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UnknownNCT05664152

An Open-label, Bridging Study of BARYCELA Inj. in Healthy Vietnamese Children Aged Between 12 Months to 12 Years

An Open-label, Bridging Study to Assess the Safety and Immunogenicity of BARYCELA Inj. (Live Attenuated Varicella Vaccine for Injection) in Healthy Vietnamese Children Aged Between 12 Months to 12 Years

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
250 (estimated)
Sponsor
GC Biopharma Corp · Industry
Sex
All
Age
12 Months – 12 Years
Healthy volunteers
Accepted

Summary

The goal of this bridging study is to assess the safety and immunogenicity of BARYCELA inj. in healthy Vietnamese children aged between 12 months to 12 years. The main questions it aims to answer are: * Safety of BARYCELA inj. (Live attenuated varicella vaccine for injection) * Immunogenicity of BARYCELA inj. (Live attenuated varicella vaccine for injection) Participants will be administered subcutaneously with a single dose(0.5 mL dose) of the BARYCELA inj.(MG1111) on the upper arm (brachia lateral).

Conditions

Interventions

TypeNameDescription
BIOLOGICALMG1111BARYCELA inj.

Timeline

Start date
2023-02-01
Primary completion
2023-04-01
Completion
2023-06-01
First posted
2022-12-23
Last updated
2022-12-23

Source: ClinicalTrials.gov record NCT05664152. Inclusion in this directory is not an endorsement.

An Open-label, Bridging Study of BARYCELA Inj. in Healthy Vietnamese Children Aged Between 12 Months to 12 Years (NCT05664152) · Clinical Trials Directory