HealthyPhase 2NCT02093273
Evaluation on Immunogenicity and Safety Profile of Trivalent OPV (tOPV Bio Farma)
A Phase 2 study testing tOPV pilot batch and tOPV commercial batch in people with Healthy, run by PT Bio Farma at 4 sites in Indonesia.
Trial summary
The objective of this study is to compare the antibody response 30 days after two doses of t OPV 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?
- tOPV pilot batch and tOPV commercial batch
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 4 sitesIndonesia
- Study dates
- May 2013to Feb 2014
- 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 minute to 1 day
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy, full term, newborns infants
- newborn residing within a relatively short and easily accessible distance A(<30km) 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 2.5kg or more at birth (birth weight >= 2.5kg)
- 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 >=37.5oC
- Newborns requiring hospitalization at birth
- Infant immunized with non-scheduled OPV or IPV during trial
Trial locations and contacts
4 sites in 1 country.
Indonesia4 sites
Garuda Primary Health Center
Bandung, West Java
Ibrahim Adjie Primary Health Centre
Bandung, West Java
Padasuka Primary Health Centre
Bandung, West Java
Puter Primary Health Centre
Bandung, West Java
About this study
Official title: Phase II, Randomized, Double Blind, Prospective Intervention Study to Evaluate the Immunogenicity and Safety Profile of tOPV (Bio Farma) With Different Batch Numbers in Indonesian Infants
The objective of this study is to compare the antibody response 30 days after two doses of t OPV
Read the detailed description
The trial design is phase II, randomized, double blind, prospective intervention study. The subject study are 240 healthy, full term, newborn infants.
- Conditions
- Healthy
- Being tested
- tOPV pilot batch, tOPV commercial batch
- Keywords
- tOPV, Antibody response, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tOPV pilot batchBiological
Also called tOPV (Bio Farma)
the tOPV vaccine is given orally
tOPV commercial batchBiological
Also called tOPV (Bio Farma)
tOPV vaccine is given orally
| Study group | Role | What they receive |
|---|---|---|
| tOPV commercial batch (Bio Farma) | Active comparator | tOPV (Bio Farma) one dose correspond to 2 drops (0.1ml) Receives: Biological: tOPV commercial batch |
| tOPV pilot batch | Experimental | tOPV (Bio Farma), one dose correspond to 2 drops (0.1ml) Receives: Biological: tOPV pilot batch |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the antibody response 30 days after two doses of tOPV
antibody titer to Polio
Measured: 30 days
Secondary outcomes (1)
To asses and compare the safety of tOPV
Data collection of local and systemic reaction after immunization
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startMay 2013
- Primary completionJan 2014
- Study completionFeb 2014
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eddy Fadlyana, MD, Principal investigator, Department of Child Health of Medicine Padjadjaran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093273
- Sponsor's protocol ID
- OPV 0213
- Status last verified
- Mar 2014
- First submitted
- 19 Mar 2014
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Randomized, Double Blind, Prospective Intervention Study to Evaluate the Immunogenicity and Safety Profile of tOPV (Bio Farma) With Different Batch Numbers in Indonesian Infants
- ClinicalTrials.gov ID
- NCT02093273
- Acronym / sponsor ID
- OPV 0213
- Conditions
- Healthy
- Keywords
- tOPV, Antibody response, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 20 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.
The objective of this study is to compare the antibody response 30 days after two doses of t OPV
Detailed description
The trial design is phase II, randomized, double blind, prospective intervention study. The subject study are 240 healthy, full term, newborn infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tOPV commercial batch (Bio Farma) | Active comparator | Biological: tOPV commercial batchtOPV (Bio Farma) one dose correspond to 2 drops (0.1ml) |
| tOPV pilot batch | Experimental | Biological: tOPV pilot batchtOPV (Bio Farma), one dose correspond to 2 drops (0.1ml) |
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
- newborn residing within a relatively short and easily accessible distance A(<30km) 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 2.5kg or more at birth (birth weight >= 2.5kg)
- 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 >=37.5oC
- Newborns requiring hospitalization at birth
- Infant immunized with non-scheduled OPV 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 |
|---|---|---|
| tOPV pilot batchAlso: tOPV (Bio Farma)the tOPV vaccine is given orally | Biological | tOPV pilot batch |
| tOPV commercial batchAlso: tOPV (Bio Farma)tOPV vaccine is given orally | Biological | tOPV commercial batch (Bio Farma) |
Primary outcome
To compare the antibody response 30 days after two doses of tOPV
Time frame: 30 days
antibody titer to Polio
1 secondary outcome
To asses and compare the safety of tOPV
Time frame: 30 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 20 Mar 2014.
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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 Fadlyana, MD principal investigator
Department of Child Health of Medicine Padjadjaran University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tOPV pilot batch and tOPV commercial batch in people with Healthy, run by PT Bio Farma at 4 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 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 20 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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 compare the antibody response 30 days after two doses of tOPV (time frame: 30 days). 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 20 Mar 2014.