drugset / Trial / NCT03450915
A Pivotal Trial to Assess the Safety and Clinical Efficacy of the M-001 as a Standalone Universal Flu Vaccine
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The pivotal Phase 3 trial plans to enroll a total of approximately 12,460 participants aged 50+ over two years. Participants will be immunized twice with the M-001 universal influenza vaccine candidate or placebo and then followed for up to 2 seasons. The trial will evaluate the number of influenza cases in each group and the severity of illness during the follow up period.
Timeline
- Start
- 2018-08-01
- Primary completion
- 2020-07-02
- Completion
- 2020-10-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Multimeric-001 | Vaccine | 1 mg | Intramuscular |