Safety and Immunogenicity of Skyvaricella Injection in Healthy Volunteer Vietnamese Children From 12 Months to 12 Years Old
Primary Purpose
Chickenpox
Status
Completed
Phase
Phase 4
Locations
Vietnam
Study Type
Interventional
Intervention
Skyvaricella Injection
Sponsored by
About this trial
This is an interventional prevention trial for Chickenpox focused on measuring Chickenpox; varicella-zoster virus; varicella vaccine
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- Those who received or expected to receive steroids from 3 months prior to the IP vaccine to the 3rd visit (6 + 2 weeks after the IP vaccine) (However, in the case of steroid use Low doses [eg <2 mg Prednison / kg / day up to a maximum of 20 mg / day for <2 weeks], the patient can participate in the study if use can be suspended until 3rd Visit after getting the IP vaccine).
- Persons who received or expected to receive antiretroviral drugs from 1 month prior to the IP vaccine to 3rd visits (6 weeks after vaccination + 2 weeks) during the clinical study period ( However, in the case of topical antiviral drugs, patients can participate in the study).
- People who received or expected to receive other IPs in another clinical study from 1 month before the IP vaccine to the 3rd visit (6 + 2 weeks after the IP vaccine).
- Others are considered ineligible to participate in research according to the researcher's judgment.
Sites / Locations
- CDC Ha Nam
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Evaluating the Safety of Skyvaricella Inj.
Evaluating the Immunogenicity of Skyvaricella Inj.
Arm Description
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
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.
Outcomes
Primary Outcome Measures
the Safety of Skyvaricella Injection
The incidence of a chickenpox-like local rash (injection site) or chickenpox-like rash (disseminated).
the Safety of Skyvaricella Injection
The incidence and severity of events (local and systemic)
the Safety of Skyvaricella Inj.
The incidence of expected systemic and local adverse events
the Safety of Skyvaricella Injection
The incidence of serious adverse events and Unexpected adverse events
Secondary Outcome Measures
the Immunogenicity of Skyvaricella Injection
seroconversion rate by Fluorescent antibody to membrane antigens (FAMA) test
Full Information
NCT ID
NCT04384016
First Posted
May 2, 2020
Last Updated
July 2, 2023
Sponsor
Vietnam Military Medical University
Collaborators
Vabiotech
1. Study Identification
Unique Protocol Identification Number
NCT04384016
Brief Title
Safety and Immunogenicity of Skyvaricella Injection in Healthy Volunteer Vietnamese Children From 12 Months to 12 Years Old
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 17, 2021 (Actual)
Primary Completion Date
July 6, 2021 (Actual)
Study Completion Date
April 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vietnam Military Medical University
Collaborators
Vabiotech
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chickenpox
Keywords
Chickenpox; varicella-zoster virus; varicella vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
201 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Evaluating the Safety of Skyvaricella Inj.
Arm Type
Experimental
Arm Description
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
Arm Title
Evaluating the Immunogenicity of Skyvaricella Inj.
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Skyvaricella Injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
the Safety of Skyvaricella Injection
Description
The incidence of a chickenpox-like local rash (injection site) or chickenpox-like rash (disseminated).
Time Frame
between 1 and 6 weeks after vaccination
Title
the Safety of Skyvaricella Injection
Description
The incidence and severity of events (local and systemic)
Time Frame
within 30 minutes after vaccination
Title
the Safety of Skyvaricella Inj.
Description
The incidence of expected systemic and local adverse events
Time Frame
within 7 days after vaccination
Title
the Safety of Skyvaricella Injection
Description
The incidence of serious adverse events and Unexpected adverse events
Time Frame
within 6 weeks after vaccination
Secondary Outcome Measure Information:
Title
the Immunogenicity of Skyvaricella Injection
Description
seroconversion rate by Fluorescent antibody to membrane antigens (FAMA) test
Time Frame
6 weeks after investigational vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Those who received or expected to receive steroids from 3 months prior to the IP vaccine to the 3rd visit (6 + 2 weeks after the IP vaccine) (However, in the case of steroid use Low doses [eg <2 mg Prednison / kg / day up to a maximum of 20 mg / day for <2 weeks], the patient can participate in the study if use can be suspended until 3rd Visit after getting the IP vaccine).
Persons who received or expected to receive antiretroviral drugs from 1 month prior to the IP vaccine to 3rd visits (6 weeks after vaccination + 2 weeks) during the clinical study period ( However, in the case of topical antiviral drugs, patients can participate in the study).
People who received or expected to receive other IPs in another clinical study from 1 month before the IP vaccine to the 3rd visit (6 + 2 weeks after the IP vaccine).
Others are considered ineligible to participate in research according to the researcher's judgment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pham N Hung, As. Prof.
Organizational Affiliation
Vietnam Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CDC Ha Nam
City
Phu Ly
State/Province
Ha Nam
ZIP/Postal Code
18000
Country
Vietnam
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety and Immunogenicity of Skyvaricella Injection in Healthy Volunteer Vietnamese Children From 12 Months to 12 Years Old
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