Clinical Trials Logo
  1. Home
  2. Chickenpox
  3. NCT04384016

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

Chickenpox Clinical Trial

Official title:
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

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

Clinical Trial Details
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
View Details
See also
  Status Clinical Trial Phase
Completed NCT01887496 - Varicella-related Hospitalizations in Turkey N/A
Completed NCT02570126 - A Safety and Immune Study of 2 Types of GlaxoSmithKline's Varicella Vaccines Given as a 2-doses Course to Healthy Children 12-23 Months of Age. Phase 3
Completed NCT00326183 - Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED) Phase 4
Completed NCT02452229 - Review of Human Herpes Viruses in Burns N/A
Completed NCT01817270 - Immunogenicity and Safety Study of 2 Doses of Live Attenuated Varicella Vaccine Phase 4
Completed NCT01815073 - Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Live Attenuated JE Vaccine Phase 4
Active, not recruiting NCT01982409 - Immune Persistence After Inoculated With One-dose Freeze-Dried Live Attenuated Varicella Vaccine in Children Vaccine in Children Phase 4
Completed NCT00921999 - Immune Response to Varicella-Zoster Vaccination and Infection N/A
Completed NCT00098046 - Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection Phase 3
Completed NCT05732337 - Open Clinical Investigation to Evaluate the Effectiveness and Safety of a Topical Medical Device. N/A
Completed NCT01684072 - Safety and Immunogenicity Study of Live Attenuated Vaccine Against Varicella Without Gelatin Phase 4
Completed NCT00156559 - MMR and Varicella Vaccine in Premature Infants Phase 4
Active, not recruiting NCT05084508 - A Study on the Immune Response and Safety of Various Potencies of an Investigational Chickenpox Vaccine Compared With a Marketed Chickenpox Vaccine, Given to Healthy Children 12 to 15 Months of Age Phase 2
Withdrawn NCT00001054 - The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children Phase 1
Completed NCT00002358 - A Study of BV-araU in the Treatment of Varicella-Zoster Viral Disease (VZV) in HIV-Infected Children Who Have Not Had Success With or Who Cannot Take Other Treatments for VZV Phase 3
Completed NCT00002315 - A Comparison of 882C87 Versus Acyclovir in the Treatment of Herpes Zoster in Patients With Weakened Immune Systems Phase 3
Completed NCT00001125 - Use of a Varicella-Zoster Virus (VZV) Vaccine to Prevent Shingles in HIV-Infected Children Who Have Already Had Chickenpox Phase 1
Completed NCT00000953 - Comparison of Brovavir Versus Acyclovir in the Treatment of Herpes in HIV-Infected Patients Phase 2