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

Age range4 Weeks

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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)

✕. 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
✕. 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

Proportion of subjects with maximum diameter of induration ≥ 5mm in the tuberculin skin test

Timeframe: 84 days after administration of the investigational product

NCT IDNCT03947138

SponsorGreen Cross Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-06-20