WHO ICTRP trial
EUCTR2017-004971-30-BE · FluGen, Inc
EUCTR2017-004971-30-BE · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2017-004971-30-BE |
|---|---|
| Scientific title | A Phase 2a Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Immunogenicity, and Efficacy of Bris10 M2SR (H3N2 A/Brisbane/10/2007) Vaccine Administered as a Single Intranasal Dose (Versus Placebo) in Healthy Adult Volunteers who are Subsequently Challenged with a Live… |
| Primary sponsor | FluGen, Inc |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | Belgium |
| Conditions | Prophylactic H3N2(A/Brisbane/10/2007) monovalent influenza vaccine, Bris10 M2SR, for protection against influenza disease caused by seasonal influenza A viruses. MedDRA version: 20.0 Level: HLT Classification code 10022005 Term: Influenza… |
| Interventions | Product Name: Bris10 M2SR Vaccine Pharmaceutical Form: Nasal spray, solution INN or Proposed INN: na CAS Number: na Current Sponsor code: Bris10 M2SR Vaccine Pharmaceutical form of the placebo: Solution for injection Route of administration… |
| Registration date | Feb 28, 2018 |
| Target size | 120 |
| Secondary IDs | FLUGEN-H3N2-V002 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: