Phase I, First-In Human Study to Evaluate Safety and Tolerability of EuRSV in Healthy Adults Aged Between 19 Years and 80 Years
NCT06216093 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2025-06-15
Summary
Phase 1 clinical trial to evaluate the safety of RSV-1 and RSV-2 vaccines in healthy adults aged 19 to 80 years who have voluntarily given written consent to participate in this study.
Conditions
- Respiratory Syncytial Virus Infections
- Respiratory Syncytial Virus (RSV)
Interventions
- BIOLOGICAL
-
EuRSV
Healthy adults received 0.5mL single intramuscular dose on Day 0 and Day 28.
- OTHER
-
Placebo Comparator
Healthy adults received 0.5mL single intramuscular dose on Day 0 and Day 28.
Sponsors & Collaborators
-
EuBiologics Co.,Ltd
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-05-08
- Primary Completion
- 2025-07-31
- Completion
- 2025-09-30
Countries
- South Korea
Study Locations
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