symptoms concurrently with at least 1 systemic symptoms. Data was obtained during the 2022-2023 northern and southern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Local reactions included redness, swelling and pain at the injection site and were recorded by participants in an e-diary. All local reactions were graded based on Center for Biologics Evaluation and Research (CBER) toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure data is reported for any local reaction and any grade.
Local reactions included redness, swelling and pain at the injection site and were recorded by participants in an e-diary. All local reactions were graded based on Center for Biologics Evaluation and Research (CBER) toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure data is reported for any local reaction and any grade.
Systemic events (vomiting, diarrhoea, headache, Fatigue/tiredness, chills, new or worsened muscle pain and joint pain) were recorded by participants in an e-diary. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure data is reported for any systemic reaction and any grade.
Systemic events (vomiting, diarrhoea, headache, Fatigue/tiredness, chills, new or worsened muscle pain and joint pain) were recorded by participants in an e-diary. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure data is reported for any systemic reaction and any grade.
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data.
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data.
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data.
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect.
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect.
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect.
| Arm | Type | Description |
|---|---|---|
| Quadrivalent influenza modRNA vaccine, 18 through 64 years of age | EXPERIMENTAL | Quadrivalent influenza modRNA vaccine (single dose), participants 18 through 64 years of age |
| Quadrivalent influenza vaccine, 18 through 64 years of age | ACTIVE_COMPARATOR | Licensed quadrivalent influenza vaccine (single dose), participants 18 through 64 years of age |
| Quadrivalent influenza modRNA vaccine, ≥65 years of age | EXPERIMENTAL | Quadrivalent influenza modRNA vaccine (single dose), participants ≥65 years of age |
| Quadrivalent influenza vaccine, ≥65 years of age | ACTIVE_COMPARATOR | Licensed quadrivalent influenza vaccine (single dose), participants ≥65 years of age |
| Name | Type | Description |
|---|---|---|
| Quadrivalent influenza modRNA vaccine | BIOLOGICAL | Quadrivalent influenza modRNA vaccine (single dose) |
| Quadrivalent influenza vaccine | BIOLOGICAL | Licensed quadrivalent influenza vaccine (single dose) |
Inclusion Criteria: 1. Male or female participants ≥18 years of age at Visit 1 (Day 1). 2. Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures. 3. Healthy participants who are determi...
The quadrivalent influenza modRNA vaccine is an investigational vaccine developed by Pfizer, Inc. (NYSE: PFE) for the prevention of influenza in humans. It uses modified RNA (modRNA) technology and is designed to target four influenza virus strains, hence quadrivalent. It is currently in Phase 3 clinical development.
The quadrivalent influenza modRNA vaccine is being developed for the prevention of influenza in adults 18 years of age and older. It is intended to protect against four different influenza virus strains. The vaccine is investigational and has not been approved for use.
Pfizer, Inc. (NYSE: PFE) is developing the quadrivalent influenza modRNA vaccine. Pfizer is the sponsor of the clinical trial evaluating this vaccine candidate.
The quadrivalent influenza modRNA vaccine is in Phase 3 clinical development. A Phase 3 trial has been completed, but the vaccine is still investigational and has not been approved by the FDA or any regulatory agency.
The quadrivalent influenza modRNA vaccine has been evaluated in a Phase 3 clinical trial, NCT05540522, titled "A Study to Evaluate a Modified RNA Vaccine Against Influenza in Adults 18 Years of Age or Older." The trial enrolled 45,789 participants and has been completed.
The quadrivalent influenza modRNA vaccine uses modified RNA (modRNA) technology to induce an immune response against influenza. It is designed to target four influenza virus strains. The vaccine is administered to adults 18 years and older.