VaricellaPhase 2NCT05422508
Evaluate the Safety and Immunogenicity After MG1111(BARICELA Inj.) as 2nd Vaccination in 4 ~ 6 Year Old Healthy Children With a History of 1st Varicella Vaccination
A Phase 2 study testing MG1111 (BARICELA), VARIVAX and Suduvax in people with Varicella, run by Green Cross Corporation at 1 site in South Korea.
Trial summary
Primary objective is to assess the safety of MG1111 until Day 42 using as 2nd vaccination Secondary objective to assess the immunogenicity and safety of MG1111 using as 2nd vaccination Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Varicella
- What is being tested?
- MG1111 (BARICELA), VARIVAX and Suduvax
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Jul 2022to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children between 4 and 6 years of age as of the date of written consent
- Subjects who have a history of 1st Varicella vaccination at least 3 years ago from the administration of investigational product
- Subjects or parent/legal representative willing to provide written informed consent and able to comply with the study requirements
- Negative history of Varicella infection
Who cannot join
- Subjects with a history of exposure to varicella through contact with a varicella patient at home, school, or childcare facility within 4 weeks before the administration of investigational drug
- Subjects who have a history 2 times or more of varicella vaccine injections
- Subjects who had an acute febrile (at least 38.0 ℃) episode at some time during the 72 hours before the administration of investigational product
- Subjects who had any suspected allergy symptoms including systemic rash during the 72 hours before the administration of investigational product
- Subjects with a history of Guillain-Barre syndrome.
- Subjects with a severe chronic disease and considered ineligible for the study at Investigator's discretion
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- Subjects with a history of hypersensitivity to any ingredient such as gelatin, antibiotics (Neomycin, Kanamycin, Erythromycin)
- Active tuberculosis patient
- Subjects who had received other vaccinations within 4 weeks before the administration of investigational product
- Subjects with immunodeficiency history
- Subjects who had received salicylates (aspirin, bismuth, subsalicylates) within 4 weeks before the administration of investigational drug
- Subjects who administered immune globulin, gamma globulin, or blood products such as whole blood within 44 weeks before the administration of investigational drug
- Subjects who had received immunosuppressant or immune modifying drug within 12 weeks before the administration of investigational drug
- A. Azathioprine, Cyclosporin, Interferon, G-CSF, Tacrolimus, Everolimus, Sirolimus, etc.
- B. Subjects who administered high dose of corticosteroids (greater than 2 mg/kg/day in case of under 10kg subjects or ≥20mg/day in case of above 10kg subject of prednisone for 14 days) (However, inhaled, intranasal, topical corticosteroids administration in allowed)
- Subjects who administered anti-viral drug within 4 weeks before the administration of investigational drug
- Subjects who have participated in any other clinical trials within 24 weeks of the administration of the investigational product
- Subjects with other clinically significant medical or psychological condition who are considered by the Investigator to be ineligible for the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Ansan Hospital
Ansan
About this study
Official title: A Double-blind, Randomized, Multi-Center, Active Controlled Phase 2 Clinical Trial to Evaluate the Safety and Immunogenicity After MG1111(BARICELA Inj.) as 2nd Vaccination in 4 ~ 6 Year Old Healthy Children With a History of 1st Varicella Vaccination
- Primary objective is to assess the safety of MG1111 until Day 42 using as 2nd vaccination
- Secondary objective to assess the immunogenicity and safety of MG1111 using as 2nd vaccination
Read the detailed description
- Safety
- Incidence of fever (temperature ≥39.0℃) within 42 days after the IP administration
- Incidence of fever (temperature ≥39.0℃) within 7 days after the IP administration
- Solicited local/systemic AEs occurred within 7 days after the IP administration
- Unsolicited adverse events that occurred within 42 days after the IP administration
