Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Flu Seasonal/SARS-CoV-2 mRNA Dose 1 · 1 trial · 1 indication
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.
The AEs considered are pain, redness, swelling and lymphadenopathy.
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.
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.
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.
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.
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).
| Arm | Type | Description |
|---|---|---|
| mRNA Flu/COVID-19 Dose 1 Group | EXPERIMENTAL | Participants receive one dose of investigational Flu mRNA vaccine composition in combination with a Dose 1 of a COVID-19 component and 1 dose of placebo on Day 1. |
| mRNA Flu/COVID-19 Dose 2 Group | EXPERIMENTAL | Participants receive one dose of a Flu mRNA vaccine composition in combination with a Dose 2 of a COVID-19 component and 1 dose of placebo on Day 1. |
| Flu+COVID-19 Group | ACTIVE_COMPARATOR | Participants receive one dose of a licensed Flu Seasonal vaccine and a licensed mRNA COVID-19 vaccine on Day 1. |
| mRNA Flu Group | ACTIVE_COMPARATOR | Participants receive one dose of an investigational mRNA Flu Seasonal vaccine and 1 dose of placebo on Day 1. |
| mRNA COVID-19 Dose 1 Group | ACTIVE_COMPARATOR | Participants receive one dose of Dose 1 investigational mRNA COVID-19 vaccine and 1 dose of placebo on Day 1. |
| mRNA COVID-19 Dose 2 Group | ACTIVE_COMPARATOR | Participants receive one Dose 2 investigational mRNA COVID-19 vaccine and 1 dose of placebo on Day 1. |
| Name | Type | Description |
|---|---|---|
| Flu Seasonal /SARS-CoV-2 mRNA Dose 1 | COMBINATION_PRODUCT | A Flu mRNA vaccine composition in combination with Dose 1 of a COVID-19 component will be administered. |
| Flu Seasonal /SARS-CoV-2 mRNA Dose 2 | COMBINATION_PRODUCT | A Flu mRNA vaccine composition in combination with Dose 2 of a COVID-19 component will be administered. |
| Flu Seasonal mRNA | COMBINATION_PRODUCT | An investigational mRNA Flu Seasonal vaccine will be administered. |
| SARS-CoV-2 mRNA Dose 1 | COMBINATION_PRODUCT | Dose 1 of an investigational mRNA COVID-19 vaccine will be administered. |
| SARS-CoV-2 mRNA Dose 2 | COMBINATION_PRODUCT | Dose 2 of an investigational mRNA COVID-19 vaccine will be administered. |
| Licensed Flu Seasonal | COMBINATION_PRODUCT | A licensed Flu Seasonal vaccine will be administered. |
| Licensed COVID-19 mRNA | COMBINATION_PRODUCT | A licensed mRNA COVID-19 vaccine will be administered. |
| Placebo | DRUG | A placebo will be administered. |
Inclusion Criteria: * Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits). * Written informed consent obtained from the participant prior to performance of any study-specific p...
Top 9 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | ibuzatrelvir, Nirmatrelvir/ ritonavir, BNT162b2/RIV |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Molnupiravir |
| Invivyd, Inc. | IVVD | 2 | PHASE3 | VYD2311 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Tradipitant |
| Moderna, Inc. | MRNA | 2 | PHASE2 | mRNA-1283, mRNA-1273 |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Traws Pharma, Inc. | TRAW | 1 | PHASE2 | Ratutrelvir |
| GeoVax Labs, Inc. | GOVX | 1 | PHASE2 | GEO-CM04S1 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE2 | Remdesivir |
Flu Seasonal/SARS-CoV-2 mRNA Dose 1 is an investigational RNA therapy developed by GSK plc for COVID-19. It is a combination vaccine candidate designed to address seasonal influenza and SARS-CoV-2 in a single mRNA-based dose, and it has been studied in a Phase 1 clinical trial in adults.
Flu Seasonal/SARS-CoV-2 mRNA Dose 1 is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating this investigational combination vaccine candidate for COVID-19.
Flu Seasonal/SARS-CoV-2 mRNA Dose 1 is in Phase 1 clinical development. It is an investigational vaccine candidate and has not been approved by the FDA. The Phase 1 study evaluating it has been completed.
Flu Seasonal/SARS-CoV-2 mRNA Dose 1 was evaluated in the Phase 1 trial NCT06680375, titled A Study of an Investigational Flu Seasonal/SARS-CoV-2 Combination Vaccine in Adults. The trial enrolled 106 participants in the United States, included healthy volunteers aged 18 years and older, and has been completed.
The Phase 1 trial NCT06680375 for Flu Seasonal/SARS-CoV-2 mRNA Dose 1 was a randomized, double-blind study with an active control. It enrolled 106 participants aged 18 years and older in the United States, including healthy volunteers, and evaluated the investigational combination vaccine in adults.