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Clinical Trial Summary

This is a cross-over, open-label, single-group study. The study subjects were children 12 months to 12 years of age who will be vaccinated with a single dose. The duration of follow-up for safety evaluation and immunogenicity (on a small group) is 6 weeks (+ 2 weeks). The main target: • Evaluating the safety of live attenuated Varicella vaccine [Oka / SK], lyophilized powder and solvent for subcutaneous injection (SKYVaricella inj.) in healthy Vietnamese children from 12 months to 12 years, with a single injection. Secondary target: • Assess the immunogenicity of live attenuated Varicella vaccine [Oka / SK], lyophilized powder and solvent for subcutaneous injection (SKYVaricella inj.) in a small group of healthy Vietnamese children from 12 months to 12 years, with a single injection.


Clinical Trial Description

The Safety of Skyvaricella Injection: - The incidence of a chickenpox-like local rash (injection site) or chickenpox-like rash (disseminated) between 1 and 6 weeks after vaccination - The incidence and severity of events (local and systemic) within 30 minutes after vaccination - The incidence of expected systemic and local adverse events within 7 days after vaccination - The incidence of serious adverse events and Unexpected adverse events within 6 weeks after vaccination The Immunogenicity of Skyvaricella Injection: seroconversion rate by Fluorescent antibody to membrane antigens (FAMA) test 6 weeks after investigational vaccination ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04384016
Study type Interventional
Source Vietnam Military Medical University
Contact
Status Completed
Phase Phase 4
Start date April 17, 2021
Completion date April 19, 2022

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