ImmunogenicityPhase 3NCT04071379
Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B
A Phase 3 study testing Recombinant Hepatitis B + DTP-HB-Hib and Hep B + Pentabio (registered) in people with Immunogenicity and Safety, run by PT Bio Farma at 3 sites in Indonesia.
Trial summary
Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B Read more about this study
- Who is it for?
- Ages 0 to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Immunogenicity, Safety
- What is being tested?
- Recombinant Hepatitis B + DTP-HB-Hib and Hep B + Pentabio (registered)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 3 sitesIndonesia
- Study dates
- 13 Oct 2020to 16 Dec 2021
- Phase
- Phase 3
- 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 0 to 3 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy, full term, newborns infants.
- Infant 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 indications of the investigator and with the schedule of the trial.
Who cannot join
- Child concomitantly enrolled or scheduled to be enrolled in another trial.
- Mother with HBsAg positive.
- Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature >37.5C on Day 0).
- Suspected of allergy to any component of the vaccines (e.g. formaldehyde).
- Suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
- Newborn suspected of congenital or acquired immunodeficiency (including HIV infection).
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- 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 BCG and poliomyelitis.
- Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
Trial locations and contacts
3 sites in 1 country.
Indonesia3 sites
Garuda Primary Health Centre
Bandung, West Java
Ibrahim Adjie Primary Health Centre
Bandung, West Java
Puter Primary Health Care
Bandung, West Java
About this study
Official title: Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B at Birth Dose (Using Different Source of Hepatitis B), in Indonesian Infants
Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B
Read the detailed description
Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B at Birth dose (using different source of Hepatitis B), in Indonesian Infants
- Conditions
- Immunogenicity, Safety
- Being tested
- Recombinant Hepatitis B + DTP-HB-Hib, Hep B + Pentabio (registered)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Hepatitis B + DTP-HB-HibBiological
Also called Hep B + DTP-HB-Hib
1 dose of 0.5 ml Recombinant Hepatitis B + 3 dose of 0.5 ml of DTP-HB-Hib
Hep B + Pentabio (registered)Biological
Also called Recombinant Hepatitis B (Bio Farma) + Pentabio (Bio Farma)
1 dose of 0.5 ml Recombinant Hepatitis B (registered) + 3 dose of 0.5 ml of Pentabio (registered)
| Study group | Role | What they receive |
|---|---|---|
| HepB + Penta batch 1 | Experimental | Recombinant Hepatitis B + DTP-HB-Hib batch 1 Receives: Biological: Recombinant Hepatitis B + DTP-HB-Hib |
| Hep B + Pentabio (registered) | Active comparator | Recombinant Hepatitis B + Pentabio (registered) Receives: Biological: Hep B + Pentabio (registered) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) with new Hepatitis B bulk
Percentage of infants with anti-diphtheria titer and anti-tetanus titer > 0.01 IU/ml, anti HbsAg titer > 10 mIU/ml, and anti PRP-T titer > 0.15 ug/ml 28 days after the last injection of DTP/HB/Hib with different source of Hepatitis B bulk vaccine group.
Measured: 28 days after immunization
Secondary outcomes (5)
Describes antibody response to diphtheria toxoid, tetanus toxoid in both group with the evaluation criteria
Serological response to diphtheria toxoid, tetanus toxoid: GMT, percentage of infants with titer > 0.01 IU/ml, > 0.1 IU/ml percentage of infants with increasing antibody titer > 4 times and/or percentage of infants with transition of seronegative to seropositive
Measured: 28 days after immunization
Serological response to the pertussis component (agglutinins)
Serological response to the pertussis component (agglutinins): GMT, percentage of infants with titer > 40, > 80, > 160 and > 320 (1/dil.), percentage of infants with increasing antibody titer > 4 times
Measured: 28 days after immunization
Geometric mean of anti-HbsAg
Geometric mean of anti-HbsAg, percentage of infants with titer > 10mIU/ml, percentage of infants with increasing antibody titer > 4 times and/ or percentage of infants with transition of seronegative to seropositive
Measured: 28 days after immunization
Serological response to Hib/PRP
Serological response to Hib/PRP: GMT, percentage of infants with titer >1 ug /ml ; > 0.15 ug /ml percentage of infants with increasing antibody titer > 4 times and/or percentage of infants with transition of seronegative to seropositive
Measured: 28 days after immunization
Seroconversion
Comparison of GMT, seroprotection, percentage of subjects with increasing antibody titer > 4 times and/ or percentage of subjects with transition of seronegative to seropositive following primary series of investigational product compare to control.
