Immune Response to Oral Polio VaccinePhase 3NCT02766816
A Clinical Study Comparing Safety and Immunogenicity of bOPV of Bilthoven Biologicals
A Phase 3 study testing Part 1 study - BBio bOPV, Part 2 study - BBio bOPV Lot 1 and Part 2 study - BBio bOPV Lot 2 in people with Immune Response to Oral Polio Vaccine, run by Bilthoven Biologicals at 1 site in Bangladesh.
Trial summary
Bilthoven Biologicals has developed a new bivalent oral polio vaccine (bOPV) containing World Health Organization (WHO) approved Sabin strains of poliovirus type 1 and type 3. This study will assess non-inferiority of bOPV manufactured by BBio to that of licensed bOPV. Read more about this study
- Who is it for?
- Ages 42 days to 83 monthsHealthy volunteers can take part
- Conditions the study is for
- Immune Response to Oral Polio Vaccine
- What is being tested?
- Part 1 study - BBio bOPV, Part 2 study - BBio bOPV Lot 1 and Part 2 study - BBio bOPV Lot 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,120 participants
- Where
- 1 siteBangladesh
- Study dates
- 8 Jun 2016to 14 Feb 2018
- 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 42 days to 83 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Normal healthy children of both sexes of age 5 to 6 years (60-83 months) at the time of vaccination and who have received at least 3 doses of trivalent oral polio vaccine (tOPV) based upon documentation (Study Part 1).
- Normal healthy infants of both sexes of age 6-8 weeks (42-56 days) at the time of the first vaccination and have not received oral polio vaccine (OPV) previously based upon documentation (Study Part 2).
- Parents/legal guardians of participants willing to give written informed consent and willing to comply with study protocol.
- Free of obvious health problems as established by medical history and screening evaluation including clinical examination.
- Resident of study area.
Who cannot join
- Participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination or planned participation in another clinical trial during the present trial period.
- A diagnosis or suspicion of congenital or acquired immunodeficiency disorder, malignancy, receiving immunosuppressive therapy such as systemic corticosteroids therapy for a period of ≥ 1 week either in the participant or in an immediate family member.
- A diagnosis or suspicion of bleeding disorder that would contraindicate collection of blood by venipuncture.
- Acute or persistent diarrhea (defined as diarrhea that lasts 14 days or longer), infection or illness at the time of enrollment (6-8 weeks of age) that would require participant's admission to a hospital or would contraindicate provision of OPV.
- Acute vomiting and intolerance to liquids within 24 hours before the enrollment visit.
- Infants from multiple births (i.e. twins).
Show all 15Show fewer
- History of allergy or systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the study vaccines or a vaccine containing the same substances.
- Chronic illness at a stage that could interfere with trial conduct or completion.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the study period with the exception of routine Expanded Program on Immunization (EPI) program vaccines including pneumococcal vaccine, and rotavirus vaccine (Polio vaccines are not allowed during the study period).
- Blood or blood-derived products received in the past.
- Any vaccination one week preceding the trial vaccination.
- Presence of significant malnutrition (< -3 standard deviation [SD] weight for length) or acute or chronic, clinically significant pulmonary, endocrine, autoimmune, cardiovascular, metabolic, hepatic or renal functional abnormality, as determined by medical history, and physical examination, which in the opinion of the investigator, might interfere with the study objectives
- History of any neurological disorder or history of seizure (febrile or afebrile), or encephalopathy, encephalitis, hypotonic-hyporesponsive episode.
- Febrile illness or acute illness on the day of inclusion is temporary exclusion criterion.
- Participant with any other condition, which, in the opinion of the investigator would jeopardize the safety or rights of the participant participating in the study or making it unlikely the participant, could complete the protocol.
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
Matlab Hospital Research Centre, International Center for Diarrheal Disease Research, Matlab
Matlab South, Chandpur District, Chittagong, 3640
About this study
Official title: A Phase III, Observer Blind, Active Controlled, Randomized, Clinical Study Comparing Safety and Immunogenicity of BBio Bivalent Oral Polio Vaccine With a Licensed Bivalent Oral Polio Vaccine
Bilthoven Biologicals has developed a new bivalent oral polio vaccine (bOPV) containing World Health Organization (WHO) approved Sabin strains of poliovirus type 1 and type 3. This study will assess non-inferiority of bOPV manufactured by BBio to that of licensed bOPV. This study will also assess lot-to-lot consistency among three lots of BBio bOPV.
Read the detailed description
Bilthoven Biologicals has developed a new bivalent OPV containing WHO approved Sabin strains of poliovirus type 1 and type 3. This phase III study will be conducted in two parts:
Part 1 - 40 children of 60 to 83 months of age will be given single dose of BBio bOPV or licensed bOPV in 1:1 ratio. Primary objective is to assess safety of BBio bOPV.
