Varicella Zoster Virus InfectionNCT05664152
An Open-label, Bridging Study of BARYCELA Inj. in Healthy Vietnamese Children Aged Between 12 Months to 12 Years
A study testing MG1111 in people with Varicella Zoster Virus Infection, run by GC Biopharma Corp.
Trial summary
The goal of this bridging study is to assess the safety and immunogenicity of BARYCELA inj. in healthy Vietnamese children aged between 12 months to 12 years. The main questions it aims to answer are: Safety of BARYCELA inj. (Live attenuated varicella vaccine for injection) Immunogenicity of BARYCELA inj. Read more about this study
- Who is it for?
- Ages 12 months to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Varicella Zoster Virus Infection
- What is being tested?
- MG1111
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Jun 2023
- Phase
- Interventional
- 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
- Healthy children aged 12 months to 12 years (inclusive)
- Subject parent/legal representative willing to provide written informed consent and able to comply with the requirements for the study - Subject able to attend all scheduled visits and to comply with all study procedures
- Negative history of Varicella and varicella vaccine
- Subject in good health, based on medical history and physical examination
- Having a readily identifiable place of residence in the study area, being available for the duration of trial participation, with means of telephone contact.
Who cannot join
- Subjects who have a history of Varicella or administration of varicella vaccine
- Subjects who have hypersensitivity reactions to the component of this Investigational Product, such as gelatin
- Subjects with untreated active tuberculosis
- Subjects with a history of Guillain-Barre syndrome
- Subjects who had received salicylates (aspirin, bismuth subsalicylates) within 4 weeks before administration of investigational product or those who are planning to receive salicylates within 42 days after administration of investigational drug.
- Subjects who administered anti-viral drug within 4 weeks before administration of investigational product or those who are planning to receive anti-viral drug within 42 days after administration of investigational drug.
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- Subjects who have had an acute febrile episode (at least 38.00C) at some time during the 72 hours before administration of investigational product or those who had any symptom suspected to be allergy including systemic rash.
- Currently receiving or received any investigational intervention within 30 days prior to the vaccination of study vaccine.
- Subjects who have completed vaccinations within 4 weeks before enrolment or who are planning to administer other vaccines within 42 days after administration of investigational product.
- Administered any blood product or intravenous immunoglobulin administration within 44 weeks prior to the vaccination of study intervention
- Currently receiving or anticipate to receive concomitant immunosuppressive or immune-modifying therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or < 2 weeks of daily receipt of prednisone less than 20 mg for subjects who weight more than 10kg and less than 2mg/kg/day for subjects who weight less than 10kg, or equivalent) within 12 weeks prior to the vaccination of study vaccine.
- Immunosuppressive illness or immunodeficient state, including hematologic malignancy, history of solid organ, bone marrow transplantation, or asplenia.
- Subject with a history of hypersensitivity to any vaccine or a history of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.
- Subjects with a severe chronic disease or other clinically significant medical or psychological condition who are considered by the Investigator to be ineligible for the study.
- Subjects who are pregnant or lactating at the day of screening.
- Subjects who are planned to participate in another clinical trial during the present trial period.
About this study
Official title: An Open-label, Bridging Study to Assess the Safety and Immunogenicity of BARYCELA Inj. (Live Attenuated Varicella Vaccine for Injection) in Healthy Vietnamese Children Aged Between 12 Months to 12 Years
The goal of this bridging study is to assess the safety and immunogenicity of BARYCELA inj. in healthy Vietnamese children aged between 12 months to 12 years. The main questions it aims to answer are:
- Safety of BARYCELA inj. (Live attenuated varicella vaccine for injection)
- Immunogenicity of BARYCELA inj. (Live attenuated varicella vaccine for injection)
Participants will be administered subcutaneously with a single dose(0.5 mL dose) of the BARYCELA inj.(MG1111) on the upper arm (brachia lateral).
- Conditions
- Varicella Zoster Virus Infection
- Being tested
- MG1111
- Keywords
- MG1111, Varicella
- Medical subject headings
- Varicella Zoster Virus Infection, Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MG1111Biological
BARYCELA inj.
| Study group | Role | What they receive |
|---|---|---|
| MG1111 | Experimental | Participants will be administered subcutaneously with a single dose(0.5 mL dose) of the BARYCELA inj.(MG1111) on the upper arm (brachia lateral). Receives: Biological: MG1111 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of BARYCELA inj.: Solicited local and systemic reactogenicity
The incidence and severity of immediate solicited local and systemic reactogenicity
Measured: within 30-minute post vaccination
Safety of BARYCELA inj.: The incidence and severity of solicited local and systemic AEs
The incidence and severity of solicited local and systemic AEs
Measured: during 7 days post vaccination
Safety of BARYCELA inj.: Incidence and severity of unsolicited AEs
The incidence and severity of unsolicited AEs
Measured: during 42 days post vaccination
Safety of BARYCELA inj.: Incidence of adverse event of special interest
The incidence of AE of Special Interest (AESI): varicella-like rash.
Measured: during 42 days post vaccination
Safety of BARYCELA inj.: Vital signs
Vital signs
Measured: Day0(Pre vaccination), 42 days post vaccination
Safety of BARYCELA inj.: Body temperature
Body temperature; measured according to standard of care and thermometer instructions.
Measured: Day0(Pre vaccination), 42 days post vaccination
Safety of BARYCELA inj.: Complete physical examination
Complete physical examination; performed at Screening/Enrollment (Day 0) and Final Visit(Day 42).
