Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
mRNA-1325 · 1 trial · 1 indication
Solicited adverse reactions (ARs) (local and systemic) were collected in the electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema, and injection site induration/swelling. Systemic ARs included: body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, chills, and rash. Data for this outcome measure is reported up to 7 days after the first study vaccination only. A summary of all serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section.
Solicited adverse reactions (ARs) (local and systemic) were collected in the electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema, and injection site induration/swelling. Systemic ARs included: body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, chills, and rash. Data for this outcome measure is reported up to 7 days after the second study vaccination only. A summary of all serious AEs (SAEs) and all nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section.
An unsolicited AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The treatment-emergent AEs are defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure. A summary of all 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 MAAE is an AE that leads to an unscheduled visit to an healthcare practitioner. A summary of all SAEs and all nonserious AEs ("Other"), 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, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions was a congenital anomaly/birth defect, or was an important medical event. AESIs included potentially immune-mediated medical conditions (autoimmune or autoinflammatory diseases) that may have the theoretical potential for association with novel vaccines. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
| Arm | Type | Description |
|---|---|---|
| mRNA-1325 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | 0.9% sodium chloride |
| Name | Type | Description |
|---|---|---|
| mRNA-1325 | BIOLOGICAL | Escalating dose levels |
| Placebo | OTHER | - |
Inclusion * 18 to 49 years of age * Body mass index between 18 and 35 kg/m2 * In good health as determined by medical history * Female subjects must be non pregnant and non lactating and meet one of the following criteria: a) post menopausal b) surgically sterile * Women of childbearing potential m...
mRNA-1325 is an investigational vaccine being developed for the prevention of Zika virus infection. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The vaccine is designed to elicit an immune response against the Zika virus, though its efficacy has not yet been established.
mRNA-1325 is being developed by Moderna, Inc., a biotechnology company traded on the NASDAQ under the ticker symbol MRNA. The company is conducting clinical trials to evaluate the safety, tolerability, and immunogenicity of this investigational Zika virus vaccine.
mRNA-1325 is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by the FDA or any other regulatory agency. The Phase 1 trial has been completed, and the vaccine remains under clinical investigation for the prevention of Zika virus infection.
mRNA-1325 has been evaluated in one completed Phase 1 clinical trial, identified as NCT03014089. This study, titled "Safety, Tolerability, and Immunogenicity of mRNA-1325 in Healthy Adult Subjects," enrolled 90 healthy adult participants in the United States. The trial was randomized, double-blind, and placebo-controlled.
No, mRNA-1325 is not a monoclonal antibody. Although it is categorized under the modality of monoclonal antibody in some databases, mRNA-1325 is actually an mRNA-based vaccine designed to prevent Zika virus infection. It works by instructing cells to produce a viral protein to trigger an immune response, rather than acting as a pre-made antibody.