Part 2 - A total of 1080 infants of 42 to 56 days of age will be randomized to receive three doses of either BBio bOPV from one of the three lots or a licensed bOPV in 1:1:1:1 ratio as primary immunization series at 6, 10 and 14 weeks of age.
Primary objective of this study is to assess non-inferiority of bOPV manufactured by BBio to that of licensed bOPV in terms of seroconversion. This study also will assess lot-to-lot consistency among three lots of BBio bOPV.
- Conditions
- Immune Response to Oral Polio Vaccine
- Being tested
- Part 1 study - BBio bOPV, Part 2 study - BBio bOPV Lot 1, Part 2 study - BBio bOPV Lot 2, Part 2 study - BBio bOPV Lot 3, Part 2 study - Licensed bOPV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part 1 study - BBio bOPVBiological
A single dose of 2 drops (0.1 ml) orally of BBio bOPV to 20 children 60 to 83 months of age.
Part 2 study - BBio bOPV Lot 1Biological
Three doses of 2 drops (0.1 ml) orally of BBio bOPV Lot 1 to 270 infants at 6-8, 10-12 and 14-16 weeks of age.
Part 2 study - BBio bOPV Lot 2Biological
Three doses of 2 drops (0.1 ml) orally of BBio bOPV Lot 2 to 270 infants at 6-8, 10-12 and 14-16 weeks of age.
Part 2 study - BBio bOPV Lot 3Biological
Three doses of 2 drops (0.1 ml) orally of BBio bOPV Lot 3 to 270 infants at 6-8, 10-12 and 14-16 weeks of age.
Part 2 study - Licensed bOPVBiological
Three doses of 2 drops (0.1 ml) orally of a licensed bOPV to 270 infants at 6-8, 10-12 and 14-16 weeks of age.
Part 1 study - Licensed bOPVBiological
A single dose of 2 drops (0.1 ml) orally of a licensed bOPV to 20 children 60 to 83 months of age.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Study - BBio bOPV | Experimental | Not described Receives: Biological: Part 1 study - BBio bOPV |
| Part 1 Study - Licensed bOPV | Active comparator | Not described Receives: Biological: Part 1 study - Licensed bOPV |
| Part 2 Study - BBio bOPV Lot 1 | Experimental | Not described Receives: Biological: Part 2 study - BBio bOPV Lot 1 |
| Part 2 Study - BBio bOPV Lot 2 | Experimental | Not described Receives: Biological: Part 2 study - BBio bOPV Lot 2 |
| Part 2 Study - BBio bOPV Lot 3 | Experimental | Not described Receives: Biological: Part 2 study - BBio bOPV Lot 3 |
| Part 2 Study - Licensed bOPV | Active comparator | Not described Receives: Biological: Part 2 study - Licensed bOPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 study: Frequency of adverse events (AEs)
Safety of single dose of BBio bOPV will be assessed at 4 days after vaccination.
Measured: 4 Days
Part 2 study: Percentage of seroconversion to poliovirus type 1 and type 3
Percentage of seroconversion to poliovirus type 1 and type 3 one month after administration of third dose of the BBio bOPV to that of control group bOPV to assess non-inferiority of BBio bOPV to that of a licensed bOPV.
Measured: one month after dose 3
Part 1 study: Frequency of AEs and serious AEs (SAEs)
Safety of single dose of BBio bOPV will be assessed at 28 days after vaccination.
Measured: 28 days
Secondary outcomes (7)
Part 1 study: Percentage of seroprotection to poliovirus type 1 and type 3
Percentage of seroprotection to poliovirus type 1 and type 3 one month after administration of single dose of the BBio bOPV to that of control group.
Measured: one month
Part 1 study: Geometric mean titers (GMTs) of poliovirus neutralizing antibody (PVNA) to poliovirus type 1 and type 3
GMTs of PVNA to poliovirus type 1 and type 3 at one month after administration of single dose of the BBio bOPV.
Measured: one month
Part 2 study: GMTs of serum PVNA for the three lots of BBio bOPV
Serum PVNA concentrations expressed as GMTs for the BBio bOPV to assess equivalence in manufacturing consistency among three current Good Manufacturing Practices (cGMP) lots of the BBio bOPV.
Measured: one month after dose 3
Part 2 study: GMTs of PVNA to poliovirus type 1 and type 3
Comparison of GMTs of PVNA to poliovirus type 1 and type 3 at one month after administration of third dose of the BBio bOPV to that of control group bOPV.
Measured: one month after dose 3
Part 2 study: Percentage of seroprotection to poliovirus type 1 and type 3
Percentage of seroprotection to poliovirus type 1 and type 3 one month after administration of third dose of the BBio bOPV to that of control group bOPV.
