Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
mRNA-04 vaccine 100μg · 1 trial · 1 indication
The solicited administration site events are pain, redness, swelling and lymphadenopathy (axillary swelling/ tenderness on the same side of the body as the site of injection). Any = occurrence of the event regardless of intensity grade.
The solicited systemic events are fever, headache, myalgia (muscle pain), arthralgia (joint pain), fatigue (tiredness), chills, abdominal pain, vomiting and diarrhea. Fever is defined as body temperature ≥38ºC; preferred location for measuring the temperature is oral. Any = occurrence of the event regardless of intensity grade.
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs. Any = occurrence of the event regardless of intensity grade.
The hematological and biochemical parameters included alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), total bilirubin, creatinine, direct bilirubin, basophils, eosinophils increase, erytrocytes, hemoglobin decrease, lymphocytes decrease, mean corpuscular hemoglobin, mean corpuscular volume, monocytes, neutrophils decrease, platelets decrease, white blood cells (WBC) increase. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
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. Any = occurrence of the event regardless of intensity grade.
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcome or any other situation as determined by the investigator. Any = occurrence of the event regardless of intensity grade.
AESIs include potential immune-mediated diseases (pIMDs) which are autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology, myocarditis, and pericarditis, virologically confirmed COVID-19 cases, anaphylaxis, or severe hypersensitivity within 24 hours after study investigational product administration. Any = occurrence of the event regardless of intensity grade.
| Arm | Type | Description |
|---|---|---|
| Part A, Group 1: mRNA CR-04 10 µg | EXPERIMENTAL | Participants received mRNA 10 micrograms (µg) administered on Day 1. |
| Part A, Group 1: Placebo | PLACEBO_COMPARATOR | Participants received placebo dose administered on Day 1. |
| Part A, Group 2: mRNA CR-04 30 µg | EXPERIMENTAL | Participants received placebo dose administered on Day 1. |
| Part A, Group 2: Placebo | PLACEBO_COMPARATOR | Participants received placebo dose administered on Day 1. |
| Part A, Group 3: mRNA CR-04 100 µg | EXPERIMENTAL | Participants received mRNA 100 µg administered on Day 1 |
| Part A, Group 3: Placebo | PLACEBO_COMPARATOR | Participants received placebo dose administered on Day 1. |
| Part B: mRNA CR-04 3 µg | EXPERIMENTAL | Participants received mRNA 3 µg administered on Day 1. |
| Part B: mRNA CR-04 10 µg | EXPERIMENTAL | Participants received mRNA 10 µg administered on Day 1. |
| Part B: Placebo | PLACEBO_COMPARATOR | Participants received placebo dose administered on Day 1. |
| Name | Type | Description |
|---|---|---|
| mRNA-CR-04 vaccine 10μg | BIOLOGICAL | mRNA CR-04 vaccine, 10 µg, is administered intramuscularly into the deltoid muscle of the non-dominant arm on day 1. |
| mRNA-CR-04 vaccine 30μg | BIOLOGICAL | mRNA CR-04 vaccine, 30 µg, is administered intramuscularly into the deltoid muscle of the non-dominant arm on day 1. |
| mRNA-CR-04 vaccine 100μg | BIOLOGICAL | mRNA CR-04 vaccine, 100 µg, is administered intramuscularly into the deltoid muscle of the non-dominant arm on day 1. |
| Placebo | DRUG | Placebo is administered intramuscularly into the deltoid muscle of the non-dominant arm on day 1. |
| mRNA-CR-04 vaccine 3μg | BIOLOGICAL | mRNA CR-04 vaccine, 3 µg, is administered intramuscularly into the deltoid muscle of the non-dominant arm on day 1. |
Inclusion Criteria: 1. Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure. 2. Participants, who in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary and stu...
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| 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 |
mRNA-04 vaccine 100μg is an investigational mRNA vaccine developed by GSK plc for prevention of COVID-19. It is a 100 microgram dose formulation studied in healthy adults. The vaccine is in Phase 1 clinical development and has been evaluated in a completed safety and immune response trial.
mRNA-04 vaccine 100μg is being developed for the prevention of COVID-19, the disease caused by the SARS-CoV-2 coronavirus. It is intended for use in healthy adults aged 18 years and older. The vaccine remains investigational and has not been approved for any indication.
mRNA-04 vaccine 100μg is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating this mRNA-based COVID-19 vaccine candidate.
mRNA-04 vaccine 100μg is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by the FDA or any regulatory authority. The Phase 1 trial has been completed.
mRNA-04 vaccine 100μg has been studied in one Phase 1 clinical trial, NCT05972993, titled A Safety and Immune Response Study to Evaluate Varying Doses of an mRNA Vaccine Against Coronavirus Disease 2019 (COVID-19) in Healthy Adults. The trial enrolled 114 participants in the United States and is completed.