BCG vaccines have been used worldwide since 1920s
Conditions
Interventions
to assess the safety and efficacy of test drug
(*Subjects will be assined to part 1),to compare the safety and efficacy of comparator with test drug in arm 1
(*Subjects will be assined to part 1),to a
GC3107,BCG Vaccine SSI,GC3107,BCG Vaccine SSI
Sponsors
Green Cross Coporation
CliPS
Eligibility
Sex/Gender
All
Age
0 Days to 4 Weeks
Inclusion criteria
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 ≤ 4 weeks 3)Body weight ≥2,500 g at birth 4)Born after normal gestation (≥37 weeks)
Exclusion criteria
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 (Visit 1) 3)History of confirmed tuberculosis 4)Acute fever with tympanic temperature ≥38.0 ℃ within 24 hours prior to administration of the investigational product, or an active infectious disease at screening (Visit 1) (However, subjects with tympanic temperature ≥38.0 ℃ within 24 hours prior to administration of the investigational product may be rescreened only once, and subjects with mild acute diseases such as mild fever, mild respiratory infection, otitis media, and diarrhea may be permitted to be vaccinated at the judgment of the investigator.) 5)Hypothermia with tympanic temperature 10 kg; Used continuously for ≥2 weeks. However, inhaled, intranasal or local administration of corticosteroids is permitted regardless of the dose used.) 13)History of other vaccines including BCG vaccine prior to screening (Visit 1), with an exception of Hepatitis B vaccine according to the national standard vaccination schedule
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with maximum diameter of induration ≥5 mm 48 -72 hrs post tuberculin skin test tuberculin skin test | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean maximum diameter of induration and erythema 48 -72 hrs post tuberculin skin test Tuberculin skin test ,Proportion of subjects with max diameter of induration and Eryth <5 mm, ≥5 mm to <10 mm, and ≥10 48 -72 hrs post tuberculin skin test Tuberculin skin test | — |
Countries
Thailand
Contacts
Public ContactGeoffrey Broadhead
Green Light Clinical
Outcome results
None listed