Measured: one month after dose 3
Part 2 study: Frequency of adverse events within 4 days following the administration of each dose of vaccine
Frequency of adverse events within 4 days following the administration of each dose of vaccine
Measured: 4 days after each dose of vaccine
Part 2 study: Frequency of adverse events and serious adverse events
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study start8 Jun 2016
- Primary completion14 Feb 2018
- Study completion14 Feb 2018
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 Immune Response to Oral Polio VaccineStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bilthoven Biologicals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Serum Institute of India Pvt. Ltd.
- Responsible party
- Sponsor
- Investigators
- K Zaman, MBBS, MPH, Principal investigator, International Center for Diarrheal Disease Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766816
- Sponsor's protocol ID
- OPV-03/PR-15106
- Other IDs
- PR-15106
- Status last verified
- Jul 2019
- First submitted
- 6 May 2016
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Zaman K, Kingma R, Yunus M, van Straaten I, Mekkes D, Bouwstra X, Gunale B, Kulkarni PS. Safety, immunogenicity and lot-to-lot consistency of a new Bivalent Oral Polio Vaccine (bOPV) in healthy Infants: Results of a Phase III, observer blind, randomized, controlled clinical study. Vaccine. 2019 Jul 18;37(31):4275-4280. doi: 10.1016/j.vaccine.2019.06.048. Epub 2019 Jun 22.
PubMed 31235374
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Observer Blind, Active Controlled, Randomized, Clinical Study Comparing Safety and Immunogenicity of BBio Bivalent Oral Polio Vaccine With a Licensed Bivalent Oral Polio Vaccine
- ClinicalTrials.gov ID
- NCT02766816
- Acronym / sponsor ID
- OPV-03/PR-15106
- Conditions
- Immune Response to Oral Polio Vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,120 participants (actual)
- Lead sponsor
- Bilthoven BiologicalsIndustry (pharma, biotech, devices)
- Collaborators
- Serum Institute of India Pvt. Ltd.
- Study start
- 8 Jun 2016 (actual)
- Primary completion
- 14 Feb 2018 (actual)
- Study completion
- 14 Feb 2018 (actual)
- First posted
- 10 May 2016 (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.
Bilthoven Biologicals has developed a new bivalent oral polio vaccine (bOPV) containing World Health Organization (WHO) approved Sabin strains of poliovirus type 1 and type 3. This study will assess non-inferiority of bOPV manufactured by BBio to that of licensed bOPV. This study will also assess lot-to-lot consistency among three lots of BBio bOPV.
Detailed description
Bilthoven Biologicals has developed a new bivalent OPV containing WHO approved Sabin strains of poliovirus type 1 and type 3. This phase III study will be conducted in two parts:
Part 1 - 40 children of 60 to 83 months of age will be given single dose of BBio bOPV or licensed bOPV in 1:1 ratio. Primary objective is to assess safety of BBio bOPV.
Part 2 - A total of 1080 infants of 42 to 56 days of age will be randomized to receive three doses of either BBio bOPV from one of the three lots or a licensed bOPV in 1:1:1:1 ratio as primary immunization series at 6, 10 and 14 weeks of age.
Primary objective of this study is to assess non-inferiority of bOPV manufactured by BBio to that of licensed bOPV in terms of seroconversion. This study also will assess lot-to-lot consistency among three lots of BBio bOPV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1 Study - BBio bOPV | Experimental | Biological: Part 1 study - BBio bOPV |
| Part 1 Study - Licensed bOPV | Active comparator | Biological: Part 1 study - Licensed bOPV |
| Part 2 Study - BBio bOPV Lot 1 | Experimental | Biological: Part 2 study - BBio bOPV Lot 1 |
| Part 2 Study - BBio bOPV Lot 2 | Experimental | Biological: Part 2 study - BBio bOPV Lot 2 |
| Part 2 Study - BBio bOPV Lot 3 | Experimental | Biological: Part 2 study - BBio bOPV Lot 3 |
| Part 2 Study - Licensed bOPV | Active comparator | Biological: Part 2 study - Licensed bOPV |
Who may qualify
- Ages
- 42 days to 83 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Normal healthy children of both sexes of age 5 to 6 years (60-83 months) at the time of vaccination and who have received at least 3 doses of trivalent oral polio vaccine (tOPV) based upon documentation (Study Part 1).
- Normal healthy infants of both sexes of age 6-8 weeks (42-56 days) at the time of the first vaccination and have not received oral polio vaccine (OPV) previously based upon documentation (Study Part 2).
- Parents/legal guardians of participants willing to give written informed consent and willing to comply with study protocol.
- Free of obvious health problems as established by medical history and screening evaluation including clinical examination.
- Resident of study area.
Key exclusion criteria (15 listed)
- Participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination or planned participation in another clinical trial during the present trial period.
