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Bridging study of BARYCELA in healthy Vietnamese children
NCT05664152Phase 3
Key facts
- Status
- Unknown
- Start
- Feb 2023
- Primary completion
- Apr 2023
- Sponsor
- GC Biopharma Corp
- Modality
- Prophylactic Vaccines, DNA Vaccines, Live Biotherapeutic Products
- Conditions
- varicella (VZV)
01
Overview
Phase 3, open-label, single-arm trial of varicella virus vaccine live in varicella (VZV), sponsored by GC Biopharma Corp. Primary endpoints: Solicited local and systemic reactogenicity, Incidence and severity of solicited local and systemic AEs and 3 more. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
MG1111
Participants receive a single dose of BARYCELA inj.
03
Who it enrols
Healthy Vietnamese children aged 12 months to 12 years with no history of varicella infection or vaccination.
04
Endpoints
Primary
Solicited local and systemic reactogenicity
Incidence and severity of solicited local and systemic AEs
Incidence and severity of unsolicited AEs
Incidence of adverse event of special interest
Vital signs
Secondary
Geometric Mean Titer
Geometric Mean Fold Rise
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