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
1 other identifier
interventional
300
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2018
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 27, 2018
CompletedFirst Submitted
Initial submission to the registry
March 19, 2019
CompletedFirst Posted
Study publicly available on registry
March 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedApril 13, 2022
March 1, 2022
3.9 years
March 19, 2019
April 12, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Seroconversion to PV2 two months after the first fIPV or IPV dose
2 months
Study Arms (2)
Full dose of IPV
ACTIVE COMPARATORIPV first dose between 9 -13 months with second dose administered 2 months later.
Fractional Dose of IPV
ACTIVE COMPARATORfIPV first dose between 9 -13 months with second dose administered 2 months later
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Matlab Health Research Centre
Chāndpur, Bangladesh
Mirpur Study clinic
Dhaka, Bangladesh
Related Publications (1)
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.
PMID: 35575051DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2019
First Posted
March 26, 2019
Study Start
September 27, 2018
Primary Completion
September 1, 2022
Study Completion
September 1, 2022
Last Updated
April 13, 2022
Record last verified: 2022-03