A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy People
- 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.
- Short title
- A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy People
- Official title
- A PHASE 1/2, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF COMBINED VACCINE CANDIDATES AGAINST INFLUENZA AND COVID-19 IN HEALTHY INDIVIDUALS
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1/Phase 2
- Study type
- Interventional
- Completion date
- 2025-07-15
- First posted
- 2024-11-12
- Registry last updated
- 2026-08-19
- Primary completion date
- 2025-07-15
- Start date
- 2024-11-11
- Actual participants
- 1,353
- Participants
- 1,353
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- BioNTech SE
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06683352
- ClinicalTrials.gov ID
- NCT06683352
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Cohort 1: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination
Timeframe: 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 2: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination
Timeframe: 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 Systemic Events for up to 7 Days Following Vaccination
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- Yes
- 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.
- 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.
- Orange County Research CenterLake Forest, United States
- Artemis Institute for Clinical ResearchSan Diego, United States
- Diablo Clinical Research, Inc.Walnut Creek, United States
- Clinical Research ConsultingMilford, United States
- Indago Research & Health Center, IncHialeah, United States
- Miami Dade Medical Research Institute, LLCMiami, United States
- Palm Springs Community Health CenterMiami Lakes, United States
- Headlands Research OrlandoOrlando, United States
- Clinical Research AtlantaStockbridge, United States
- East-West Medical Research InstituteHonolulu, United States
- Clinical Research ProfessionalsChesterfield, United States
- Bio-Kinetic Clinical Applications, LLC dba QPS-MOSpringfield, United States
- Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment CenterSpringfield, United States
- Velocity Clinical Research, OmahaOmaha, United States
- Las Vegas Clinical TrialsLas Vegas, United States
- ActivMed Practices & Research, LLC.Portsmouth, United States
- DM Clinical Research- CyfairHouston, United States
- SMS Clinical ResearchMesquite, United States
- Dynamed Clinical Research, LP d/b/a DM Clinical ResearchTomball, United States
- J. Lewis Research, Inc. / Foothill Family ClinicSalt Lake City, United States
- J. Lewis Research, Inc. / Foothill Family Clinic SouthSalt Lake City, United States
- Charlottesville Medical ResearchCharlottesville, United States
- Related resource (pmiform.com)