A Phase 2 interventional study of MG1111 (BARICELA) and VARIVAX in Varicella, sponsored by Green Cross Corporation. Recruiting at 1 site in Korea, Republic of. Open to participants aged 4 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-24.
Sponsored by Green Cross Corporation · Phase 2, Interventional, and Other
Safety
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
180 studies on the registry are indexed under Chickenpox; 28 are open to participants now.
This study's planned enrollment of 230 is below the median of 475 across 149 interventional studies indexed under Chickenpox.
Browse Chickenpox studies →Green Cross Corporation is the lead sponsor of 63 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
0.5ml, single dose, subcutaneous injection
Biological: MG1111 (BARICELA)
0.5ml, single dose, subcutaneous injection
Biological: VARIVAX
0.5ml, single dose, subcutaneous injection
Biological: Suduvax
0.5ml, single dose, subcutaneous injection
0.5ml, single dose, subcutaneous injection
0.5ml, single dose, subcutaneous injection
Incidence of fever (temperature ≥39.0℃)
Incidence of fever (temperature ≥39.0℃) within 7days after the IP administration
Time frame: within 7 days
Solicited local / systemic adverse events
Solicited local / systemic adverse events that occurred within 7 days after the IP administration
Time frame: within 7 days
Unsolicited adverse events
Unsolicited adverse events that occurred within 42 days after the IP administration
Time frame: 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.
Time frame: within 42 days
Incidence of fever (temperature ≥39.0℃)
Incidence of fever (temperature ≥39.0℃) within 42 days after the IP administration
Time frame: 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.
Time frame: within 42 days
Serious adverse events
Serious adverse events that occurred within 1 year after the IP administration
Time frame: 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
Time frame: at Day1, Day42
GMV and GMR of VZV-CMI response
GMV and GMR of VZV-CMI response measured by INF-r ELISPOT at before and 42 days after the IP administration
Time frame: at Day1, Day42
GMT and GMR of the antibody titer
GMT and GMR of the antibody titer measured by gpELISA at before and after the IP administration for 3 year
Time frame: at Year1, Year2, Year3
Varicella-like rash
Varicella-like rash occurred after IP administration for 3 years
Time frame: anytime within 3 years (if applicable)
Varicella-zoster virus genotyping
Varicella-zoster virus genotyping analysis occurred after IP administration for 3 years
Time frame: anytime within 3 years (if applicable)
Started Jul 2022 (actual). Primary completion is estimated for Jun 2025, 35 months after the start.
Of 17 phase 2 interventional studies under Chickenpox, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 38. This study's planned 35 months is above that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: MG1111