BCG Vaccination ReactionPhase 2NCT05124340
Safety and Tuberculin Conversion Following BCG Vaccination
A Phase 2 study testing BCG vial vaccine and BCG ampoule vaccine in people with BCG Vaccination Reaction, run by PT Bio Farma at 1 site in Indonesia.
Trial 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 more about this study
- Who is it for?
- Ages 1 day to 1 monthHealthy volunteers can take part
- Conditions the study is for
- BCG Vaccination Reaction
- What is being tested?
- BCG vial vaccine and BCG ampoule vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Dec 2021to 30 Jul 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Tuberculin Conversion Following BCG Vaccine Vial (Bio Farma) Compared to Registered BCG Vaccine (Bio Farma) in Indonesian Infants
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.
- Conditions
- BCG Vaccination Reaction
- Being tested
- BCG vial vaccine, BCG ampoule vaccine
- Keywords
- BCG Vaccine, Safety of BCG Vaccine, Tuberculin Conversion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCG vial vaccineBiological
Intradermal injection
BCG ampoule vaccineBiological
Intradermal injection
| Study group | Role | What they receive |
|---|---|---|
| Vaccine | Experimental | 1 dose of BCG vial vaccine injected in right deltoid armintradermally Receives: Biological: BCG vial vaccine |
| Active Comparator | Active comparator | 1 dose of BCG ampoule vaccine injected in right deltoid arm intradermally Receives: Biological: BCG ampoule vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 30 days after vaccination
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.
Measured: 90 days after vaccination
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.
Measured: 30 days
To assess the tuberculin conversion in each group.
Number and percentage of subject who have tuberculin conversion
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start1 Dec 2021
- Primary completion31 May 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BCG Vaccination ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dr. Soetomo General Hospital
- Responsible party
- Sponsor
- Investigators
- Dominicus Husada, MD, Principal investigator, RS DR Soetomo Surabaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124340
- Sponsor's protocol ID
- BS BCG 0221
- Status last verified
- Sep 2022
- First submitted
- 26 Oct 2021
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tuberculin Conversion Following BCG Vaccine Vial (Bio Farma) Compared to Registered BCG Vaccine (Bio Farma) in Indonesian Infants
- ClinicalTrials.gov ID
- NCT05124340
- Acronym / sponsor ID
- BS BCG 0221
- Conditions
- BCG Vaccination Reaction
- Keywords
- BCG Vaccine, Safety of BCG Vaccine, Tuberculin Conversion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Collaborators
- Dr. Soetomo General Hospital
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine | Experimental | Biological: BCG vial vaccine1 dose of BCG vial vaccine injected in right deltoid armintradermally |
| Active Comparator | Active comparator | Biological: BCG ampoule vaccine1 dose of BCG ampoule vaccine injected in right deltoid arm intradermally |
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCG vial vaccineIntradermal injection | Biological | Vaccine |
| BCG ampoule vaccineIntradermal injection | Biological | Active Comparator |
Primary outcome
To evaluate the safety of BCG Vaccine Vial (Bio Farma)
Time frame: 30 minutes after vaccination
Number and percentage of subject experience local reactions and systemic events occurring within 30 minutes after vaccination.
4 secondary outcomes
To assess the local and systemic reactions within 30 minutes, 24 hours, 48 hours, 72 hours, 7 days and 30 days after vaccination.
Time frame: 30 days after vaccination
To assess local reactions at 60 days and 90 days after vaccination in each group.
Time frame: 90 days after vaccination
To assess serious adverse events within 30 days after vaccinantion in each group.
Time frame: 30 days
To assess the tuberculin conversion in each group.
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominicus Husada, MD principal investigator
RS DR Soetomo Surabaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BCG vial vaccine and BCG ampoule vaccine in people with BCG Vaccination Reaction, run by PT Bio Farma at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety of BCG Vaccine Vial (Bio Farma) (time frame: 30 minutes after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.