CompletedPhase 2

Safety and Tuberculin Conversion Following BCG Vaccination

Indonesia220 participantsStarted 2021-12-01

Plain-language summary

The study is an bridging study, observer-blind, randomized, controlled prospective intervention study. The primary objective is evaluate the safety of BCG Vaccine Vial (Bio Farma).

Who can participate

Age range1 Day – 1 Month

SexALL

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

Inclusion criteria

✓. Healthy infant aged 0-1 month.
✓. Infants born after 37-42 weeks of pregnancy.
✓. Infant weighing 2500 gram or more at birth.
✓. Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
✓. Parents will commit themselves to comply with the instructions of the investigator and with the schedule of the trial.

Exclusion criteria

✕. Child concomitantly enrolled or scheduled to be enrolled in another trial.
✕. Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature 37.5 celcius degrees).
✕. Suspected of allergy to any component of the vaccines.
✕. Newborn suspected of congenital or acquired immunodeficiency.
✕. Received or plans to receive any treatment likely to alter the immune response intravenous (immunoglobulins, blood-derived products or long term corticotherapy (\> 2 weeks)).
✕. Received other vaccination with the exception of OPV and Hepatitis B vaccine.
✕. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
✕. Any skin disease such eczema generalisata other skin infection which makes difficult the assessment of the local reactios.

What they're measuring

To evaluate the safety of BCG Vaccine Vial (Bio Farma)

Timeframe: 30 minutes after vaccination

Trial details

NCT IDNCT05124340

SponsorPT Bio Farma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-31

View on ClinicalTrials.gov More BCG Vaccination Reaction trials