Actively Recruiting
Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh
Led by PATH · Updated on 2026-01-09
2232
Participants Needed
1
Research Sites
163 weeks
Total Duration
On this page
Sponsors
P
PATH
Lead Sponsor
B
Bill and Melinda Gates Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this clinical trial is to assess the safety and tolerability (primary objective), immunogenicity (primary and secondary objectives), fecal shedding of vaccine viruses (secondary objective) and the potential for neurovirulence of shed virus (secondary objective) of a novel oral polio type 1 vaccine, nOPV1, as compared to Sabin monovalent type 1 vaccine controls (mOPV1), in healthy young children (192 subjects), infants (720 subjects), and neonates (1320 subjects).
CONDITIONS
Official Title
Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy with no clinically significant medical condition or congenital anomaly
- Parent or guardian able and willing to provide written informed consent
- Resides in study area and able to attend all study visits and procedures
- Agree to receive all routine infant and childhood immunizations as per study schedule
- (Cohort 1) Child aged 1 to less than 5 years with documented full polio immunization series completed more than 3 months ago
- (Cohort 2) Infant expected to be 6 weeks old at vaccination with no prior IPV or OPV doses
- (Cohort 3) Newborn aged day of birth plus 3 days with no prior IPV, OPV, or rotavirus vaccination
You will not qualify if you...
- Household has children under 10 years without complete age-appropriate polio vaccination
- Household member received OPV in the 3 months before study vaccination
- Child attends day care or pre-school during study until one month after last vaccination
- Moderate or severe acute illness at enrollment
- Fever (axillary temperature 37.5daC) on enrollment day (Cohorts 1 and 2)
- Known allergy or intolerance to any vaccine components including certain antibiotics
- Clinically significant congenital or genetic defects
- Chronic use of immunosuppressants over 14 days (topical/inhaler steroids allowed unless indicating chronic illness)
- Known or suspected immunodeficiency or immunosuppressive condition in participant or household
- Immune-modifying drugs within 6 months prior to first dose or planned during study
- Known or suspected bleeding disorder
- Severe malnutrition (weight-for-length/height z-score -3 SD)
- Participation in other investigational drug or vaccine trials within 30 days
- Blood product or immunoglobulin transfusion within 12 months prior
- Any condition increasing health risks or interfering with study objectives
- (Cohorts 2 & 3) Low birth weight (<2500g), premature birth (<37 weeks), or multiple birth
AI-Screening
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Trial Site Locations
Total: 1 location
1
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Dhaka, Bangladesh, 1212
Actively Recruiting
Research Team
T
Tushar Tewari, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
15
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