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 developed to prevent Zika virus infection. It was studied in healthy adult volunteers aged 18 years and older in the United States. The vaccine candidate is designed for the infectious disease therapeutic area and has been evaluated in a single completed Phase 1 clinical trial.
mRNA-1325 is being developed by Moderna, Inc., which trades on the Nasdaq under the ticker symbol MRNA. The company sponsored the Phase 1 study of the vaccine candidate in healthy adult subjects. Moderna is the sole developer named for this Zika virus vaccine program.
mRNA-1325 is in Phase 1 development. Its only clinical trial, NCT03014089, has been completed. The study was a randomized, double-blind, placebo-controlled Phase 1 trial evaluating safety, tolerability, and immunogenicity in 90 healthy adult subjects. No active trials of mRNA-1325 are currently listed.
mRNA-1325 has been studied in one clinical trial, NCT03014089, titled Safety, Tolerability, and Immunogenicity of mRNA-1325 in Healthy Adult Subjects. The Phase 1 trial enrolled 90 healthy adult volunteers in the United States, was randomized, double-blind, and placebo-controlled, and is now completed.
No. mRNA-1325 is an investigational vaccine candidate and is not approved. It remains in clinical development, with only a completed Phase 1 trial (NCT03014089) evaluating its safety, tolerability, and immunogenicity in 90 healthy adult subjects. Further clinical testing would be required before any regulatory approval could be considered.