Approval Probability
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INO-3401+ EP · 1 trial · 1 indication
Frequency and severity of local and systemic reactogenicity, signs and symptoms, adverse events and serious adverse events.
| Arm | Type | Description |
|---|---|---|
| All subjects | EXPERIMENTAL | All subjects will receive 0.9mg/mL of study vaccine (INO-3401 DNA plasmid vaccine) at Day o and Month 3. |
| Name | Type | Description |
|---|---|---|
| INO-3401 + EP | BIOLOGICAL | All subjects will receive 0.9mg/mL of study vaccine (INO-3401 DNA plasmid vaccine)at Day 0 and Month 3. |
Inclusion Criteria: * Written informed consent in accordance with institutional guidelines. If required by local law, candidates must also authorize the release and use of protected health information (PHI); * Enrollment in and received at least one vaccination in study FLU-001; * Adults of either ...
INO-3401+ EP is an investigational product studied in healthy volunteers. It was evaluated in a Phase 1 clinical trial as a follow-on H5 influenza vaccine for subjects who previously participated in study FLU-001. The trial enrolled 22 participants in the United States.
INO-3401+ EP is developed by Inovio Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol INO. The company conducted a Phase 1 clinical trial of this product in healthy volunteers in the United States.
INO-3401+ EP is in Phase 1 clinical development. It is an investigational product and has not been approved by regulatory authorities. The Phase 1 trial, NCT01403155, has been completed, and the product remains in early-stage clinical investigation.
INO-3401+ EP was studied in one completed Phase 1 clinical trial, NCT01403155, titled 'A Follow-On Study With an H5 Influenza Vaccine for Subjects Who Participated in Study FLU-001.' The trial enrolled 22 healthy volunteers in the United States and was not randomized or double-blinded.
INO-3401+ EP is classified as a monoclonal antibody modality. It was evaluated as an H5 influenza vaccine in a Phase 1 follow-on study for healthy subjects who had previously participated in study FLU-001. The trial enrolled 22 participants in the United States.