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
About this trial
This is an interventional prevention trial for Poliomyelitis
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
-
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
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
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
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