- Serious adverse events that occurred within 1 year after the IP administration
- Vital signs and physical examinations
- Efficacy (Immunogenicity) -GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio(fold change))measured by the glycoprotein enzyme-linked immunosorbent assay (gpELISA) at before and 42 days after the IP administration
- Exploratory assessment
- GMV and GMR of VZV-CMI response measured by INF-r ELISPOT at before and 42 days after the IP administration
- GMT and GMR of the antibody titer measured by gpELISA at before and after the IP administration for 3 years
- Varicella-like rash and Varicella-zoster virus genotyping analysis occurred after IP administration for 3 years
- Conditions
- Varicella
- Being tested
- MG1111 (BARICELA), VARIVAX, Suduvax
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MG1111 (BARICELA)Biological
0.5ml, single dose, subcutaneous injection
VARIVAXBiological
0.5ml, single dose, subcutaneous injection
SuduvaxBiological
0.5ml, single dose, subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| MG1111(BARICELA) arm | Experimental | 0.5ml, single dose, subcutaneous injection Receives: Biological: MG1111 (BARICELA) |
| VARIVAX arm | Active comparator | 0.5ml, single dose, subcutaneous injection Receives: Biological: VARIVAX |
| Suduvax arm | Active comparator | 0.5ml, single dose, subcutaneous injection Receives: Biological: Suduvax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of fever (temperature ≥39.0℃)
Incidence of fever (temperature ≥39.0℃) within 7days after the IP administration
Measured: within 7 days
Solicited local / systemic adverse events
Solicited local / systemic adverse events that occurred within 7 days after the IP administration
Measured: within 7 days
Unsolicited adverse events
Unsolicited adverse events that occurred within 42 days after the IP administration
Measured: within 42 days
Vital signs (blood pressure, pulse rate, respiration rate and body temperature)
descriptive statistics (number of subjects, mean, standard deviation, median, minimum, and maximum) of change from baseline to 42 days will be presented for each group.
Measured: within 42 days
Incidence of fever (temperature ≥39.0℃)
Incidence of fever (temperature ≥39.0℃) within 42 days after the IP administration
Measured: within 42days
Physical examinations (Cardiovascular, respiratory, gastrointestinal, liver, metabolic/endocrine, kidney, reproductive, musculoskeletal and nervous system, head/neck, and skin)
the change from baseline to 42 days will be classified into 'normal/abnormal, not clinically significant (NCS)' or 'abnormal, clinically significant (CS)', and the frequency and percentage are presented in a shift table.
Measured: within 42 days
Secondary outcomes (2)
Serious adverse events
Serious adverse events that occurred within 1 year after the IP administration
Measured: within 1 year
GMT and GMR of the antibody titer
GMT and GMR of the antibody titer measured by gpELISA at before and 42 days after the IP administration
Measured: at Day1, Day42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start5 Jul 2022
- Primary completionJun 2025 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricellaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After the Protocol v4.1 was approved by Ministry of Food and Drug Safety (02Jun2023), Subject eligibility was change to 4 \~ 6 Year Old Healthy Children With a History of 1st Varicella Vaccination instead of 1st SUDUVAX inj. and Active Comparator: VARIVAX arm was deleted. \*VARIVAX release has been discontinued.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yun-kyung Kim, M.D., Ph.D, Principal investigator, Korea University Ansan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05422508
- Sponsor's protocol ID
- MG1111_VAR_P0201
- Status last verified
- Jan 2024
- First submitted
- 24 May 2022
- Last updated
- 24 Jan 2024
- 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 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Multi-Center, Active Controlled Phase 2 Clinical Trial to Evaluate the Safety and Immunogenicity After MG1111(BARICELA Inj.) as 2nd Vaccination in 4 ~ 6 Year Old Healthy Children With a History of 1st Varicella Vaccination
- ClinicalTrials.gov ID
- NCT05422508
- Acronym / sponsor ID
- MG1111_VAR_P0201
- Conditions
- Varicella
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 16 Jun 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.
