Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Investigational Influenza Vaccine · 2 trials · 4 indications
Local reactions included redness, swelling, and pain at the injection site, were recorded in the electronic dairy (e-diary) or case report form (CRF) after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol. Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.
Local reactions included redness, swelling, and pain at the injection site, were recorded in the e-diary or CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol. Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.
Systemic Events: fever, diarrhea, vomiting, headache, fatigue/tiredness, chills, new or worsened muscle pain, and new or worsened joint pain, were recorded in the e-diary or CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol. Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure.
Systemic Events: fever, diarrhea, vomiting, headache, fatigue/tiredness, chills, new or worsened muscle pain, and new or worsened joint pain, were recorded in the e-diary or CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol. Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure.
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. AEs included both serious and all non-serious AEs. Serious AE (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, any other pre-specified criteria in protocol of the study or other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
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. AEs included both serious and all non-serious AEs. 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, any other pre-specified criteria in protocol of the study or other important medical event. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
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, and any other pre-specified criteria in protocol of the study or other important medical event. Only SAEs collected by non-systematic assessment (excluding local reactions and systematic events \[if any\]) were included in this outcome measure.
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, and any other pre-specified criteria in protocol of the study or other important medical event. Only SAEs collected by non-systematic assessment (excluding local reactions and systematic events \[if any\]) were included in this outcome measure.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Low Dose COVID-19 Vaccine (1a) |
| Arm B | EXPERIMENTAL | Low Dose COVID-19 Vaccine ( 1b) |
| Arm C | EXPERIMENTAL | Low Dose COVID-19 Vaccine ( 1c) |
| Arm D | EXPERIMENTAL | Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 1) |
| Arm E | EXPERIMENTAL | Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2) |
| Arm F | EXPERIMENTAL | Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3) |
| Arm G | EXPERIMENTAL | Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4) |
| Arm H | ACTIVE_COMPARATOR | Licensed COVID-19 Vaccine |
| Arm I | ACTIVE_COMPARATOR | Licensed Influenza Vaccine (1) |
| Arm J | EXPERIMENTAL | Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 5) |
| Arm K | EXPERIMENTAL | Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 6) |
| Arm L | EXPERIMENTAL | Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7) |
| Arm M | ACTIVE_COMPARATOR | Licensed COVID-19 Vaccine |
| Arm N | ACTIVE_COMPARATOR | Licensed Influenza Vaccine (2) |
| Arm AA | EXPERIMENTAL | Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 6) |
| Arm BB | EXPERIMENTAL | Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4) |
| Arm CC | EXPERIMENTAL | Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7) |
| Arm DD | EXPERIMENTAL | Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2) |
| Arm EE | EXPERIMENTAL | Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3) |
| Arm FF | ACTIVE_COMPARATOR | Licensed COVID-19 Vaccine |
| Arm GG | ACTIVE_COMPARATOR | Licensed Influenza Vaccine (3) |
| Arm HH | ACTIVE_COMPARATOR | Licensed Influenza Vaccine (2) |
| Arm II | EXPERIMENTAL | Low Dose COVID-19 Vaccine ( 1b) |
| Arm JJ | EXPERIMENTAL | Low Dose COVID-19 Vaccine ( 1c) |
| Arm KK | EXPERIMENTAL | Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 4) |
| Arm LL | EXPERIMENTAL | Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 7) |
