NCT05124340

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 17, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

6 months

First QC Date

October 26, 2021

Last Update Submit

September 15, 2022

Conditions

BCG Vaccination Reaction

Keywords

BCG VaccineSafety of BCG VaccineTuberculin Conversion

Outcome Measures

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.

    30 minutes after vaccination

Secondary Outcomes (4)

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

    30 days after vaccination

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

    90 days after vaccination

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

    30 days

  • To assess the tuberculin conversion in each group.

    2 days

Study Arms (2)

Vaccine

EXPERIMENTAL

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

BCG vial vaccineBIOLOGICAL

Intradermal injection

Vaccine
BCG ampoule vaccineBIOLOGICAL

Intradermal injection

Active Comparator

Eligibility Criteria

Age1 Day - 1 Month
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Mothers with HbsAg and HIV positive (by rapid test)
  • Parents planning to move from the study area before the end of study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Puskesmas Cerme

Gresik, East Java, Indonesia

Location

Study Officials

  • Dominicus Husada, MD

    RS DR Soetomo Surabaya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Observer Blind : Investigational Product and Active Comparator are masking. Lot number is masking
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2021

First Posted

November 17, 2021

Study Start

December 1, 2021

Primary Completion

May 31, 2022

Study Completion

July 30, 2022

Last Updated

September 19, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)