Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
mRNA-1073 · 1 trial · 2 indications
Solicited ARs (local and systemic) were collected in the electronic diary (eDiary). Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. Note, that not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of all serious AEs (SAEs) and all nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A treatment-emergent AE (TEAE) was defined as any event not present before exposure to vaccine or any event already present that worsens in intensity or frequency after exposure. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsens from baseline and is considered clinically significant in the medical and scientific judgment of the Investigator. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study, regardless of causality, is located in the Reported "Adverse Events" section.
An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner. This would include visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or COVID-19 and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
| Arm | Type | Description |
|---|---|---|
| mRNA-1273 Plus Placebo | EXPERIMENTAL | Participants will receive 2 intramuscular (IM) injections, one in each arm, of mRNA-1273 plus placebo at the specified dose level on Day 1. |
| mRNA-1010 Plus Placebo | EXPERIMENTAL | Participants will receive 2 IM injections, one in each arm, of mRNA-1010 plus placebo at the specified dose level on Day 1. |
| mRNA-1010 Plus mRNA-1273 | EXPERIMENTAL | Participants will receive 2 IM injections, one in each arm, of mRNA-1010 plus mRNA-1273 at the specified dose level on Day 1. |
| Dose A: mRNA-1073 Plus Placebo | EXPERIMENTAL | Participants will receive 2 IM injections, one in each arm, of mRNA-1073 plus placebo at the specified dose level on Day 1. |
| Dose B: mRNA-1073 Plus Placebo | EXPERIMENTAL | Participants will receive 2 IM injections, one in each arm, of mRNA-1073 plus placebo at the specified dose level on Day 1. |
| Dose C: mRNA-1073 Plus Placebo | EXPERIMENTAL | Participants will receive 2 IM injections, one in each arm, of mRNA-1073 plus placebo at the specified dose level on Day 1. |
| Name | Type | Description |
|---|---|---|
| mRNA-1073 | BIOLOGICAL | Sterile liquid for injection |
| mRNA-1010 | BIOLOGICAL | Sterile liquid for injection |
| mRNA-1273 | BIOLOGICAL | Sterile liquid for injection |
| Placebo | BIOLOGICAL | 0.9% sodium chloride (normal saline) injection |
Inclusion Criteria: * Body mass index (BMI) of 18 kilograms per meter squared (kg/m\^2) to 35 kg/m\^2 (inclusive) at the Screening Visit. * Participants must have been fully vaccinated for COVID-19 primary series according to the locally authorized or approved regimen, and their last COVID-19 vacci...
mRNA-1073 is an investigational combination vaccine developed by Moderna, Inc. that targets both SARS-CoV-2 and influenza. It is designed to protect against COVID-19 and seasonal flu in a single vaccine. It is in Phase 1 clinical development and is not approved for use.
mRNA-1073 targets the COVID-19 spike protein and influenza HA glycoproteins. By encoding both antigens, the vaccine aims to generate immune responses against SARS-CoV-2 and influenza viruses simultaneously. Both targets are proteins, and the vaccine uses mRNA technology to instruct cells to produce these antigens.
mRNA-1073 is developed by Moderna, Inc., which trades on the Nasdaq under the ticker MRNA. Moderna is the sponsor of the clinical program evaluating this combination vaccine candidate.
mRNA-1073 is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by the FDA. The Phase 1 trial has been completed, and no active trials are currently listed for this candidate.
mRNA-1073 has been studied in one Phase 1 trial, NCT05375838, titled A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1073 (COVID-19/Influenza) Vaccine in Adults 18 to 75 Years Old. The trial enrolled 550 participants in the United States and has been completed.
mRNA-1073 is being developed for protection against SARS-CoV-2 and influenza. It is a combination vaccine candidate intended to prevent COVID-19 and seasonal flu. The Phase 1 trial evaluated its safety, reactogenicity, and immunogenicity in adults aged 18 to 75 years.