- Primary objective is to assess the safety of MG1111 until Day 42 using as 2nd vaccination
- Secondary objective to assess the immunogenicity and safety of MG1111 using as 2nd vaccination
Detailed description
- Safety
- Incidence of fever (temperature ≥39.0℃) within 42 days after the IP administration
- Incidence of fever (temperature ≥39.0℃) within 7 days after the IP administration
- Solicited local/systemic AEs occurred within 7 days after the IP administration
- Unsolicited adverse events that occurred within 42 days after the IP administration
- Serious adverse events that occurred within 1 year after the IP administration
- Vital signs and physical examinations
- Efficacy (Immunogenicity) -GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio(fold change))measured by the glycoprotein enzyme-linked immunosorbent assay (gpELISA) at before and 42 days after the IP administration
- Exploratory assessment
- GMV and GMR of VZV-CMI response measured by INF-r ELISPOT at before and 42 days after the IP administration
- GMT and GMR of the antibody titer measured by gpELISA at before and after the IP administration for 3 years
- Varicella-like rash and Varicella-zoster virus genotyping analysis occurred after IP administration for 3 years
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- After the Protocol v4.1 was approved by Ministry of Food and Drug Safety (02Jun2023), Subject eligibility was change to 4 ~ 6 Year Old Healthy Children With a History of 1st Varicella Vaccination instead of 1st SUDUVAX inj. and Active Comparator: VARIVAX arm was deleted. *VARIVAX release has been discontinued.
| Arm | Type | Receives |
|---|---|---|
| MG1111(BARICELA) arm | Experimental | Biological: MG1111 (BARICELA)0.5ml, single dose, subcutaneous injection |
| VARIVAX arm | Active comparator | Biological: VARIVAX0.5ml, single dose, subcutaneous injection |
| Suduvax arm | Active comparator | Biological: Suduvax0.5ml, single dose, subcutaneous injection |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy children between 4 and 6 years of age as of the date of written consent
- Subjects who have a history of 1st Varicella vaccination at least 3 years ago from the administration of investigational product
- Subjects or parent/legal representative willing to provide written informed consent and able to comply with the study requirements
- Negative history of Varicella infection
Key exclusion criteria (18 listed)
- Subjects with a history of exposure to varicella through contact with a varicella patient at home, school, or childcare facility within 4 weeks before the administration of investigational drug
- Subjects who have a history 2 times or more of varicella vaccine injections
- Subjects who had an acute febrile (at least 38.0 ℃) episode at some time during the 72 hours before the administration of investigational product
- Subjects who had any suspected allergy symptoms including systemic rash during the 72 hours before the administration of investigational product
- Subjects with a history of Guillain-Barre syndrome.
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 |
|---|---|---|
| MG1111 (BARICELA)0.5ml, single dose, subcutaneous injection | Biological | MG1111(BARICELA) arm |
| VARIVAX0.5ml, single dose, subcutaneous injection | Biological | VARIVAX arm |
| Suduvax0.5ml, single dose, subcutaneous injection | Biological | Suduvax arm |
Primary outcome
Incidence of fever (temperature ≥39.0℃)
Time frame: within 7 days
Incidence of fever (temperature ≥39.0℃) within 7days after the IP administration
Solicited local / systemic adverse events
Time frame: within 7 days
Solicited local / systemic adverse events that occurred within 7 days after the IP administration
Unsolicited adverse events
Time frame: within 42 days
Unsolicited adverse events that occurred within 42 days after the IP administration
Vital signs (blood pressure, pulse rate, respiration rate and body temperature)
Time frame: within 42 days
descriptive statistics (number of subjects, mean, standard deviation, median, minimum, and maximum) of change from baseline to 42 days will be presented for each group.
Incidence of fever (temperature ≥39.0℃)
Time frame: within 42days
Incidence of fever (temperature ≥39.0℃) within 42 days after the IP administration
Physical examinations (Cardiovascular, respiratory, gastrointestinal, liver, metabolic/endocrine, kidney, reproductive, musculoskeletal and nervous system, head/neck, and skin)
Time frame: within 42 days
the change from baseline to 42 days will be classified into 'normal/abnormal, not clinically significant (NCS)' or 'abnormal, clinically significant (CS)', and the frequency and percentage are presented in a shift table.
2 secondary outcomes
Serious adverse events
Time frame: within 1 year
GMT and GMR of the antibody titer
Time frame: at Day1, Day42
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
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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.
Yun-kyung Kim, M.D., Ph.D principal investigator
Korea University Ansan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MG1111 (BARICELA), VARIVAX and Suduvax in people with Varicella, run by Green Cross Corporation at 1 site in South Korea.
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 18 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: looking for participants now, as of the sponsor's last update on 24 Jan 2024. 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 South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hye Won Shin (+82-31-260-9032, hwshin27@gccorp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of fever (temperature ≥39.0℃) (time frame: within 7 days). The study lists 6 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 24 Jan 2024.