This study will evaluate the reactogenicity, safety, and immune response of Flu Seasonal/SARS-CoV-2 mRNA (mRNA Flu/COVID-19) combination vaccine. The flu portion will target multiple strains of the flu virus, while the COVID-19 part will focus on the spike protein of the SARS-CoV-2 virus. Both parts of this vaccine have been tested individually before. This will be the first study to test the combined vaccine in humans in healthy adult participants.
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
106
A Flu mRNA vaccine composition in combination with Dose 1 of a COVID-19 component will be administered.
A Flu mRNA vaccine composition in combination with Dose 2 of a COVID-19 component will be administered.
An investigational mRNA Flu Seasonal vaccine will be administered.
GSK Investigational Site
Anniston, Alabama, United States
GSK Investigational Site
Rolling Hills Estates, California, United States
GSK Investigational Site
Hialeah, Florida, United States
GSK Investigational Site
Percentage of participants with increase in grading for at least one laboratory value from administration of study intervention
Food and Drug Administration (FDA) toxicity grading scales for biochemistry hematology parameters are evaluated. Grades are defined as follows: Grade 1 - Mild; Grade 2 - Moderate; Grade 3 - Severe; Grade 4 -Potentially life threatening.
Time frame: From Day 1 to Day 8
Percentage of participants with solicited administration site adverse events (AEs)
The AEs considered are pain, redness, swelling and lymphadenopathy.
Time frame: From Day 1 to Day 7
Percentage of participants with solicited systemic AEs
The AEs considered are fever, headache, fatigue, myalgia, arthralgia and chills. Fever is defined as temperature greater than or equal to (\>=) 38 °C/100.4°F regardless the location of measurement.
Time frame: From Day 1 to Day 7
Percentage 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: From Day 1 to Day 28
Percentage 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: From Day 1 to Day 183 (study end)
Percentage 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.
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Dose 1 of an investigational mRNA COVID-19 vaccine will be administered.
Dose 2 of an investigational mRNA COVID-19 vaccine will be administered.
A licensed Flu Seasonal vaccine will be administered.
A licensed mRNA COVID-19 vaccine will be administered.
A placebo will be administered.
Miami, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Lenexa, Kansas, United States
GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
Omaha, Nebraska, United States
GSK Investigational Site
Rochester, New York, United States
Time frame: From Day 1 to Day 183 (study end)
Percentage 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, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs).
Time frame: From Day 1 to Day 183 (study end)
Geometric mean titer (GMT) ratio of antigen 1 antibody for investigational mRNA Flu/COVID-19 (pooled dose 1 and dose 2) and mRNA flu vaccines
Time frame: At Day 29
GMT ratio of antigen 2 antibody for investigational mRNA Flu/COVID-19 (pooled dose 1 and dose 2) and mRNA flu seasonal vaccines
Time frame: At Day 29
GMT ratio of serum neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s) for investigational mRNA Flu/COVID-19 (pooled dose 1 and dose 2) and mRNA COVID-19 vaccines
Time frame: At Day 29
GMT ratio of antigen 1 antibody for the investigational mRNA Flu/COVID-19 vaccines (dose 1 and 2) and Flu vaccines (pooled group) and licensed Flu vaccine co-administered with a licensed mRNA COVID-19 vaccine
Time frame: At Day 29
GMT ratio of antigen 2 antibody for the investigational mRNA Flu/COVID-19 vaccines (dose 1 and 2) and Flu vaccines (pooled group) and licensed Flu vaccine co-administered with a licensed mRNA COVID-19 vaccine
Time frame: At Day 29
GMT ratio of serum neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s)
GMT ratio of serum neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s) will be evaluated for the investigational mRNA Flu/COVID-19 vaccines and COVID-19 with the same dose (pooled group) and licensed mRNA COVID-19 vaccine co-administered with a licensed Flu Seasonal vaccine.
Time frame: At Day 29
GMTs of antigen 1 antibody for the investigational mRNA Flu/COVID-19 vaccines, mRNA Flu Seasonal vaccine and the licensed Flu Seasonal vaccine co-administered with a licensed mRNA COVID-19 vaccine
Time frame: At Day 92 and Day 183 (Study end)
Geometric mean increase (GMI) in antigen 1 antibody for the investigational mRNA Flu/COVID-19 vaccines, mRNA Flu Seasonal vaccine and the licensed Flu Seasonal vaccine co-administered with a licensed mRNA COVID-19 vaccine
GMI is defined as the geometric mean of the ratios of the post-vaccination titer over the Day 1 titer.
Time frame: From Day 1 to Day 29, from Day 1 to Day 92 and from Day 1 to Day 183 (study end)
Seroconversion rate (SCR) of antigen 1 antibody for the investigational mRNA Flu/COVID-19 vaccines, mRNA Flu Seasonal vaccine and the licensed Flu Seasonal vaccine co-administered with a licensed mRNA COVID-19 vaccine
Time frame: From Day 1 to Day 29, from Day 1 to Day 92 and from Day 1 to Day 183 (study end)
Seroprotection rate (SPR) of antigen 1 antibody for the investigational mRNA Flu/COVID-19 vaccines, mRNA Flu Seasonal vaccine and the licensed Flu Seasonal vaccine co-administered with a licensed mRNA COVID-19 vaccine
Time frame: At Day 1, Day 29, Day 92, and Day 183 (study end)
GMTs of antigen 2 antibody for the investigational mRNA Flu/COVID-19 vaccines, mRNA Flu Seasonal vaccine and the licensed Flu Seasonal vaccine co-administered with a licensed mRNA COVID-19 vaccine
Time frame: At Day 92 and Day 183 (study end)
GMI in antigen 2 antibody for the investigational mRNA Flu/COVID-19 vaccines, mRNA Flu Seasonal vaccine and the licensed Flu Seasonal vaccine co-administered with a licensed mRNA COVID-19 vaccine
GMI is defined as the geometric mean of the ratios of the post-vaccination titer over the Day 1 titer.
Time frame: From Day 1 to Day 29, from Day 1 to Day 92 and from Day 1 to Day 183 (study end)
SCR of antigen 2 antibody in for the investigational mRNA Flu/COVID-19 vaccines, mRNA Flu Seasonal vaccine and the licensed Flu Seasonal vaccine co-administered with a licensed mRNA COVID-19 vaccine
Time frame: From Day 1 to Day 29, from Day 1 to Day 92 and from Day 1 to Day 183 (study end)
GMTs of serum neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s)
GMTs of serum neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s) will be evaluated for the investigational mRNA Flu/COVID-19 vaccines, mRNA COVID-19 vaccine and the licensed mRNA COVID-19 vaccine co-administered with a licensed Flu Seasonal vaccine
Time frame: At Day 92, and Day 183 (study end)
GMI of neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s)
GMI is defined as the geometric mean of the ratios of the post-vaccination titer over the Day 1 titer. GMI of neutralization titers will be evaluated for the investigational mRNA Flu/COVID-19 vaccines, mRNA COVID-19 vaccine and the licensed mRNA COVID-19 vaccine co-administered with a licensed Flu Seasonal vaccine.
Time frame: At Day 29, Day 92, and Day 183 (study end)
Percentage of participants with seroresponse of neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s)
Seroresponse of neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s) will be evaluated for the investigational mRNA Flu/COVID-19 vaccines, mRNA COVID-19 vaccine and the licensed mRNA COVID-19 vaccine co-administered with a licensed Flu Seasonal vaccine.
Time frame: At Day 29, Day 92, and Day 183 (study end)