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...
Quadrivalent influenza modRNA vaccine is an investigational vaccine being developed for the prevention of influenza in humans. It is designed to provide protection against four influenza virus strains. The vaccine is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
Quadrivalent influenza modRNA vaccine is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The vaccine is currently in Phase 3 clinical development for the prevention of influenza in adults.
Quadrivalent influenza modRNA vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. A Phase 3 clinical trial has been completed, and the vaccine remains under investigation for the prevention of influenza in adults.
Quadrivalent influenza modRNA vaccine has been studied in a Phase 3 clinical trial identified as NCT05540522, titled 'A Study to Evaluate a Modified RNA Vaccine Against Influenza in Adults 18 Years of Age or Older.' This randomized, double-blind, active-controlled trial enrolled 45,789 participants and has been completed.
Yes, Quadrivalent influenza modRNA vaccine is a modified RNA (modRNA) vaccine. The clinical trial for this vaccine is titled 'A Study to Evaluate a Modified RNA Vaccine Against Influenza in Adults 18 Years of Age or Older,' confirming that the vaccine uses modified RNA technology to target influenza.