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ChickenpoxPhase 4NCT04384016

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

A Phase 4 study testing Skyvaricella Injection in people with Chickenpox, run by Vietnam Military Medical University at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 12 months to 12 yearsHealthy volunteers can take part
Conditions the study is for
Chickenpox
What is being tested?
Skyvaricella Injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
201 participants
Where
1 siteVietnam
Study dates
17 Apr 2021to 19 Apr 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 months to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

  • CDC Ha Nam

    Phu Ly, Ha Nam, 18000

Other trials in Vietnam

About this study

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

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:

Read more
  • 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.
Read the 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
Conditions
Chickenpox
Being tested
Skyvaricella Injection
Keywords
Chickenpox; varicella-zoster virus; varicella vaccine
Medical subject headings
Chickenpox

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Skyvaricella InjectionBiological

    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.

Study groups in NCT04384016
Study groupRoleWhat they receive
Evaluating the Safety of Skyvaricella Inj.ExperimentalThe 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
Receives: Biological: Skyvaricella Injection
Evaluating the Immunogenicity of Skyvaricella Inj.ExperimentalSecondary 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.
Receives: Biological: Skyvaricella Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the Safety of Skyvaricella Injection

    The incidence of a chickenpox-like local rash (injection site) or chickenpox-like rash (disseminated).

    Measured: between 1 and 6 weeks after vaccination

  2. the Safety of Skyvaricella Injection

    The incidence and severity of events (local and systemic)

    Measured: within 30 minutes after vaccination

  3. the Safety of Skyvaricella Inj.

    The incidence of expected systemic and local adverse events

    Measured: within 7 days after vaccination

  4. the Safety of Skyvaricella Injection

    The incidence of serious adverse events and Unexpected adverse events

    Measured: within 6 weeks after vaccination

Secondary outcomes (1)

  1. the Immunogenicity of Skyvaricella Injection

    seroconversion rate by Fluorescent antibody to membrane antigens (FAMA) test

    Measured: 6 weeks after investigational vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2020
  2. Study start17 Apr 2021
  3. Primary completion6 Jul 2021
  4. Study completion19 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04384016
Sponsor's protocol ID
VX.2019.08
Status last verified
Jul 2023
First submitted
2 May 2020
Last updated
6 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Skyvaricella Injection in people with Chickenpox, run by Vietnam Military Medical University at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the Safety of Skyvaricella Injection (time frame: between 1 and 6 weeks after vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04384016.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.

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