Healthy ChildrenPhase 2/3NCT03375502
A Study of MG1111 in Healthy Children
A Phase 2/3 study testing Varicella Vaccine in people with Healthy Children, run by Green Cross Corporation at 1 site in South Korea.
Trial summary
To assess the safety of MG1111 and to evaluate immunological non-inferiority of MG1111 versus comparator Read more about this study
- Who is it for?
- Ages 12 months to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Children
- What is being tested?
- Varicella Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 814 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Nov 2016to 31 Jul 2019
- Phase
- Phase 2/3
- 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.
- Subjects or 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
Who cannot join
- Subjects who have a history of Varicella or administration of varicella vaccine
- Subjects who have ahd an acute febrile episode 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The catholic university of Korea, Seoul st. mary's hospital
Banpo-dong, Seoul
About this study
Official title: A Phase II/III, Single-blind(Stage 1), Double-blinded(Stage 2), Randomized, Active-controlled, Dose-escalation(Stage 1), Non-inferiority(Stage 2) Study to Evaluate Immunogenicity and Safety of MG1111 in Healthy Children
To assess the safety of MG1111 and to evaluate immunological non-inferiority of MG1111 versus comparator
- Conditions
- Healthy Children
- Being tested
- Varicella Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varicella VaccineDrug
Also called vaccination
The subject will receive investigational product or comparator.
| Study group | Role | What they receive |
|---|---|---|
| MG1111(Varicella vaccine) | Experimental | A single injection of 0.5ml MG1111 will be administered subcutaneously at Visit 1 Receives: Drug: Varicella Vaccine |
| Comparator(Varicella vaccine) | Active comparator | A single injection of 0.5ml comparator will be administered subcutaneously at Visit 1 Receives: Drug: Varicella Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who achieved seroconversion
Measured: 42 days after vaccination
Secondary outcomes (2)
Geometric mean titer(GMT) measured by the FAMA assay
Measured: At day 0 and Day 42 post-vaccination
Geometric mean titer(GMT) measured by gpELISA
Measured: At day 0 and Day 42 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start26 Nov 2016
- Primary completion29 Jan 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ChildrenStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 814 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375502
- Sponsor's protocol ID
- MG1111_P2/3
- Status last verified
- Dec 2017
- First submitted
- 28 Nov 2017
- Last updated
- 14 May 2021
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III, Single-blind(Stage 1), Double-blinded(Stage 2), Randomized, Active-controlled, Dose-escalation(Stage 1), Non-inferiority(Stage 2) Study to Evaluate Immunogenicity and Safety of MG1111 in Healthy Children
- ClinicalTrials.gov ID
- NCT03375502
- Acronym / sponsor ID
- MG1111_P2/3
- Conditions
- Healthy Children
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 814 participants (actual)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2016 (actual)
- Primary completion
- 29 Jan 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 18 Dec 2017 (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.
To assess the safety of MG1111 and to evaluate immunological non-inferiority of MG1111 versus comparator
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MG1111(Varicella vaccine) | Experimental | Drug: Varicella VaccineA single injection of 0.5ml MG1111 will be administered subcutaneously at Visit 1 |
| Comparator(Varicella vaccine) | Active comparator | Drug: Varicella VaccineA single injection of 0.5ml comparator will be administered subcutaneously at Visit 1 |
Who may qualify
- Ages
- 12 months to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy children aged 12 months to 12 years.
- Subjects or 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
Key exclusion criteria (2 listed)
- Subjects who have a history of Varicella or administration of varicella vaccine
- Subjects who have ahd an acute febrile episode 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.
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 |
|---|---|---|
| Varicella VaccineAlso: vaccinationThe subject will receive investigational product or comparator. | Drug | Comparator(Varicella vaccine), MG1111(Varicella vaccine) |
Primary outcome
Proportion of subjects who achieved seroconversion
Time frame: 42 days after vaccination
2 secondary outcomes
Geometric mean titer(GMT) measured by the FAMA assay
Time frame: At day 0 and Day 42 post-vaccination
Geometric mean titer(GMT) measured by gpELISA
Time frame: At day 0 and Day 42 post-vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Varicella Vaccine in people with Healthy Children, 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 2 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 14 May 2021. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Proportion of subjects who achieved seroconversion (time frame: 42 days after vaccination). 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 14 May 2021.