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 ...
Top 8 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | mRNA Seasonal Flu vaccine, Flu/COVID-19 mRNA combination vaccine |
| Sinovac Biotech Ltd. | SVA | 1 | PHASE3 | Quadrivalent influenza vaccine (split virion), inactivated |
| Moderna, Inc. | MRNA | 2 | PHASE3 | mRNA-1018-H5, mRNA-1010, Fluarix Trivalent |
| Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | CDTX | 1 | PHASE3 | CD388 |
| Traws Pharma, Inc. | TRAW | 2 | PHASE2 | TRX-100 |
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE1 | H5N8 pandemic influenza vaccine (adjuvanted) |
| Hoffmann-La Roche | RHHBY | 2 | PHASE3 | Baloxavir Marboxil |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD4117, AZD5315 |
It is a Phase 1 vaccine candidate being developed by BioNTech SE for the prevention of influenza in humans. It is an investigational product and has not been approved for use. BioNTech is studying it in healthy adult volunteers as part of its infectious disease vaccine program.
It is being studied for the prevention of influenza, including human influenza infection, in healthy adults. The clinical program has also evaluated it alongside a COVID-19 vaccine candidate. Because it remains investigational, it is not currently available as a licensed product for preventing flu.
BioNTech SE, which trades on Nasdaq under the ticker BNTX, is the developer of this investigational influenza vaccine. The company is running the clinical program in the United States, with study sites enrolling healthy adult volunteers aged 18 years and older.
The BioNTech investigational influenza vaccine is in Phase 1 clinical development. Its Phase 1 studies have been completed, and the candidate remains investigational rather than approved. No Phase 2 or later stage trial for this vaccine is listed in the current development record.
Two completed Phase 1 trials are listed: NCT06821061, titled A Study to Learn About How the Flu and COVID-19 Vaccines Act in Healthy People, and NCT06683352, titled A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy People. Both were conducted in the United States in healthy adults.
The trials were randomized, double-blind, and actively controlled, enrolling healthy volunteers aged 18 years and older of any sex. NCT06821061 enrolled 2,650 participants and NCT06683352 enrolled 1,353 participants. Both studies evaluated influenza and COVID-19 vaccine responses and have been completed.