NCT04384016 is a Phase 4 clinical trial of Skyvaricella Injection in Chickenpox, sponsored by Vietnam Military Medical University.

Who is sponsoring NCT04384016?

NCT04384016 is sponsored by Vietnam Military Medical University.

What drugs are being tested in NCT04384016?

Interventions in NCT04384016: Skyvaricella Injection.

What condition does NCT04384016 study?

NCT04384016 studies Chickenpox.

Is NCT04384016 still recruiting?

NCT04384016 is currently completed. Last updated 6 July 2023.

Last reviewed 2023-07-06 · How we verify

NCT04384016

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 4 Last updated 6 July 2023

What this trial tests

Phase 4 trial testing Skyvaricella Injection in Chickenpox in 201 participants. Completed in 19 April 2022.

Timeline

17 April 2021

Primary endpoint
6 July 2021

19 April 2022

Quick facts

Lead sponsor	Vietnam Military Medical University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	prevention
Enrollment	201
Start date	17 April 2021
Primary completion	6 July 2021
Estimated completion	19 April 2022
Sites	1 location across Vietnam

Drugs / interventions tested

Skyvaricella Injection

Conditions studied

Chickenpox — all drugs for Chickenpox →

Sponsor

Vietnam Military Medical University

Who can join

Adults 12 Months to 12, any sex, with Chickenpox. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Safety and Immunogenicity of the Live Attenuated Varicella Vaccine in Vietnamese Children Aged 12 Months to 12 Years: An Open-Label, Single-Arm Bridging Study.
Hung PV, Giang LTH, Toi PL, Thuc VTM, et al · · 2024 · PMID 38932134 · DOI 10.3390/v16060841

Verify or expand the search:

Other recruiting trials for Chickenpox

Currently open trials in the same condition.

NCT06806137 — A Study on the Immune Response and Safety of the Second Dose of an Investigational Chickenpox Vaccine When Given to Heal · Phase 3 · recruiting
NCT06855160 — A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine and a Marketed Measles, Mumps and Rub · Phase 3 · recruiting
NCT06740630 — A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to · Phase 3 · recruiting
NCT06693895 — A Study on the Safety of an Investigational Chickenpox Vaccine, When Given to Healthy Children, 12 to 15 Months of Age · Phase 3 · recruiting

Other Vietnam Military Medical University trials

Trials by the same sponsor.

NCT06733168 — The Impact of PEEP-guided Electrical Impedance Tomography on Oxygenation and Pulmonary Mechanics in Moderate-to-severe A · NA · recruiting
NCT04695717 — This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Un · Phase 3 · completed
NCT05937113 — Safety and Immunogenicity of the Inactivated Rabies Vaccine RABIVAX-S Administered Intramuscularly and Intradermally · Phase 4 · completed
NCT04546932 — Lung-protective Mechanical Ventilation for Abdominal Laparoscopic Surgeries · NA · completed
NCT06042816 — Analgesic Efficacy of Free-opioid Anesthesia for Colorectal Surgery · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04384016 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vietnam Military Medical University
Last refreshed: 6 July 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04384016.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing