BCG Vaccination ReactionPhase 3NCT03947138
A Study of GC3107(BCG Vaccine) in Healthy Infants
A Phase 3 study testing GC3107 and Intradermal BCG SSI inj. in people with BCG Vaccination Reaction and Tuberculosis, run by Green Cross Corporation at 2 sites in South Korea.
Trial summary
The purpose of this study is to investigate the efficacy and safety of GC3107 in healthy infants Read more about this study
- Who is it for?
- Ages Up to 4 weeksHealthy volunteers can take part
- Conditions the study is for
- BCG Vaccination Reaction, Tuberculosis
- What is being tested?
- GC3107 and Intradermal BCG SSI inj.
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 6 Aug 2019to 6 Sep 2022
- Phase
- Phase 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 Up to 4 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subject's legally acceptable representatives had this clinical trial information explained to them and understood it, voluntarily decided participation, and provided informed consent
- Healthy infants aged≤4weeks
- Body weight≥2,500g at birth
- Born after normal gestation(≥37weeks)
Who cannot join
- Had contact with patients with a confirmed diagnosis of active pulmonary tuberculosis
- Any symptoms or signs of active tuberculosis infection or current treatment of tuberculosis at screening
- History of confirmed tuberculosis
- Acute fever with tympanic temperature≥38.0 'C within 24 hours prior to administration of the investigational product, or an active infections disease at screening
- Hypothermia with tympanic temperature<36.0 'C within 24 hours prior to administration of the investigational product
- Clinically suspected neonatal sepsis
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- Born with severe congenital anomaly that may affect the efficacy or safety result of this clinical trial as judged by the investigator
- Severe skin disease or burn at the injection site of investigational product
- The subject's mother had human immunodeficiency virus (HIV)-positive result on prenatal testing
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
The Catholic Universitiy of Korea St. vincent's Hospital
Suwon
Greencross
Yŏngin
About this study
Official title: A Multi-national, Multi-center, Randomized, Double-Blind, Active-Controlled, Phase III Study to Investigate the Efficacy and Safety of 'GC3107(BCG Vaccine)' After Intradermal Administration in Healthy Infants
The purpose of this study is to investigate the efficacy and safety of GC3107 in healthy infants
Read the detailed description
The study will be conducted in 2 Countries, Korea and Thailand. About 750 subjects will be enrolled to this study.
This clinical trial consists of Part 1 to compare the efficacy and safety between the study group and the active control group and Part 2 for the final safety assessment. Subject enrollment for Part 1 and Part 2 will occur at the same time, and subjects who meet the final inclusion/exclusion criteria will be randomized to Part 1 or Part 2 via the IWRS.
When the legally acceptable representative of the subject within 4 weeks after birth consents to participate in the clinical study in writing at Visit 1, the protocol-mandated examination and tests will be performed at each visit, and only the subjects who meet the inclusion/exclusion criteria will be assigned randomization numbers and receive a single intradermal injection of the investigational product. However, the informed consent of the subject's legally acceptable representative for participation in the clinical trial may be obtained between 36 weeks of pregnancy of a subject's mother and Visit 1.
The investigator will instruct the subject's legally acceptable representative to record any adverse events (AEs) occurring after administration of the investigational product to assess the safety of the subject during the study period.
The subjects participating in Part 1 will have the tuberculin skin test at Visit 4 for the efficacy assessment and receive an intradermal injection of 0.1 mL purified protein derivatives (PPD) reagent. Visit 5 will occur within 48 to 72 hours of the PPD reagent injection to check the tuberculin skin test results.
Also, Visit 6 will be conducted as an on-site visit to check for any solicited local AEs (abscess, ulcer, scar, and BCG lymphadenitis) and unsolicited AEs occurring until 6 months (168 days) after administration of the investigational product.
- Conditions
- BCG Vaccination Reaction, Tuberculosis
- Being tested
- GC3107, Intradermal BCG SSI inj.
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC3107Biological
BCG Vaccine
Intradermal BCG SSI inj.Biological
BCG Vaccine
| Study group | Role | What they receive |
|---|---|---|
| GC3107_Part1 | Experimental | Part 1 GC3107(BCG Vaccine) Single intradermal Injection of 0.05 mL into the end of deltoid muscle in outer aspect of upper arm Receives: Biological: GC3107 |
| GC3107_Part2 | Experimental | Part 2 GC3107(BCG Vaccine) Single intradermal Injection of 0.05 mL into the end of deltoid muscle in outer aspect of upper arm Receives: Biological: GC3107 |
| BCG SSI_Part1 | Active comparator | Part 1 Intradermal BCG SSI inj Single intradermal Injection of 0.05 mL into the end of deltoid muscle in outer aspect of upper arm Receives: Biological: Intradermal BCG SSI inj. |
| BCG SSI_Part2 | Active comparator | Part 2 Intradermal BCG SSI inj Single intradermal Injection of 0.05 mL into the end of deltoid muscle in outer aspect of upper arm Receives: Biological: Intradermal BCG SSI inj. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with maximum diameter of induration ≥ 5mm in the tuberculin skin test
Induration diameter measured in the direction perpendicular to the arm.
Measured: 84 days after administration of the investigational product
Secondary outcomes (2)
Proportion of subjects with maximum diameter of induration <5mm, ≥ 5mm to <10mm and ≥10mm in the tuberculin skin test
Induration diameter measured in the direction perpendicular to the arm.
Measured: 84 days after administration of the investigational product
Proportion of subjects with maximum diameter of erythema ≥ 5mm in the tuberculin skin test
Erythema diameter measured in the direction perpendicular to the arm.
Measured: 84 days after administration of the investigational product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start6 Aug 2019
- Primary completion20 Jun 2022
- Study completion6 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BCG Vaccination ReactionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JongHyun Kim, MD, Principal investigator, The Catholic University of Korea St. Vincent's Hospital, Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947138
- Sponsor's protocol ID
- GC3107_P3
- Status last verified
- Oct 2022
- First submitted
- 29 Apr 2019
- Last updated
- 2 Nov 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 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-national, Multi-center, Randomized, Double-Blind, Active-Controlled, Phase III Study to Investigate the Efficacy and Safety of 'GC3107(BCG Vaccine)' After Intradermal Administration in Healthy Infants
- ClinicalTrials.gov ID
- NCT03947138
- Acronym / sponsor ID
- GC3107_P3
- Conditions
- BCG Vaccination Reaction, Tuberculosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 6 Sep 2022 (actual)
- First posted
- 13 May 2019 (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 purpose of this study is to investigate the efficacy and safety of GC3107 in healthy infants
Detailed description
The study will be conducted in 2 Countries, Korea and Thailand. About 750 subjects will be enrolled to this study.
This clinical trial consists of Part 1 to compare the efficacy and safety between the study group and the active control group and Part 2 for the final safety assessment. Subject enrollment for Part 1 and Part 2 will occur at the same time, and subjects who meet the final inclusion/exclusion criteria will be randomized to Part 1 or Part 2 via the IWRS.
When the legally acceptable representative of the subject within 4 weeks after birth consents to participate in the clinical study in writing at Visit 1, the protocol-mandated examination and tests will be performed at each visit, and only the subjects who meet the inclusion/exclusion criteria will be assigned randomization numbers and receive a single intradermal injection of the investigational product. However, the informed consent of the subject's legally acceptable representative for participation in the clinical trial may be obtained between 36 weeks of pregnancy of a subject's mother and Visit 1.
The investigator will instruct the subject's legally acceptable representative to record any adverse events (AEs) occurring after administration of the investigational product to assess the safety of the subject during the study period.
The subjects participating in Part 1 will have the tuberculin skin test at Visit 4 for the efficacy assessment and receive an intradermal injection of 0.1 mL purified protein derivatives (PPD) reagent. Visit 5 will occur within 48 to 72 hours of the PPD reagent injection to check the tuberculin skin test results.
Also, Visit 6 will be conducted as an on-site visit to check for any solicited local AEs (abscess, ulcer, scar, and BCG lymphadenitis) and unsolicited AEs occurring until 6 months (168 days) after administration of the investigational product.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GC3107_Part1 | Experimental | Biological: GC3107Part 1 GC3107(BCG Vaccine) Single intradermal Injection of 0.05 mL into the end of deltoid muscle in outer aspect of upper arm |
| GC3107_Part2 | Experimental | Biological: GC3107Part 2 GC3107(BCG Vaccine) Single intradermal Injection of 0.05 mL into the end of deltoid muscle in outer aspect of upper arm |
| BCG SSI_Part1 | Active comparator | Biological: Intradermal BCG SSI inj.Part 1 Intradermal BCG SSI inj Single intradermal Injection of 0.05 mL into the end of deltoid muscle in outer aspect of upper arm |
| BCG SSI_Part2 | Active comparator | Biological: Intradermal BCG SSI inj.Part 2 Intradermal BCG SSI inj Single intradermal Injection of 0.05 mL into the end of deltoid muscle in outer aspect of upper arm |
Who may qualify
- Ages
- Up to 4 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Subject's legally acceptable representatives had this clinical trial information explained to them and understood it, voluntarily decided participation, and provided informed consent
- Healthy infants aged≤4weeks
- Body weight≥2,500g at birth
- Born after normal gestation(≥37weeks)
Key exclusion criteria (9 listed)
- Had contact with patients with a confirmed diagnosis of active pulmonary tuberculosis
- Any symptoms or signs of active tuberculosis infection or current treatment of tuberculosis at screening
- History of confirmed tuberculosis
- Acute fever with tympanic temperature≥38.0 'C within 24 hours prior to administration of the investigational product, or an active infections disease at screening
- Hypothermia with tympanic temperature<36.0 'C within 24 hours prior to administration of the investigational product
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 |
|---|---|---|
| GC3107BCG Vaccine | Biological | GC3107_Part1, GC3107_Part2 |
| Intradermal BCG SSI inj.BCG Vaccine | Biological | BCG SSI_Part1, BCG SSI_Part2 |
Primary outcome
Proportion of subjects with maximum diameter of induration ≥ 5mm in the tuberculin skin test
Time frame: 84 days after administration of the investigational product
Induration diameter measured in the direction perpendicular to the arm.
2 secondary outcomes
Proportion of subjects with maximum diameter of induration <5mm, ≥ 5mm to <10mm and ≥10mm in the tuberculin skin test
Time frame: 84 days after administration of the investigational product
Proportion of subjects with maximum diameter of erythema ≥ 5mm in the tuberculin skin test
Time frame: 84 days after administration of the investigational product
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 2 Nov 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.
JongHyun Kim, MD principal investigator
The Catholic University of Korea St. Vincent's Hospital, Pediatrics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GC3107 and Intradermal BCG SSI inj. in people with BCG Vaccination Reaction and Tuberculosis, run by Green Cross Corporation at 2 sites 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 9 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 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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 with maximum diameter of induration ≥ 5mm in the tuberculin skin test (time frame: 84 days after administration of the investigational product). 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 2 Nov 2022.