Safety and Tuberculin Conversion Following BCG Vaccination

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2022-07-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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BCG Vaccination Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Observer Blind : Investigational Product and Active Comparator are masking. Lot number is masking

Study Groups

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Vaccine

1 dose of BCG vial vaccine injected in right deltoid armintradermally

Group Type EXPERIMENTAL

BCG vial vaccine

Intervention Type BIOLOGICAL

Intradermal injection

Active Comparator

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

Group Type ACTIVE_COMPARATOR

BCG ampoule vaccine

Intervention Type BIOLOGICAL

Intradermal injection

Interventions

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BCG vial vaccine

Intradermal injection

Intervention Type BIOLOGICAL

BCG ampoule vaccine

Intradermal injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

1 Day

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes