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

GC3107_P3

The purpose of this study is to investigate the efficacy and safety of GC3107 in healthy infants

2019-08-06

2022-06-20

2022-09-06

Completed

Early phase I

750

Inclusion Criteria: 1. Subject's legally acceptable representatives had this clinical trial information explained to them and understood it, voluntarily decided participation, and provided informed consent 2. Healthy infants aged≤4weeks 3. Body weight≥2,500g at birth 4. Born after normal gestation(≥37weeks) Exclusion Criteria: 1. Had contact with patients with a confirmed diagnosis of active pulmonary tuberculosis 2. Any symptoms or signs of active tuberculosis infection or current treatment of tuberculosis at screening 3. History of confirmed tuberculosis 4. 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 5. Hypothermia with tympanic temperature\<36.0 'C within 24 hours prior to administration of the investigational product 6. Clinically suspected neonatal sepsis 7. Born with severe congenital anomaly that may affect the efficacy or safety result of this clinical trial as judged by the investigator 8. Severe skin disease or burn at the injection site of investigational product 9. The subject's mother had human immunodeficiency virus (HIV)-positive result on prenatal testing

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2022-11-02