search
Back to results

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
Sponsored by
International Centre for Diarrhoeal Disease Research, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Poliomyelitis

Eligibility Criteria

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

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:

  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.

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

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

First Posted
March 19, 2019
Last Updated
April 12, 2022
Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators
World Health Organization
search

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
No
Studies a U.S. FDA-regulated Device Product
No
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
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
Email
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
Email
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
Email
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

Learn more about this trial

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

We'll reach out to this number within 24 hrs