HealthyPhase 4NCT03310073
Immunogenicity and Safety Profile of Primary Dose of bOPV Bio Farma Given Simultaneously With Pentabio And IPV
A Phase 4 study testing bOPV, Pentabio and IPV in people with Healthy, run by PT Bio Farma at 1 site in Indonesia.
Trial summary
This study is to assess protectivity following four doses of bOPV which given simultaneously with Pentabio® and 1 dose of IPV at the 4th visit Read more about this study
- Who is it for?
- Ages 1 minute to 1 dayHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- bOPV, Pentabio and IPV
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteIndonesia
- Study dates
- Jul 2016to Mar 2017
- Phase
- Phase 4
- 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 minute to 1 day
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy, full term, newborns infants.
- Newborns residing within a relatively short and easily accessible distance (<30 km) from the study clinic(s) and not planning to travel away during the entire study period.
- Infant born after 37 weeks of pregnancy
- Infant weighing 2.5 kg or more at birth (Birth weight > 2.5 kg)
- Healthy newborns, with no history of asphyxia or meconium aspiration.
- 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.
- Mother at least elementary school graduate
Who cannot join
- Child concomitantly enrolled or scheduled to be enrolled in another trial
- Known history of congenital or acquired immunodeficiency (including HIV infection)
- Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥ 37.5°C )
- Newborns requiring hospitalization at birth.
- Infant immunized with non-scheduled bOPV or IPV during trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity and Safety Profile of Primary Dose of Bivalent OPV (bOPV Bio Farma) Given Simultaneously With Pentabio® And Inactivated Poliovirus Vaccine (IPV) at the 4th Visit in Indonesian Infants
This study is to assess protectivity following four doses of bOPV which given simultaneously with Pentabio® and 1 dose of IPV at the 4th visit
Read the detailed description
To describe serological response after four doses of bOPV with 1 dose of IPV. To describe the antibody status to polio 60 days after birth dose of bOPV To assess the safety of bOPV which given simultaneously with Pentabio® and 1 dose 1 dosde of IPV at the 4th visit
- Conditions
- Healthy
- Being tested
- bOPV, Pentabio, IPV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bOPVBiological
Also called bivalent Oral Polio Vaccine
Batch Number: 2042015
PentabioBiological
Also called DTP-HB-Hib Vaccine
Batch number: 5050115 The vaccine shall be given intramuscularly.
IPVBiological
The vaccine shall be given intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| bOPV (bivalent OPV Bio Farma) | Experimental | bOPV one dose corresponds to 2 drops (0.1ml). The vaccine shall be given orally.
The subject received bOPV, Pentabio and IPV according to the study schedule. Receives: Biological: bOPV; Biological: Pentabio; Biological: IPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with anti polio titer ≥ 8 for type 1, 2 and type 3
Evaluate protectivity
Measured: 30 days after the last vaccination
Secondary outcomes (5)
Percentage of infants with increasing antibody titer >= 4 times
Serological response after four doses of bOPV with 1 dose of IPV
Measured: 30 days after the last vaccination
Percentage of infants with transition of seronegative to seropositive
Serological response after four doses of bOPV with 1 dose of IPV
Measured: 30 days after the last vaccination
Geometric Mean Titer (GMT) after four doses of bOPV with 1 dose of IPV
Geometric Mean Titer (GMT) 30 days after the last vaccination
Measured: 30 days after the last vaccination
Number and severity of systemic adverse events (AEs) after each dose of bOPV, which given simultaneously with Pentabio and 1 dose of IPV
Assess the safety of bOPV
Measured: first 30 minutes, 24hour, 48hour, 72hour and 30 days after vaccination.
Number of serious adverse events (SAE) which occured during the study
Assess the safety of bOPV
Measured: 30 days after the last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study startJul 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kusnandi Rusmil, Principal investigator, Hasan Sadikin General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310073
- Sponsor's protocol ID
- bOPV 0416
- Status last verified
- Nov 2017
- First submitted
- 5 Apr 2017
- Last updated
- 8 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety Profile of Primary Dose of Bivalent OPV (bOPV Bio Farma) Given Simultaneously With Pentabio® And Inactivated Poliovirus Vaccine (IPV) at the 4th Visit in Indonesian Infants
- ClinicalTrials.gov ID
- NCT03310073
- Acronym / sponsor ID
- bOPV 0416
- Conditions
- Healthy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 16 Oct 2017 (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.
This study is to assess protectivity following four doses of bOPV which given simultaneously with Pentabio® and 1 dose of IPV at the 4th visit
Detailed description
To describe serological response after four doses of bOPV with 1 dose of IPV. To describe the antibody status to polio 60 days after birth dose of bOPV To assess the safety of bOPV which given simultaneously with Pentabio® and 1 dose 1 dosde of IPV at the 4th visit
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bOPV (bivalent OPV Bio Farma) | Experimental | Biological: bOPV, Biological: Pentabio, Biological: IPVbOPV one dose corresponds to 2 drops (0.1ml). The vaccine shall be given orally. The subject received bOPV, Pentabio and IPV according to the study schedule. |
Who may qualify
- Ages
- 1 minute to 1 day
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Healthy, full term, newborns infants.
- Newborns residing within a relatively short and easily accessible distance (<30 km) from the study clinic(s) and not planning to travel away during the entire study period.
- Infant born after 37 weeks of pregnancy
- Infant weighing 2.5 kg or more at birth (Birth weight > 2.5 kg)
- Healthy newborns, with no history of asphyxia or meconium aspiration.
Key exclusion criteria (5 listed)
- Child concomitantly enrolled or scheduled to be enrolled in another trial
- Known history of congenital or acquired immunodeficiency (including HIV infection)
- Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥ 37.5°C )
- Newborns requiring hospitalization at birth.
- Infant immunized with non-scheduled bOPV or IPV during trial
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 |
|---|---|---|
| bOPVAlso: bivalent Oral Polio VaccineBatch Number: 2042015 | Biological | bOPV (bivalent OPV Bio Farma) |
| PentabioAlso: DTP-HB-Hib VaccineBatch number: 5050115 The vaccine shall be given intramuscularly. | Biological | bOPV (bivalent OPV Bio Farma) |
| IPVThe vaccine shall be given intramuscularly. | Biological | bOPV (bivalent OPV Bio Farma) |
Primary outcome
Number of subjects with anti polio titer ≥ 8 for type 1, 2 and type 3
Time frame: 30 days after the last vaccination
Evaluate protectivity
5 secondary outcomes
Percentage of infants with increasing antibody titer >= 4 times
Time frame: 30 days after the last vaccination
Percentage of infants with transition of seronegative to seropositive
Time frame: 30 days after the last vaccination
Geometric Mean Titer (GMT) after four doses of bOPV with 1 dose of IPV
Time frame: 30 days after the last vaccination
Number and severity of systemic adverse events (AEs) after each dose of bOPV, which given simultaneously with Pentabio and 1 dose of IPV
Time frame: first 30 minutes, 24hour, 48hour, 72hour and 30 days after vaccination.
Number of serious adverse events (SAE) which occured during the study
Time frame: 30 days after the last vaccination
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 8 Nov 2017.
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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 principal investigator
Hasan Sadikin General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bOPV, Pentabio and IPV in people with Healthy, 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 8 inclusion and 5 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 8 Nov 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Number of subjects with anti polio titer ≥ 8 for type 1, 2 and type 3 (time frame: 30 days after the last 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 8 Nov 2017; AzTrials last refreshed its copy on 8 Nov 2026.