COVID-19, Influenza,Human
Conditions
Brief summary
This study is to learn about flu and COVID vaccines, either alone or when mixed together. Healthy people aged 18 or older can join. Participants will get one shot in each arm, either a flu or COVID vaccine, alone or mixed. The study lasts about 6 months, and participants need to visit the research site at least 3 times.
Interventions
BIOLOGICALInvestigational Influenza Vaccine
Investigational Influenza Vaccine
BIOLOGICALCOVID-19 Vaccine
Pfizer-BioNTech COVID-19 Vaccine
COMBINATION_PRODUCTInvestigational Influenza/COVID-19 Vaccine
Combined investigational influenza and Pfizer-BioNTech COVID-19 Vaccine
BIOLOGICALLicensed Influenza Vaccine 1
Licensed Influenza Vaccine 1
BIOLOGICALLicensed Influenza Vaccine 2
Licensed Influenza Vaccine 2
OTHERPlacebo
Saline
Sponsors
BioNTech SE
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participants 18 years of age or older * Healthy participants who are determined by medical history, physical examination (if clinically required), and clinical judgment of the investigator to be eligible for inclusion in the study.
Exclusion criteria
* Vaccination with any investigational or licensed 2024-2025 season formulation influenza or COVID-19 vaccine. * Treated with antiviral therapies for influenza (eg, Tamiflu) within 180 days prior to Day 1 Please refer to the study contact for further eligibility details.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 2: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination | From Day 1 through Day 7 after Vaccination [Vaccination on Day 1] | 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. |
| Cohort 1: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination | From Day 1 through Day 7 after Vaccination [Vaccination on Day 1] | 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. |
| Cohort 1: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination | From Day 1 through Day 7 after Vaccination [Vaccination on Day 1] | 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. |
| Cohort 2: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination | From Day 1 through Day 7 after Vaccination [Vaccination on Day 1] | 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. |
| Cohort 1: Percentage of Participants Reporting Adverse Events (AEs) From Vaccination Through 1 Month After Vaccination | From Vaccination on Day 1 through 1 month after Vaccination [Vaccination on Day 1] | 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. |
| Cohort 2: Percentage of Participants Reporting AEs From Vaccination Through 1 Month After Vaccination | From Vaccination on Day 1 through 1 month after Vaccination [Vaccination on Day 1] | 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. |
| Cohort 1: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination | From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1] | 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. |
| Cohort 2: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination | From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1] | 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. |
Countries
United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Participant flow
Recruitment details
There were 2 cohorts in the study: Cohort 1 enrolled participants 18 to 64 years of age and Cohort 2 enrolled participants \>=65 years of age.
Pre-assignment details
Dose strengths for vaccines have not been disclosed in the record, as per Sponsor's decision to maintain company confidentiality; the dose strengths have been denoted as low dose, medium dose and high dose.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized 18-64 years | 699 Participants |
| Age, Customized >=65 years | 648 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 39 Participants |
| Sex: Female, Male Female | 731 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk | EG024 affected / at risk | EG025 affected / at risk | EG026 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 50 | 0 / 49 | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 49 | 0 / 49 | 0 / 51 | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 49 | 1 / 50 | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 49 | 1 / 50 | 0 / 50 | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 34 / 51 | 35 / 50 | 33 / 49 | 43 / 50 | 26 / 50 | 39 / 50 | 41 / 50 | 40 / 50 | 42 / 49 | 45 / 49 | 40 / 51 | 45 / 50 | 40 / 50 | 45 / 50 | 25 / 50 | 31 / 50 | 29 / 49 | 37 / 50 | 29 / 50 | 33 / 50 | 38 / 50 | 35 / 50 | 39 / 49 | 35 / 50 | 39 / 50 | 30 / 50 | 36 / 50 |
| serious Total, serious adverse events | 0 / 51 | 1 / 50 | 0 / 49 | 1 / 50 | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 | 1 / 49 | 0 / 49 | 0 / 51 | 0 / 50 | 0 / 50 | 1 / 50 | 0 / 50 | 0 / 50 | 3 / 49 | 2 / 50 | 0 / 50 | 1 / 50 | 1 / 50 | 0 / 50 | 1 / 49 | 1 / 50 | 0 / 50 | 0 / 50 | 0 / 50 |
Outcome results
None listed