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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

Primary Purpose

Poliomyelitis

Status

Recruiting

Phase

Phase 4

Locations

Bangladesh

Study Type

Interventional

Intervention

IPV

About this trial

This is an interventional prevention trial for Poliomyelitis

Eligibility Criteria

9 Months - 13 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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

Sites / Locations

Matlab Health Research CentreRecruiting
Mirpur Study clinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Full dose of IPV

Fractional Dose of IPV

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03890497

First Posted

March 19, 2019

Last Updated

April 12, 2022

Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh

Collaborators

World Health Organization

1. Study Identification

Unique Protocol Identification Number

NCT03890497

Brief Title

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

Official Title

Assessment of Poliovirus Type 2 Immunogenicity of One and Two Dose Schedule With IPV and fIPV

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 27, 2018 (Actual)

Primary Completion Date

September 2022 (Anticipated)

Study Completion Date

September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh

Collaborators

World Health Organization

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Poliomyelitis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Full dose of IPV

Arm Type

Active Comparator

Arm Description

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

Arm Title

Fractional Dose of IPV

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

IPV

Other Intervention Name(s)

fIPV

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

9 Months

Maximum Age & Unit of Time

13 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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 -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Asma Aziz, MBBS, MPH

Phone

+8801719326323

Ext

3812

asma.aziz@icddrb.org

Facility Information:

Facility Name

Matlab Health Research Centre

City

Chandpur

Country

Bangladesh

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Asma Aziz, MBBS, MPH

Phone

+8801719326323

Ext

3812

asma.aziz@icddrb.org

Facility Name

Mirpur Study clinic

City

Dhaka

Country

Bangladesh

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Asma Aziz, MBBS,MPH

Phone

+8801719326323

Ext

3812

asma.aziz@icddrb.org

12. IPD Sharing Statement

Citations:

PubMed Identifier

35575051

Citation

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.

Results Reference

derived

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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

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