CClinicalTrials.gg
Sign In
CompletedNCT05124340Updated Sep 19, 2022

Safety and Tuberculin Conversion Following BCG Vaccination

A Phase 2 interventional study of BCG vial vaccine and BCG ampoule vaccine in BCG Vaccination Reaction, sponsored by PT Bio Farma. Completed at 1 site in Indonesia. Open to participants aged 1 Day to 1 Month, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-19.

Sponsored by PT Bio Farma · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
1 Day to 1 Month
Sex
All
01

Study 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).

Read the detailed 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.

02

Conditions studied

  • BCG Vaccination Reaction

Keywords

  • BCG Vaccine
  • Safety of BCG Vaccine
  • Tuberculin Conversion
03

In context

Lead sponsor

PT Bio Farma is the lead sponsor of 44 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 1 Month
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
220 participants (actual)

Study arms

  • Experimental
    Vaccine

    1 dose of BCG vial vaccine injected in right deltoid armintradermally

    Biological: BCG vial vaccine

  • Active comparator
    Active Comparator

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

    Biological: BCG ampoule vaccine

Interventions

  • BiologicalBCG vial vaccine

    Intradermal injection

  • BiologicalBCG ampoule vaccine

    Intradermal injection

06

What researchers measure

Primary outcomes

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

    Number and percentage of subject experience local reactions and systemic events occurring within 30 minutes after vaccination.

    Time frame: 30 minutes after vaccination

Secondary outcomes

  1. To assess the local and systemic reactions within 30 minutes, 24 hours, 48 hours, 72 hours, 7 days and 30 days after vaccination.

    Number and percentage of subject experience ;ocal reactions and systemic events occurring within 24 hours, 48 hours, 72 hours, 7 days and 30 days after vaccination will be assessed per group with 95% CI.

    Time frame: 30 days after vaccination

  2. To assess local reactions at 60 days and 90 days after vaccination in each group.

    Number and percentage of subject experience local reactions at 60 days and 90 days after vaccination will be assessed per group with 95% CI.

    Time frame: 90 days after vaccination

  3. To assess serious adverse events within 30 days after vaccinantion in each group.

    Number and percentage of subject experience Serious Adverse Events within 30 days after vaccination will be described.

    Time frame: 30 days

  4. To assess the tuberculin conversion in each group.

    Number and percentage of subject who have tuberculin conversion

    Time frame: 2 days

07

Study locations

1 site
  • Puskesmas Cerme
    Gresik, Jawa Timur, Indonesia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05124340
Lead sponsor
PT Bio Farma
Collaborators
Dr. Soetomo General Hospital
Responsible party
Sponsor
First posted
Nov 17, 2021
Start date
Dec 1, 2021
Primary completion
May 31, 2022
Completion
Jul 30, 2022
Last update
Sep 19, 2022

Study contacts

Dominicus Husada, MD
principal investigator · RS DR Soetomo Surabaya

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

PT Bio Farma

Start the discussion