A Study of GC3107(BCG Vaccine) in Healthy Infants (NCT03947138) | Clinical Trial Compass
CompletedPhase 3
A Study of GC3107(BCG Vaccine) in Healthy Infants
South Korea750 participantsStarted 2019-08-06
Plain-language summary
The purpose of this study is to investigate the efficacy and safety of GC3107 in healthy infants
Who can participate
Age range
4 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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)
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of subjects with maximum diameter of induration ≥ 5mm in the tuberculin skin test
Timeframe: 84 days after administration of the investigational product