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...
Flu Seasonal/SARS-CoV-2 mRNA Dose 1 is an investigational RNA therapy being developed for COVID-19. It is designed as a combination vaccine targeting seasonal flu and SARS-CoV-2, the virus that causes COVID-19. The drug is currently in Phase 1 clinical development.
Flu Seasonal/SARS-CoV-2 mRNA Dose 1 is being developed by GSK plc, a biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and immunogenicity of this investigational combination vaccine.
Flu Seasonal/SARS-CoV-2 mRNA Dose 1 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The Phase 1 trial has been completed.
Flu Seasonal/SARS-CoV-2 mRNA Dose 1 was studied in a Phase 1 clinical trial with the identifier 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 and has been completed.
Flu Seasonal/SARS-CoV-2 mRNA Dose 1 is an investigational combination vaccine designed to target both seasonal flu and SARS-CoV-2. It is not the same as a standalone flu vaccine, as it also aims to provide protection against COVID-19. The drug is currently in Phase 1 development.