Measured: Day0(Pre vaccination), 42 days post vaccination
Safety of BARYCELA inj.: Symptom-directed physical examination
Symptom-directed physical examination (if any symptoms); performed at other timepoints as indicated to assess changes from Screening
Measured: Day0(Pre vaccination), during 42 days post vaccination
Secondary outcomes (2)
Immunogenicity of BARYCELA inj.: Geometric Mean Titer (GMT)
Geometric Mean Titer (GMT) of antibody titer measured with gpELISA
Measured: Prior to IP administration and 42 days post vaccination
Immunogenicity of BARYCELA inj.: Geometric Mean Fold Rise (GMFR)
Geometric Mean Fold Rise (GMFR)
Measured: Prior to IP administration and 42 days post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study startFeb 2023 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicella Zoster Virus InfectionStudies of the same condition, open and under way.
- More trials run by GC Biopharma CorpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GC Biopharma Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664152
- Sponsor's protocol ID
- MG1111_VAR_P0302
- Status last verified
- Dec 2022
- First submitted
- 2 Dec 2022
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Bridging Study to Assess the Safety and Immunogenicity of BARYCELA Inj. (Live Attenuated Varicella Vaccine for Injection) in Healthy Vietnamese Children Aged Between 12 Months to 12 Years
- ClinicalTrials.gov ID
- NCT05664152
- Acronym / sponsor ID
- MG1111_VAR_P0302
- Conditions
- Varicella Zoster Virus Infection
- Keywords
- MG1111, Varicella
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- GC Biopharma CorpIndustry (pharma, biotech, devices)
- Study start
- Feb 2023 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 23 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this bridging study is to assess the safety and immunogenicity of BARYCELA inj. in healthy Vietnamese children aged between 12 months to 12 years. The main questions it aims to answer are:
- Safety of BARYCELA inj. (Live attenuated varicella vaccine for injection)
- Immunogenicity of BARYCELA inj. (Live attenuated varicella vaccine for injection)
Participants will be administered subcutaneously with a single dose(0.5 mL dose) of the BARYCELA inj.(MG1111) on the upper arm (brachia lateral).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MG1111 | Experimental | Biological: MG1111Participants will be administered subcutaneously with a single dose(0.5 mL dose) of the BARYCELA inj.(MG1111) on the upper arm (brachia lateral). |
Who may qualify
- Ages
- 12 months to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy children aged 12 months to 12 years (inclusive)
- Subject parent/legal representative willing to provide written informed consent and able to comply with the requirements for the study - Subject able to attend all scheduled visits and to comply with all study procedures
- Negative history of Varicella and varicella vaccine
- Subject in good health, based on medical history and physical examination
- Having a readily identifiable place of residence in the study area, being available for the duration of trial participation, with means of telephone contact.
Key exclusion criteria (16 listed)
- Subjects who have a history of Varicella or administration of varicella vaccine
- Subjects who have hypersensitivity reactions to the component of this Investigational Product, such as gelatin
- Subjects with untreated active tuberculosis
- Subjects with a history of Guillain-Barre syndrome
- Subjects who had received salicylates (aspirin, bismuth subsalicylates) within 4 weeks before administration of investigational product or those who are planning to receive salicylates within 42 days after administration of investigational drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MG1111BARYCELA inj. | Biological | MG1111 |
Primary outcome
Safety of BARYCELA inj.: Solicited local and systemic reactogenicity
Time frame: within 30-minute post vaccination
The incidence and severity of immediate solicited local and systemic reactogenicity
Safety of BARYCELA inj.: The incidence and severity of solicited local and systemic AEs
Time frame: during 7 days post vaccination
The incidence and severity of solicited local and systemic AEs
Safety of BARYCELA inj.: Incidence and severity of unsolicited AEs
Time frame: during 42 days post vaccination
The incidence and severity of unsolicited AEs
Safety of BARYCELA inj.: Incidence of adverse event of special interest
Time frame: during 42 days post vaccination
The incidence of AE of Special Interest (AESI): varicella-like rash.
Safety of BARYCELA inj.: Vital signs
Time frame: Day0(Pre vaccination), 42 days post vaccination
Vital signs
Safety of BARYCELA inj.: Body temperature
Time frame: Day0(Pre vaccination), 42 days post vaccination
Body temperature; measured according to standard of care and thermometer instructions.
Safety of BARYCELA inj.: Complete physical examination
Time frame: Day0(Pre vaccination), 42 days post vaccination
Complete physical examination; performed at Screening/Enrollment (Day 0) and Final Visit(Day 42).
Safety of BARYCELA inj.: Symptom-directed physical examination
Time frame: Day0(Pre vaccination), during 42 days post vaccination
Symptom-directed physical examination (if any symptoms); performed at other timepoints as indicated to assess changes from Screening
2 secondary outcomes
Immunogenicity of BARYCELA inj.: Geometric Mean Titer (GMT)
Time frame: Prior to IP administration and 42 days post vaccination
Immunogenicity of BARYCELA inj.: Geometric Mean Fold Rise (GMFR)
Time frame: Prior to IP administration and 42 days post vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing MG1111 in people with Varicella Zoster Virus Infection, run by GC Biopharma Corp.
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 5 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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?
Safety of BARYCELA inj.: Solicited local and systemic reactogenicity (time frame: within 30-minute post vaccination). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2022.