- A diagnosis or suspicion of congenital or acquired immunodeficiency disorder, malignancy, receiving immunosuppressive therapy such as systemic corticosteroids therapy for a period of ≥ 1 week either in the participant or in an immediate family member.
- A diagnosis or suspicion of bleeding disorder that would contraindicate collection of blood by venipuncture.
- Acute or persistent diarrhea (defined as diarrhea that lasts 14 days or longer), infection or illness at the time of enrollment (6-8 weeks of age) that would require participant's admission to a hospital or would contraindicate provision of OPV.
- Acute vomiting and intolerance to liquids within 24 hours before the enrollment visit.
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 |
|---|---|---|
| Part 1 study - BBio bOPVA single dose of 2 drops (0.1 ml) orally of BBio bOPV to 20 children 60 to 83 months of age. | Biological | Part 1 Study - BBio bOPV |
| Part 2 study - BBio bOPV Lot 1Three doses of 2 drops (0.1 ml) orally of BBio bOPV Lot 1 to 270 infants at 6-8, 10-12 and 14-16 weeks of age. | Biological | Part 2 Study - BBio bOPV Lot 1 |
| Part 2 study - BBio bOPV Lot 2Three doses of 2 drops (0.1 ml) orally of BBio bOPV Lot 2 to 270 infants at 6-8, 10-12 and 14-16 weeks of age. | Biological | Part 2 Study - BBio bOPV Lot 2 |
| Part 2 study - BBio bOPV Lot 3Three doses of 2 drops (0.1 ml) orally of BBio bOPV Lot 3 to 270 infants at 6-8, 10-12 and 14-16 weeks of age. | Biological | Part 2 Study - BBio bOPV Lot 3 |
| Part 2 study - Licensed bOPVThree doses of 2 drops (0.1 ml) orally of a licensed bOPV to 270 infants at 6-8, 10-12 and 14-16 weeks of age. | Biological | Part 2 Study - Licensed bOPV |
| Part 1 study - Licensed bOPVA single dose of 2 drops (0.1 ml) orally of a licensed bOPV to 20 children 60 to 83 months of age. | Biological | Part 1 Study - Licensed bOPV |
Primary outcome
Part 1 study: Frequency of adverse events (AEs)
Time frame: 4 Days
Safety of single dose of BBio bOPV will be assessed at 4 days after vaccination.
Part 2 study: Percentage of seroconversion to poliovirus type 1 and type 3
Time frame: one month after dose 3
Percentage of seroconversion to poliovirus type 1 and type 3 one month after administration of third dose of the BBio bOPV to that of control group bOPV to assess non-inferiority of BBio bOPV to that of a licensed bOPV.
Part 1 study: Frequency of AEs and serious AEs (SAEs)
Time frame: 28 days
Safety of single dose of BBio bOPV will be assessed at 28 days after vaccination.
7 secondary outcomes
Part 1 study: Percentage of seroprotection to poliovirus type 1 and type 3
Time frame: one month
Part 1 study: Geometric mean titers (GMTs) of poliovirus neutralizing antibody (PVNA) to poliovirus type 1 and type 3
Time frame: one month
Part 2 study: GMTs of serum PVNA for the three lots of BBio bOPV
Time frame: one month after dose 3
Part 2 study: GMTs of PVNA to poliovirus type 1 and type 3
Time frame: one month after dose 3
Part 2 study: Percentage of seroprotection to poliovirus type 1 and type 3
Time frame: one month after dose 3
Part 2 study: Frequency of adverse events within 4 days following the administration of each dose of vaccine
Time frame: 4 days after each dose of vaccine
Part 2 study: Frequency of adverse events and serious adverse events
Time frame: 84 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 29 Jul 2019.
- Background: PubMed 31235374Zaman K, Kingma R, Yunus M, van Straaten I, Mekkes D, Bouwstra X, Gunale B, Kulkarni PS. Safety, immunogenicity and lot-to-lot consistency of a new Bivalent Oral Polio Vaccine (bOPV) in healthy Infants: Results of a Phase III, observer blind, randomized, controlled clinical study. Vaccine. 2019 Jul 18;37(31):4275-4280. doi: 10.1016/j.vaccine.2019.06.048. Epub 2019 Jun 22.
- Individual participant dataSharing planned: No
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.
K Zaman, MBBS, MPH principal investigator
International Center for Diarrheal Disease Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Part 1 study - BBio bOPV, Part 2 study - BBio bOPV Lot 1 and Part 2 study - BBio bOPV Lot 2 in people with Immune Response to Oral Polio Vaccine, run by Bilthoven Biologicals at 1 site in Bangladesh.
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 15 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 29 Jul 2019. 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 Bangladesh. 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?
Part 1 study: Frequency of adverse events (AEs) (time frame: 4 Days). The study lists 3 primary outcomes in all. 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 NCT02766816, 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 29 Jul 2019.