NCT04384016

Safety and Immunogenicity of Skyvaricella Injection in Healthy Volunteer Vietnamese Children From 12 Months to 12 Years Old

A Cross-over, Open-label, Single-group Study to Evaluate the Safety and Immunogenicity of Live Attenuated Varicella Vaccine Skyvaricella Injection (Inj.) Developed by SK Bioscience (Company Limited) Co., Ltd of South Korea in Healthy Volunteer Vietnamese Children From 12 Months to 12 Years Old

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Vietnam Military Medical University · Academic / Other
• Sex: All
• Age: 12 Months – 12 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Chickenpox

Interventions

Type	Name	Description
BIOLOGICAL	Skyvaricella Injection	The main target is evaluating the safety of SKYVaricella injection in healthy Vietnamese children from 12 months to 12 years, with a single injection. The secondary target is to Assess the immunogenicity of SKYVaricella inj. in a small group of healthy Vietnamese children from 12 months to 12 years, with a single injection.

Timeline

• Start date: 2021-04-17
• Primary completion: 2021-07-06
• Completion: 2022-04-19
• First posted: 2020-05-12
• Last updated: 2023-07-06

Locations

1 site across 1 country: Vietnam