Measured: 28 days after immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start13 Oct 2020
- Primary completion6 Apr 2021
- Study completion16 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunogenicityStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects neonates: Randomized, double blind, 2 arms parallel groups, prospective intervention Study
- 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)
- Responsible party
- Sponsor
- Investigators
- Eddy Fadliyana, Principal investigator, Hasan Sadikin General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071379
- Sponsor's protocol ID
- Penta BS19
- Status last verified
- Jan 2022
- First submitted
- 26 Aug 2019
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B at Birth Dose (Using Different Source of Hepatitis B), in Indonesian Infants
- ClinicalTrials.gov ID
- NCT04071379
- Acronym / sponsor ID
- Penta BS19
- Conditions
- Immunogenicity, Safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 6 Apr 2021 (actual)
- Study completion
- 16 Dec 2021 (actual)
- First posted
- 28 Aug 2019 (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.
Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B
Detailed description
Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B at Birth dose (using different source of Hepatitis B), in Indonesian Infants
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Subjects neonates: Randomized, double blind, 2 arms parallel groups, prospective intervention Study
| Arm | Type | Receives |
|---|---|---|
| HepB + Penta batch 1 | Experimental | Biological: Recombinant Hepatitis B + DTP-HB-HibRecombinant Hepatitis B + DTP-HB-Hib batch 1 |
| Hep B + Pentabio (registered) | Active comparator | Biological: Hep B + Pentabio (registered)Recombinant Hepatitis B + Pentabio (registered) |
Who may qualify
- Ages
- 0 to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy, full term, newborns infants.
- Infant 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 indications of the investigator and with the schedule of the trial.
Key exclusion criteria (9 listed)
- Child concomitantly enrolled or scheduled to be enrolled in another trial.
- Mother with HBsAg positive.
- Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature >37.5C on Day 0).
- Suspected of allergy to any component of the vaccines (e.g. formaldehyde).
- Suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
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 |
|---|---|---|
| Recombinant Hepatitis B + DTP-HB-HibAlso: Hep B + DTP-HB-Hib1 dose of 0.5 ml Recombinant Hepatitis B + 3 dose of 0.5 ml of DTP-HB-Hib | Biological | HepB + Penta batch 1 |
| Hep B + Pentabio (registered)Also: Recombinant Hepatitis B (Bio Farma) + Pentabio (Bio Farma)1 dose of 0.5 ml Recombinant Hepatitis B (registered) + 3 dose of 0.5 ml of Pentabio (registered) | Biological | Hep B + Pentabio (registered) |
Primary outcome
To evaluate protectivity of DTP-HB-Hib Vaccine (Bio Farma) with new Hepatitis B bulk
Time frame: 28 days after immunization
Percentage of infants with anti-diphtheria titer and anti-tetanus titer > 0.01 IU/ml, anti HbsAg titer > 10 mIU/ml, and anti PRP-T titer > 0.15 ug/ml 28 days after the last injection of DTP/HB/Hib with different source of Hepatitis B bulk vaccine group.
5 secondary outcomes
Describes antibody response to diphtheria toxoid, tetanus toxoid in both group with the evaluation criteria
Time frame: 28 days after immunization
Serological response to the pertussis component (agglutinins)
Time frame: 28 days after immunization
Geometric mean of anti-HbsAg
Time frame: 28 days after immunization
Serological response to Hib/PRP
Time frame: 28 days after immunization
Seroconversion
Time frame: 28 days after immunization
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 18 Jan 2022.
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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.
Eddy Fadliyana principal investigator
Hasan Sadikin General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant Hepatitis B + DTP-HB-Hib and Hep B + Pentabio (registered) in people with Immunogenicity and Safety, run by PT Bio Farma at 3 sites 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 9 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 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 protectivity of DTP-HB-Hib Vaccine (Bio Farma) with new Hepatitis B bulk (time frame: 28 days after immunization). 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 18 Jan 2022.