This early-stage study will look at a new mRNA vaccine that combines defenses against both seasonal flu and COVID-19 in terms of its safety and how it builds protection. Healthy adults aged 65 to 85 will receive different doses of this new vaccine, a standard flu vaccine, or COVID-19 vaccine. The study will assess any side effects or health issues, and additional blood samples will be collected at specific times to evaluate how well participants bodies build protection against the flu and COVID-19.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
225
Flu/COVm Vaccine with multiple dose levels (Dose Level 1, Dose Level 2, and Dose Level 3), will be administered via single intramuscular injection.
License Seasonal Influenza Vaccine will be administered as a single intramuscular dose.
Licensed COVID-19 Vaccine will be administered as a single intramuscular dose.
GSK Investigational Site
Anniston, Alabama, United States
RECRUITINGGSK Investigational Site
Little Rock, Arkansas, United States
RECRUITINGGSK Investigational Site
Fair Oaks, California, United States
RECRUITINGGSK Investigational Site
San Diego, California, United States
RECRUITINGGSK Investigational Site
Miami, Florida, United States
RECRUITINGGSK Investigational Site
Miami Lakes, Florida, United States
RECRUITINGGSK Investigational Site
West Palm Beach, Florida, United States
RECRUITINGGSK Investigational Site
Stockbridge, Georgia, United States
RECRUITINGGSK Investigational Site
Austin, Texas, United States
RECRUITINGGSK Investigational Site
Charlottesville, Virginia, United States
RECRUITING...and 2 more locations
Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities Following Administration of the Study Intervention
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.
Time frame: Day 1 to Day 3
Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities following Administration of Study Intervention
Time frame: Day 1 to Day 8
Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities following Administration of Study Intervention
Time frame: Day 1 to Day 29
Number of Participants with Solicited Administration Site Adverse Events (AEs)
The solicited administration site AEs considered are pain, redness, swelling and lymphadenopathy.
Time frame: Day 1 to Day 7
Number of Participants with Solicited Systemic AEs
The solicited systemic AEs considered are fever, headache, fatigue, myalgia, arthralgia and chills.
Time frame: Day 1 to Day 7
Number of Participants with Unsolicited AEs
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.
Time frame: Day 1 to Day 28
Number of Participants with Serious Adverse Events (SAEs)
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.
Time frame: Day 1 to Day 181
Number of Participants with Adverse Events of Special Interest (AESIs)
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).
Time frame: Day 1 to Day 181
Number of Participants with Medically Attended Adverse Events (MAAEs)
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.
Time frame: Day 1 to Day 181
Geometric Mean Titer (GMT) Of Antigen 1 Titer
Time frame: At Day 29
Percentage of Participants with Antigen 1 Seroconversion Rate (SCR)
Time frame: Day 1 to Day 29
Percentage of Participants with Antigen 1 Seroprotection Rate (SPR)
Time frame: At Day 1 and Day 29
Geometric Mean Increase (GMI) of Antigen 1 Titer
Time frame: Day 1 to Day 29
GMT Of Antigen 2 Titer
Time frame: At Day 29
Percentage of Participants with Antigen 2 SCR
Time frame: Day 1 to Day 29
GMI of Antigen 2 Titer
Time frame: Day 1 to Day 29
GMT ratio of serum neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s)
Time frame: At Day 29
Percentage of participants with seroresponse of neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s)
Time frame: Day 1 to Day 29
GMI of neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s)
Time frame: Day 1 to Day 29
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