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Protea trial: OM-85 in moderate-late preterm infants
2024-518498-32-01Phase 3Authorised
- Sponsor
- Franciscus Gasthuis & Vlietland
- Start
- Dec 2024
- Modality
- Whole Cell Cancer Vaccines → Cancer Vaccines → Therapeutic Vaccines → Vaccines & Immunotherapeutics, Split/Subunit Vaccines → Inactivated Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics
- Countries
- 1
01
Overview
Phase 3, randomised, double-blind trial in pulmonary infection, Respiratory viral illness and bacterial airway infections comparing OM-85 (Broncho-Vaxom Kinderen) with Placebo (2 arms). Primary endpoints: Protea-1 and Protea-2. Planned start Dec 2024; status: authorised.
02
Drugs
OM-85
03
Conditions
pulmonary infectionRespiratory viral illnessbacterial airway infections
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