HealthyPhase 2/3NCT02095314
Antibody Persistence, Immune Response and Safety After Doses of Pentabio Vaccine
A Phase 2/3 study testing Pentavalen in people with Healthy, run by PT Bio Farma at 6 sites in Indonesia.
Trial summary
Measure antibody persistence prior to booster administration of Pentabio vaccine. Read more about this study
- Who is it for?
- Ages 18 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pentavalen
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 399 participants
- Where
- 6 sitesIndonesia
- Study dates
- Mar 2014to Dec 2014
- Phase
- Phase 2/3
- 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 18 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children, 18-24 months of age
- Subjects who had completed the primary series of Pentabio vaccine in the previous trial
- Father, mother, or legally acceptable representative have been informed properly regarding the study and signed the informed consent form
- Subject's parents commit to comply with the instruction
Who cannot join
- Subjects concomitantly enrolled or scheduled to be enrolled in another trial
- Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature >=37.5oC on Day 0)
- Known history of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
- Known history of allergy to any component of the vaccines (e.f. formaldehyde)
- Known history of acquired immunodeficiency (including HIV infection)
- Subject who has received a treatment likely to alter immune response in the previous 4 weeks (e.g intravenous immunoglobulin, blood-derived products or long term corticotherapy (>2 weeks)
Show all 9Show fewer
- Subject receives other vaccination within 1 month prior to inclusion
- Any abnormality or chronic disease justified by investigator that might interfere assessment of the trial objectives
- Infant with a known history of diphtheria, tetanus, pertussis, Hepatitis B and Hib infection
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Indonesia6 sites
Garuda Primary Health Center
Bandung, West Java
Ibrahim Adjie Primary Health Center
Bandung, West Java
Puter Primary Health Centre
Bandung, West Java
Jatinegara Primary Health Center
Jakarta, Jakarta Special Capital Region
Mampang Prapatan Primary Health Center
Jakarta, Jakarta Special Capital Region
Tebet Primary Health Center
Jakarta, Jakarta Special Capital Region
About this study
Official title: Antibody Persistence After Primary Doses, Immune Response and Safety After Doses of Pentabio Vaccine in Indonesian Children at 18-24 Months of Age
Measure antibody persistence prior to booster administration of Pentabio vaccine.
Read the detailed description
Number and percentage of children with anti diphtheria, titer and anti tetanus titer >= 0.01 IU/ml, anti HBs >=10mIU/ml, anti Hib >=0.15ug/ml prior to booster administration.
- Conditions
- Healthy
- Being tested
- Pentavalen
- Keywords
- DTP-HB-Hib, Pentavalen, Pentabio, Booster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentavalenBiological
Also called Pentabio vaccine, DPT-HB-Hib
Batch 5010613
| Study group | Role | What they receive |
|---|---|---|
| Pentavalen | Experimental | Pentabio Vaccine One dose corresponds to 0.5ml The vaccine shall be given intramuscularly Receives: Biological: Pentavalen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geomoteric mean titer prior to booster administration of Pentabio vaccine
The number and percentage of children with anti diphtheria titer and anti tetanus titer >=0.01 IU/ml anti HBs >=10 mIU/ml, anti Hib >=0.15 ug/ml prior to booster administration.
Measured: visit 1
Secondary outcomes (4)
Protectivity of Pentabio vaccine 1 month after the booster dose
Serological response to diphtheria, tetanus, pertussis and Hib (Geometric Mean Titer)
Measured: 1 month
Serological response to diphtheria, tetanus, pertussis, hepatitis B and PRP-T before and 1 month after the booster dose
Geometric mean titer to diphtheria, tetanus, pertussis, Hepatitis B and Hib before immunization and 1 month after immunization
Measured: 1 month
Seroconversion and seroprotection before and 1 month after the booster dose
The changes of serological response before and after booster dose
Measured: 1 month
Number of participants with adverse events
Local and systemic reaction within 28 days after immunization.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kusnandi Rusmil, MD, Principal investigator, Department of Child Health, School of Medicine Padjadjaran UniversityHartono Gunardi, MD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095314
- Sponsor's protocol ID
- Booster Penta 0413
- Status last verified
- Dec 2014
- First submitted
- 19 Mar 2014
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Gunardi H, Rusmil K, Fadlyana E, Soedjatmiko, Dhamayanti M, Sekartini R, Tarigan R, Satari HI, Medise BE, Sari RM, Bachtiar NS, Kartasasmita CB, Hadinegoro SRS. DTwP-HB-Hib: antibody persistence after a primary series, immune response and safety after a booster dose in children 18-24 months old. BMC Pediatr. 2018 May 28;18(1):177. doi: 10.1186/s12887-018-1143-6.
