Study of Investigational mRNA Seasonal Flu/COVID-19 Combination Vaccine
This early-stage study is testing a new vaccine called Flu/COVm Vaccine. It's designed to protect against both seasonal flu and COVID-19. Researchers want to see if it's safe and how well your body creates protection (immune response) against these viruses. You could be eligible if you are a healthy adult between 65 and 85 years old. Participants will receive either the Flu/COVm Vaccine at different dose levels, a licensed seasonal influenza vaccine, or a licensed COVID-19 vaccine. The main goal is to track any side effects or health changes, especially in your lab test results, for up to 29 days after getting the vaccine. This helps us understand the vaccine's safety.
- Study design
- This is an interventional study with a planned enrollment of 225 participants. It is an early-stage study, but the specific phase is not mentioned.
- What's involved
- You would receive a single intramuscular injection of one of the study vaccines. Blood samples will be collected at specific times to check your immune response.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your health will be monitored for at least 29 days after receiving the study intervention to check for any changes in lab values.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study on the Safety and Immune Response of Investigational mRNA Seasonal Flu/COVID-19 Combination Vaccine in Adults
At a glance
Conditions
Where it's being run
12 sites across 8 statesWho to contact
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What this trial measures
- Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities Following Administration of the Study InterventionDay 1 to Day 3
The assessed toxicity grades for laboratory value abnormalities will be defined as follows: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, and Grade 4 = Potentially life-threatening.
- Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities following Administration of Study InterventionDay 1 to Day 8
- Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities following Administration of Study InterventionDay 1 to Day 29
- Number of Participants with Solicited Administration Site Adverse Events (AEs)Day 1 to Day 7
The solicited administration site AEs considered are pain, redness, swelling and lymphadenopathy.
- Number of Participants with Solicited Systemic AEsDay 1 to Day 7
The solicited systemic AEs considered are fever, headache, fatigue, myalgia, arthralgia and chills.
- Number of Participants with Unsolicited AEsDay 1 to Day 28
An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
- Number of Participants with Serious Adverse Events (SAEs)Day 1 to Day 181
A SAE is an AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or other situations that are considered serious per medical or scientific judgment.
- Number of Participants with Adverse Events of Special Interest (AESIs)Day 1 to Day 181
The following events are considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, Aminotransferase elevation; myocarditis/pericarditis within 6 weeks after study intervention administration and potential immune-mediated diseases (pIMDs).
- Number of Participants with Medically Attended Adverse Events (MAAEs)Day 1 to Day 181
A MAAE is an AE for which the participant received medical attention including any symptom or illness requiring hospitalization, or an emergency room visit, or visit to/by a healthcare professional.