PoliomyelitisPhase 4NCT03890497
Assessment of Poliovirus Type 2 Immunogenicity of One and Two Dose Schedule With IPV and fIPV When Administered at 9-13 Months of Age in Bangladesh
A Phase 4 study testing IPV in people with Poliomyelitis, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 2 sites in Bangladesh.
Trial summary
Following a recommendation on October 2017 meeting of the Strategic Advisory Group of Experts (SAGE) on Immunization; low- risk bOPV-using countries may adopt 2 dose fIPV schedule prior to global OPV cessation as it provides better seroconversion than 1 full dose IPV and in the post-cessation era, the 2 fIPV doses… Read more about this study
- Who is it for?
- Ages 9 to 13 monthsHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- IPV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesBangladesh
- Study dates
- 27 Sep 2018to Sep 2022
- 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 9 to 13 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Apparently healthy children with no obvious clinical symptom of illness
- Parents/legal guardians of participants willing to give written informed consent and willing to comply with study protocol.
- Free of obvious health problems (congenital abnormalities, severe malnutrition, acute or chronic diarrhea, bleeding disorder etc) 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,
- A diagnosis or suspicion of bleeding disorder
- Acute or persistent diarrhoea
- History of allergy or systemic hypersensitivity to any of the vaccine components
- Chronic illness at a stage that could interfere with trial conduct or completion.
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- Presence of significant malnutrition
- History of any neurological disorder or history of seizure (febrile or afebrile), or encephalopathy, encephalitis, hypotonic-hyporesponsive episode.
- 09. Febrile illness or acute illness on the day of inclusion
- -
Trial locations and contacts
2 sites in 1 country.
Bangladesh2 sites, 2 recruiting
- Recruiting
Matlab Health Research Centre
Chāndpur
Asma Aziz, MBBS, MPH, +8801719326323 ext. 3812, asma.aziz@icddrb.org
- Recruiting
Mirpur Study clinic
Dhaka
Asma Aziz, MBBS,MPH, +8801719326323 ext. 3812, asma.aziz@icddrb.org
About this study
Official title: Assessment of Poliovirus Type 2 Immunogenicity of One and Two Dose Schedule With IPV and fIPV
Following a recommendation on October 2017 meeting of the Strategic Advisory Group of Experts (SAGE) on Immunization; low- risk bOPV-using countries may adopt 2 dose fIPV schedule prior to global OPV cessation as it provides better seroconversion than 1 full dose IPV and in the post-cessation era, the 2 fIPV doses will provide sufficient (above 90%) seroconversion. Countries, which delayed the introduction of IPV or had a vaccine stock-out, should provide 1 full dose or 2 fIPV doses to all children who were missed as soon as supply becomes available. The IPV supply situation is expected to improve in 2018; all countries are expected to have access to IPV for their routine immunization programmes from the end of the first quarter of 2018.
While immunogenicity after one and two doses of IPV and fIPV has been estimated when administered to younger children ; the immunogenicity of IPV (or fIPV) when administered at 9 months of age or later is not known. We propose to conduct a study to assess the immunogenicity of one and two doses of fIPV and IPV when administered between 9-13 months of age.
- Conditions
- Poliomyelitis
- Being tested
- IPV
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPVBiological
Also called fIPV
The inactivated poliovirus vaccine (IPV) developed by Salk was the first available polio vaccine licensed in 1955 in the United States. The current formulation of IPV got licensed in 1987 and has a higher potency than the original Salk IPV. Almost 100% of children two months of age or older who receive 2-3 doses of intramuscular (IM) IPV achieve high antibody levels against the all three serotypes. IPV (.5mL) can be administered subcutaneously (SC) or IM and fractional (0.1 ml) doses of IPV are generally administered intradermally
| Study group | Role | What they receive |
|---|---|---|
| Full dose of IPV | Active comparator | IPV first dose between 9 -13 months with second dose administered 2 months later. Receives: Biological: IPV |
| Fractional Dose of IPV | Active comparator | fIPV first dose between 9 -13 months with second dose administered 2 months later Receives: Biological: IPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion to PV2 two months after the first fIPV or IPV dose
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start27 Sep 2018
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
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 PoliomyelitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- • To assess the seroconversion to PV2 after one and two doses of fIPV and IPV when first dose is administered to children aged between 9 and 13 months with second dose administered 2 months later.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890497
- Sponsor's protocol ID
- PR-18016
- Status last verified
- Mar 2022
- First submitted
- 19 Mar 2019
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aziz AB, Verma H, Jeyaseelan V, Yunus M, Nowrin S, Moore DD, Mainou BA, Mach O, Sutter RW, Zaman K. One Full or Two Fractional Doses of Inactivated Poliovirus Vaccine for Catch-up Vaccination in Older Infants: A Randomized Clinical Trial in Bangladesh. J Infect Dis. 2022 Oct 17;226(8):1319-1326. doi: 10.1093/infdis/jiac205.
