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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 November 2016 |
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Main ID: |
NCT02477046 |
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Date of registration:
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18/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Assessment of Community Transmission of Sabin Type 2 Virus in Bangladesh
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Scientific title:
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Assessment of Community Transmission of Sabin Type 2 Virus in Bangladesh |
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Date of first enrolment:
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April 2015 |
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Target sample size:
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810 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02477046 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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Phase 3
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Countries of recruitment
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Bangladesh
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Contacts
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Name:
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Mami Taniuchi, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Virginia |
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Name:
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K Zaman, MBBS, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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International Centre for Diarrhoeal Disease Research, Bangladesh |
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Name:
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William A Petri, Jr., MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Virginia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- A male or female infant at least 6 weeks of age (42-48 days) at the time of
enrollment
- For the Special Immunization Activity (SIA) only, being age 5 years or younger at the
time of the SIA
- An infant whose parent or guardian's primary residence, at the time of first Expanded
Program on Immunization (EPI) vaccinations, is a village selected to receive polio
vaccine.
- Written informed consent obtained from the parent or guardian of the participant,
prior to the participants's first study vaccination
Exclusion Criteria:
- History of prior polio vaccination (in the 810 infants enrolled at 6 weeks of age
only)
- Hypersensitivity to the active substance or any component in the vaccine
- Subjects with uncorrected congenital malformation
- Infants with known or suspected immunodeficiency
Age minimum:
42 Days
Age maximum:
48 Days
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Vaccine Virus Shedding
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Intervention(s)
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Biological: tOPV
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Biological: IPV
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Biological: bOPV
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Primary Outcome(s)
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fecal shedding of type 2 Sabin virus by quantitative reverse transcription polymerase chain reaction (RT-qPCR) in 60% of infants that did not receive the mOPV2 challenge
[Time Frame: 10 weeks following mOPV2 challenge at month 9 of the study]
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Secondary Outcome(s)
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fecal shedding of type 2 Sabin virus by RT-qPCR in 40% of infants that received the mOPV2 challenge
[Time Frame: 10 weeks following mOPV2 challenge at month 9 of the study]
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Secondary ID(s)
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00000447
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PR-15004
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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