Safety and Tuberculin Conversion Following BCG Vaccination

PT Bio Farma

Status and phase: Completed; Phase 2

Conditions: BCG Vaccination Reaction

Treatments: Biological: BCG ampoule vaccine; Biological: BCG vial vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05124340

BS BCG 0221

Details and patient eligibility

About

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).

Full description

This trial is bridging study, observer blinded, comparative, randomized study. Approximately 220 subjects will be recruited, 110 subjects are the investigational arm and 110 subjects are the active comparator arm.

The objective of the study is to evaluate the safety of BCG Vaccine Vial (Bio Farma), and assess the the local and systemic reactions within 90 days after vaccination in each group, and assess the tuberculin conversion in each group.

Enrollment: 220 patients

Sex: All

Ages: 1 day to 1 month old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Child concomitantly enrolled or scheduled to be enrolled in another trial.
2. Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature 37.5 celcius degrees).
3. Suspected of allergy to any component of the vaccines.
4. Newborn suspected of congenital or acquired immunodeficiency.
5. Received or plans to receive any treatment likely to alter the immune response intravenous (immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks)).
6. Received other vaccination with the exception of OPV and Hepatitis B vaccine.
7. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
8. Any skin disease such eczema generalisata other skin infection which makes difficult the assessment of the local reactios.
9. Mothers with HbsAg and HIV positive (by rapid test)
10. Parents planning to move from the study area before the end of study period.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 2 patient groups

Vaccine

Experimental group

Description:

1 dose of BCG vial vaccine injected in right deltoid armintradermally

Treatment:

Biological: BCG vial vaccine

Active Comparator

Active Comparator group

Description:

1 dose of BCG ampoule vaccine injected in right deltoid arm intradermally

Treatment:

Biological: BCG ampoule vaccine