| Arm MM | EXPERIMENTAL | Investigational Influenza and COVID-19 Combination Vaccine (Medium Dose Combination 2) |
| Arm NN | EXPERIMENTAL | Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 3) |
| Arm OO | EXPERIMENTAL | Investigational Influenza and COVID-19 Combination Vaccine (High Dose Combination 5) |
| Arm PP | EXPERIMENTAL | Medium Dose Investigational Influenza Vaccine (1) |
| Arm QQ | EXPERIMENTAL | High Dose Investigational Influenza Vaccine (2) |
| Arm RR | ACTIVE_COMPARATOR | Licensed COVID-19 Vaccine |
| Arm SS | ACTIVE_COMPARATOR | Licensed Influenza Vaccine (3) |
| Arm A/AA | EXPERIMENTAL | Low Dose COVID-19 Vaccine and Placebo |
| Arm B/BB | EXPERIMENTAL | Medium Dose COVID-19 Vaccine and Placebo |
| Arm C/CC | ACTIVE_COMPARATOR | High Dose COVID-19 Vaccine and Placebo |
| Arm D/DD | EXPERIMENTAL | Low Dose Investigational Influenza Vaccine and Placebo |
| Arm F/FF | EXPERIMENTAL | Medium Dose Investigational Influenza Vaccine and Placebo |
| Arm G/GG | EXPERIMENTAL | Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo |
| Arm H/HH | EXPERIMENTAL | Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine and Placebo |
| Arm I/II | EXPERIMENTAL | Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo |
| Arm J/JJ | EXPERIMENTAL | High Dose Investigational Influenza Vaccine and Placebo |
| Arm K/KK | EXPERIMENTAL | Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo |
| Arm L/LL | EXPERIMENTAL | Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine and Placebo |
| Arm M/MM | EXPERIMENTAL | High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine and Placebo |
| Name | Type | Description |
|---|---|---|
| Investigational Influenza Vaccine | BIOLOGICAL | Investigational Influenza Vaccine |
| Investigational COVID-19 Vaccine | BIOLOGICAL | Investigational COVID-19 Vaccine |
| Investigational Influenza and COVID-19 Combination Vaccine | COMBINATION_PRODUCT | Investigational Combined Influenza and COVID-19 Vaccine |
| Licensed Influenza Vaccine 1 | BIOLOGICAL | Licensed Influenza Vaccine 1 |
| Licensed Influenza Vaccine 2 | BIOLOGICAL | Licensed Influenza Vaccine 2 |
| Licensed Influenza Vaccine 3 | BIOLOGICAL | Licensed Influenza Vaccine 3 |
| Licensed COVID-19 Vaccine | BIOLOGICAL | Pfizer-BioNTech COVID-19 Vaccine |
| COVID-19 Vaccine | BIOLOGICAL | Pfizer-BioNTech COVID-19 Vaccine |
| Investigational Influenza/COVID-19 Vaccine | COMBINATION_PRODUCT | Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine |
| Placebo | OTHER | Saline |
Inclusion criteria: * Participants 18 years of age or older * Healthy participants who are determined by medical history, physical examination (if clinically required), and clinical judgement of the investigator to be eligible for inclusion in the study Exclusion criteria: * Vaccination with any ...
The Investigational Influenza Vaccine is a Phase 1 investigational vaccine being developed by BioNTech SE (BNTX) for influenza in humans. It is being studied in healthy adults aged 18 years and older in the United States. The vaccine is not yet approved and remains in clinical development.
The Investigational Influenza Vaccine targets influenza viruses. It is being studied for its ability to generate immune responses against flu, as well as COVID-19 when given alongside COVID-19 vaccines. The exact molecular target has not been specified in available information.
The Investigational Influenza Vaccine is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker BNTX. BioNTech is conducting Phase 1 clinical trials of the vaccine in the United States.
The Investigational Influenza Vaccine is in Phase 1 clinical development. It is an investigational product and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, with a total enrollment of 2,650 healthy participants.
The Investigational Influenza Vaccine has been studied in two completed Phase 1 trials: NCT06683352, which enrolled 1,353 healthy adults, and NCT06821061, which enrolled 2,650 healthy adults. Both trials were conducted in the United States and evaluated flu and COVID-19 vaccine responses in healthy people aged 18 and older.
The Investigational Influenza Vaccine is not the same as a COVID-19 vaccine. It is designed to target influenza, but clinical trials are evaluating it alongside COVID-19 vaccines to study immune responses to both flu and COVID-19 in healthy adults.