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Status unknownNCT03890497Updated Apr 13, 2022

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 interventional study of IPV in Poliomyelitis, sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh. Status unknown at 2 sites in Bangladesh. Open to participants aged 9 Months to 13 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-13.

Sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Sep 2018, registered Mar 2019).
Phase
Phase 4
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
9 Months to 13 Months
Sex
All
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Study 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 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.

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Conditions studied

  • Poliomyelitis

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In context

Poliomyelitis

222 studies on the registry are indexed under Poliomyelitis; 11 are open to participants now.

This study's planned enrollment of 300 is below the median of 456 across 199 interventional studies indexed under Poliomyelitis.

Browse Poliomyelitis studies →

Lead sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh is the lead sponsor of 197 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
9 Months to 13 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Apparently healthy children with no obvious clinical symptom of illness
  2. Parents/legal guardians of participants willing to give written informed consent and willing to comply with study protocol.
  3. 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.
  4. Resident of study area.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. A diagnosis or suspicion of congenital or acquired immunodeficiency disorder, malignancy,
  3. A diagnosis or suspicion of bleeding disorder
  4. Acute or persistent diarrhoea
  5. History of allergy or systemic hypersensitivity to any of the vaccine components
  6. Chronic illness at a stage that could interfere with trial conduct or completion.
  7. Presence of significant malnutrition
  8. History of any neurological disorder or history of seizure (febrile or afebrile), or encephalopathy, encephalitis, hypotonic-hyporesponsive episode.
  1. Febrile illness or acute illness on the day of inclusion

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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Active comparator
    Full dose of IPV

    IPV first dose between 9 -13 months with second dose administered 2 months later.

    Biological: IPV

  • Active comparator
    Fractional Dose of IPV

    fIPV first dose between 9 -13 months with second dose administered 2 months later

    Biological: IPV

Interventions

  • BiologicalIPV

    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

    Also known as: fIPV

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What researchers measure

Primary outcomes

  1. Seroconversion to PV2 two months after the first fIPV or IPV dose

    Time frame: 2 months

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Study locations

2 of 2 sites recruiting
  • Matlab Health Research Centre
    Chandpur, Bangladesh
    Recruiting
  • Mirpur Study clinic
    Dhaka, Bangladesh
    Recruiting
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03890497
Lead sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators
World Health Organization
Responsible party
Sponsor
First posted
Mar 26, 2019
Start date
Sep 27, 2018
Primary completion
Sep 2022 (estimated)
Completion
Sep 2022 (estimated)
Last update
Apr 13, 2022

Study contacts

Asma Aziz, MBBS, MPH
Contact
asma.aziz@icddrb.org
+8801719326323 ext. 3812

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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