PubMed 35575051
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Poliovirus Type 2 Immunogenicity of One and Two Dose Schedule With IPV and fIPV
- ClinicalTrials.gov ID
- NCT03890497
- Acronym / sponsor ID
- PR-18016
- Conditions
- Poliomyelitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- World Health Organization
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 26 Mar 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.
Following a recommendation on October 2017 meeting of the Strategic Advisory Group of Experts (SAGE) on Immunization; low- risk bOPV-using countries may adopt 2 dose fIPV schedule prior to global OPV cessation as it provides better seroconversion than 1 full dose IPV and in the post-cessation era, the 2 fIPV doses will provide sufficient (above 90%) seroconversion. Countries, which delayed the introduction of IPV or had a vaccine stock-out, should provide 1 full dose or 2 fIPV doses to all children who were missed as soon as supply becomes available. The IPV supply situation is expected to improve in 2018; all countries are expected to have access to IPV for their routine immunization programmes from the end of the first quarter of 2018.
While immunogenicity after one and two doses of IPV and fIPV has been estimated when administered to younger children ; the immunogenicity of IPV (or fIPV) when administered at 9 months of age or later is not known. We propose to conduct a study to assess the immunogenicity of one and two doses of fIPV and IPV when administered between 9-13 months of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- • To assess the seroconversion to PV2 after one and two doses of fIPV and IPV when first dose is administered to children aged between 9 and 13 months with second dose administered 2 months later.
| Arm | Type | Receives |
|---|---|---|
| Full dose of IPV | Active comparator | Biological: IPVIPV first dose between 9 -13 months with second dose administered 2 months later. |
| Fractional Dose of IPV | Active comparator | Biological: IPVfIPV first dose between 9 -13 months with second dose administered 2 months later |
Who may qualify
- Ages
- 9 to 13 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Apparently healthy children with no obvious clinical symptom of illness
- Parents/legal guardians of participants willing to give written informed consent and willing to comply with study protocol.
- Free of obvious health problems (congenital abnormalities, severe malnutrition, acute or chronic diarrhea, bleeding disorder etc) as established by medical history and screening evaluation including clinical examination.
- Resident of study area.
Key exclusion criteria (10 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,
- A diagnosis or suspicion of bleeding disorder
- Acute or persistent diarrhoea
- History of allergy or systemic hypersensitivity to any of the vaccine components
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 |
|---|---|---|
| IPVAlso: fIPVThe inactivated poliovirus vaccine (IPV) developed by Salk was the first available polio vaccine licensed in 1955 in the United States. The current formulation of IPV got licensed in 1987 and has a higher potency than the original Salk IPV. Almost 100% of children two months of age or older who receive 2-3 doses of intramuscular (IM) IPV achieve high antibody levels against the all three serotypes. IPV (.5mL) can be administered subcutaneously (SC) or IM and fractional (0.1 ml) doses of IPV are generally administered intradermally | Biological | Fractional Dose of IPV, Full dose of IPV |
Primary outcome
Seroconversion to PV2 two months after the first fIPV or IPV dose
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Derived from this study: PubMed 35575051Aziz AB, Verma H, Jeyaseelan V, Yunus M, Nowrin S, Moore DD, Mainou BA, Mach O, Sutter RW, Zaman K. One Full or Two Fractional Doses of Inactivated Poliovirus Vaccine for Catch-up Vaccination in Older Infants: A Randomized Clinical Trial in Bangladesh. J Infect Dis. 2022 Oct 17;226(8):1319-1326. doi: 10.1093/infdis/jiac205.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IPV in people with Poliomyelitis, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 2 sites 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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asma Aziz, MBBS, MPH (+8801719326323 ext. 3812, asma.aziz@icddrb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion to PV2 two months after the first fIPV or IPV dose (time frame: 2 months). 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 NCT03890497, 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 13 Apr 2022.