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

NCT04384016 | Completed Phase 4

• 1 other identifier: VX.2019.08
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chickenpox; varicella-zoster virus; varicella vaccine

Outcome Measures

Primary Outcomes (4)

• 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 Safety of Skyvaricella Injection

  The incidence and severity of events (local and systemic)

  within 30 minutes after vaccination

• the Safety of Skyvaricella Inj.

  The incidence of expected systemic and local adverse events

  within 7 days after vaccination

• the Safety of Skyvaricella Injection

  The incidence of serious adverse events and Unexpected adverse events

  within 6 weeks after vaccination

Secondary Outcomes (1)

• the Immunogenicity of Skyvaricella Injection

  6 weeks after investigational vaccination

Study Arms (2)

Evaluating the Safety of Skyvaricella Inj.

EXPERIMENTAL

The main target: • Evaluating the safety of Live Attenuated Varicella Vaccine SKYVaricella injection in healthy Vietnamese children from 12 months to 12 years, with a single injection

Biological: Skyvaricella Injection

Evaluating the Immunogenicity of Skyvaricella Inj.

EXPERIMENTAL

Secondary target • Evaluating the immunogenicity of Live Attenuated Varicella Vaccine SKYVaricella injection in a small group of healthy Vietnamese children from 12 months to 12 years, with a single injection.

Biological: Skyvaricella Injection

Interventions

Skyvaricella Injection BIOLOGICAL

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.

Evaluating the Immunogenicity of Skyvaricella Inj.; Evaluating the Safety of Skyvaricella Inj.

Eligibility Criteria

• Age: 12 Months - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children from full 12 months to full 12 years of age, healthy, agreed to participate by parents/guardians and allowed to monitor during the study period.
• The legal parent/guardian signs the study consent form, fully understanding the details of the study. Be fully explained and voluntarily agree to participate in the study and be able to follow the instructions provided by the study.
• The parent / legal guardian agrees in writing and is deemed to be able to cooperate with the study and meet all the requirements described in the protocol during the study.
• If girls are menstruating, a negative pregnancy test should be performed on the day of vaccination and consent to birth control practices within 3 months after vaccination.

You may not qualify if:

• Hypersensitivity reaction to any component of the research vaccine, such as gelatin or neomycin.
• Has been vaccinated against chickenpox before.
• History of chickenpox.
• People who have been exposed to chickenpox at home, day care, school, etc. within 4 weeks before getting the IP vaccine.
• Persons with acute or chronic cardiovascular disorders (CS) of clinical significance (respiratory, endocrine and neurological (including hematological diseases, leukemia), all types of lymphoma and other malignancies affecting the bone marrow or lymphatic system).
• People with a history of hypersensitivity to immunization, or Guillain-Barre syndrome.
• Patients who have used or are expected to use immunosuppressive or immunomodulatory therapies 6 months prior to the study vaccine up to 3 visits (6 + 2 weeks after vaccination) -xin) (e.g. chemotherapy drugs such as Cyclophosphamide, 6-Mercaptopurine, Azathioprine, Methotrexate, Cyclosporine A, Rapamycin and Leflunomide / biological treatments such as tumor necrosis factor \[TNF-α\], antiallergic drugs (antibodies, monoclonal antibodies and antisera / lymphocytes).
• Congenital or acquired immunodeficiency, lowering blood gammaglobulin and blood gammaglobulin disorder.
• Persons with a family history of congenital or hereditary immunodeficiency.
• Persons who live in the same household as a member of a high-risk group for varicella infection (for example, infants aged 0 to 4 weeks, pregnant women without a history of chickenpox vaccination and disease nuclear immunodeficiency factor).
• People currently suffering from tuberculosis.
• Ear canal temperature of 38.0 ° C or higher on the day of the vaccination.
• Those who received or expected to receive salicylate from 14 days before the IP vaccine to the 3rd visit (6 + 2 weeks after the IP vaccine).
• Persons who have received or are expected to receive human immunoglobulins, whole blood or blood-derived products such as packed red blood cells (RBC), intravenous immunoglobulins (IVIG) or globulins immunity to varicella zoster (VZIG) from 5 months prior to the IP vaccine to the 3rd visit (6 + 2 weeks after the IP vaccine).
• Persons who have received or are expected to receive other vaccines 4 weeks prior to the IP vaccine visit 3 (6 + 2 weeks after the IP vaccine).

Sponsors & Collaborators

• Vietnam Military Medical University: lead
• Vabiotech: collaborator

Study Sites (1)

CDC Ha Nam

Phủ Lý, Ha Nam, 18000, Vietnam

Location

MeSH Terms

Conditions

Chickenpox

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Pham N Hung, As. Prof.

  Vietnam Military Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 2, 2020
• First Posted: May 12, 2020
• Study Start: April 17, 2021
• Primary Completion: July 6, 2021
• Study Completion: April 19, 2022
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)