Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
mRNA-04 vaccine 10μg · 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...
mRNA-04 vaccine 10μg is an investigational vaccine being developed for the prevention of COVID-19. It is currently in Phase 1 clinical development and is intended for use in healthy adults. The vaccine is designed to elicit an immune response against the coronavirus that causes COVID-19.
mRNA-04 vaccine 10μg is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and immune response of this vaccine candidate.
mRNA-04 vaccine 10μg is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. A Phase 1 trial has been completed to evaluate its safety and immunogenicity in healthy adults.
mRNA-04 vaccine 10μg has been studied in one clinical trial, identified as NCT05972993. This was a Phase 1, randomized, double-blind, placebo-controlled study that evaluated varying doses of the vaccine against COVID-19 in healthy adults in the United States. The trial has been completed.
mRNA-04 vaccine 10μg is a distinct investigational vaccine candidate developed by GSK. It is not known to be the same as any other approved or investigational COVID-19 vaccine. Its specific formulation and dosing are unique to this clinical development program.