PubMed 29804542
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibody Persistence After Primary Doses, Immune Response and Safety After Doses of Pentabio Vaccine in Indonesian Children at 18-24 Months of Age
- ClinicalTrials.gov ID
- NCT02095314
- Acronym / sponsor ID
- Booster Penta 0413
- Conditions
- Healthy
- Keywords
- DTP-HB-Hib, Pentavalen, Pentabio, Booster
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Mar 2014 (estimated)
- 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.
Measure antibody persistence prior to booster administration of Pentabio vaccine.
Detailed description
Number and percentage of children with anti diphtheria, titer and anti tetanus titer >= 0.01 IU/ml, anti HBs >=10mIU/ml, anti Hib >=0.15ug/ml prior to booster administration.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pentavalen | Experimental | Biological: PentavalenPentabio Vaccine One dose corresponds to 0.5ml The vaccine shall be given intramuscularly |
Who may qualify
- Ages
- 18 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children, 18-24 months of age
- Subjects who had completed the primary series of Pentabio vaccine in the previous trial
- Father, mother, or legally acceptable representative have been informed properly regarding the study and signed the informed consent form
- Subject's parents commit to comply with the instruction
Key exclusion criteria (9 listed)
- Subjects concomitantly enrolled or scheduled to be enrolled in another trial
- Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature >=37.5oC on Day 0)
- Known history of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
- Known history of allergy to any component of the vaccines (e.f. formaldehyde)
- Known history of acquired immunodeficiency (including HIV infection)
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 |
|---|---|---|
| PentavalenAlso: Pentabio vaccine, DPT-HB-HibBatch 5010613 | Biological | Pentavalen |
Primary outcome
Geomoteric mean titer prior to booster administration of Pentabio vaccine
Time frame: visit 1
The number and percentage of children with anti diphtheria titer and anti tetanus titer >=0.01 IU/ml anti HBs >=10 mIU/ml, anti Hib >=0.15 ug/ml prior to booster administration.
4 secondary outcomes
Protectivity of Pentabio vaccine 1 month after the booster dose
Time frame: 1 month
Serological response to diphtheria, tetanus, pertussis, hepatitis B and PRP-T before and 1 month after the booster dose
Time frame: 1 month
Seroconversion and seroprotection before and 1 month after the booster dose
Time frame: 1 month
Number of participants with adverse events
Time frame: 1 month
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 Dec 2014.
- Derived from this study: PubMed 29804542Gunardi H, Rusmil K, Fadlyana E, Soedjatmiko, Dhamayanti M, Sekartini R, Tarigan R, Satari HI, Medise BE, Sari RM, Bachtiar NS, Kartasasmita CB, Hadinegoro SRS. DTwP-HB-Hib: antibody persistence after a primary series, immune response and safety after a booster dose in children 18-24 months old. BMC Pediatr. 2018 May 28;18(1):177. doi: 10.1186/s12887-018-1143-6.
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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.
Kusnandi Rusmil, MD principal investigator
Department of Child Health, School of Medicine Padjadjaran University
Hartono Gunardi, MD principal investigator
Universitas Indonesia
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pentavalen in people with Healthy, run by PT Bio Farma at 6 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 4 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 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 combined 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.
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?
Geomoteric mean titer prior to booster administration of Pentabio vaccine (time frame: visit 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02095314, which also lists 1 linked publication.
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 Dec 2014.