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

NCT04384016 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2023-07-06

No results posted yet for this study

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.

Conditions

  • Chickenpox

Interventions

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.

Sponsors & Collaborators

  • Vabiotech

    collaborator INDUSTRY

  • Vietnam Military Medical University

    lead OTHER

Principal Investigators

  • Pham N Hung, As. Prof. · Vietnam Military Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
12 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-17
Primary Completion
2021-07-06
Completion
2022-04-19

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04384016 on ClinicalTrials.gov