Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Licensed COVID-19 Vaccine
COVID-19 Vaccine · 1 trial · 2 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.
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 including fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain were recorded in an 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 including fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain were recorded in an 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 including fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and new or worsened joint pain were recorded in an 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.
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.
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.
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.
GMTs and the corresponding 2-sided confidence interval (CIs) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the lower limit of quantitation (LLOQ) were set to 0.5 \*LLOQ. GMTs were reported in the descriptive data section of this outcome measure. GMRs were reported in the statistical analysis section. Data was reported for the following strains: H1N1, H3N2 and Victoria.
Seroconversion was defined as having an HAI titer \<1:10 prior to vaccination and greater than or equal to (\>=) 1:40 at the postvaccination time point of interest, or an HAI titer of \>=1:10 prior to vaccination with a minimum 4-fold rise at the postvaccination time point of interest. Percentage of participants with seroconversion were reported in the descriptive data section of this outcome measure. Difference in percentage of participants with seroconversion were reported in the statistical analysis section. Data was reported for the following strains: H1N1, H3N2 and Victoria.
GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 \*LLOQ. GMTs were reported in the descriptive data section of this outcome measure. GMRs were reported in the statistical analysis section.
Seroresponse was defined as achieving a postvaccination \>=4-fold rise from baseline (before the study vaccination). If the baseline measurement was below the LLOQ, the postvaccination measure of \>=4\*LLOQ was considered seroresponse. Percentage of participants with seroresponse were reported in the descriptive data section of this outcome measure. Difference in percentage of participants with seroresponse were reported in the statistical analysis section.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 Arm A: Influenza and COVID-19 Combination A and Placebo | EXPERIMENTAL | Cohort 1 Arm A: Influenza and COVID-19 combination A vaccine and Placebo |
| Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group | ACTIVE_COMPARATOR | Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group |
| Cohort 2 Arm C:Influenza and COVID-19 Combination B and Placebo | EXPERIMENTAL | Cohort 2 Arm C: Influenza and COVID-19 Combination B vaccine and Placebo |
| Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group | ACTIVE_COMPARATOR | Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group |
| Cohort 3 Arm E:Influenza and COVID-19 Combination B | EXPERIMENTAL | Cohort 3 Arm E:Influenza and COVID-19 Combination B |
| Cohort 3 Arm F: COVID-19 vaccine | ACTIVE_COMPARATOR | Cohort 3 Arm F: COVID-19 vaccine |
| Cohort 3 Arm G: Licensed influenza vaccine | ACTIVE_COMPARATOR | Cohort 3 Arm G: Licensed influenza vaccine |
| Cohort 3 Arm H: Investigational influenza vaccine | ACTIVE_COMPARATOR | Cohort 3 Arm H: Investigational influenza vaccine |
| Name | Type | Description |
|---|---|---|
| Influenza and COVID-19 Combination A | BIOLOGICAL | Combined influenza and Pfizer-BioNTech COVID-19 Vaccine |
| Licensed influenza vaccine | BIOLOGICAL | Licensed influenza vaccine |
| COVID-19 Vaccine | BIOLOGICAL | Pfizer-BioNTech COVID-19 vaccine |
| Influenza and COVID-19 Combination B | BIOLOGICAL | Combined influenza and Pfizer-BioNTech COVID-19 vaccine |
| Placebo | BIOLOGICAL | Saline Solution |
| Investigational influenza vaccine | BIOLOGICAL | Investigational influenza vaccine |
Inclusion Criteria: * Participants 18 through 64 years of age (or the minimum age of consent in accordance with local regulations) at Visit 1. * Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible f...
Top 8 of 11 competitors
The COVID-19 Vaccine is a modified RNA vaccine candidate developed by BioNTech SE. It is designed as a combined vaccine against COVID-19 and influenza. It is also known as the Licensed COVID-19 Vaccine. The vaccine is in Phase 3 clinical development and has been studied in a completed trial.
The COVID-19 Vaccine is being developed for immunization against COVID-19 and influenza. It is intended to prevent these infectious diseases. The vaccine is not yet approved and remains investigational.
The COVID-19 Vaccine is developed by BioNTech SE, which trades under the ticker symbol BNTX. BioNTech is responsible for the research and development of this combined modified RNA vaccine candidate.
The COVID-19 Vaccine is in Phase 3 clinical development. A Phase 3 trial has been completed. The vaccine is investigational and has not been approved by the FDA.
The COVID-19 Vaccine has been evaluated in a Phase 3 clinical trial, NCT06178991. This completed trial studied the safety, tolerability, and immunogenicity of the combined modified RNA vaccine candidate against COVID-19 and influenza. It enrolled 8,795 participants in the United States.
Yes, the COVID-19 Vaccine is also known as the Licensed COVID-19 Vaccine. Both names refer to the same combined modified RNA vaccine candidate developed by BioNTech SE for COVID-19 and influenza.