Actively Recruiting
Study of a Novel Type 3 Oral Poliomyelitis Vaccine in Panama
Led by PATH · Updated on 2026-05-11
1532
Participants Needed
3
Research Sites
171 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 3 vaccine, nOPV3, as compared to Sabin monovalent type 3 vaccine controls (mOPV3), in healthy young children (192 subjects), infants (860 subjects), and neonates (480 subjects).
CONDITIONS
Official Title
Study of a Novel Type 3 Oral Poliomyelitis Vaccine in Panama
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy with no significant medical conditions or congenital anomalies
- Parent or guardian willing to provide written informed consent
- Resides in study area and able to attend all study visits and procedures
- Parent or guardian agrees to routine infant and childhood immunizations per protocol
- Children 1 to under 5 years old who completed primary polio immunization series more than 28 days before vaccination (cohort 1)
- Infants expected to be 6 weeks old at vaccination with no prior polio vaccination (cohort 2)
- Newborns within 3 days of birth with no prior polio vaccination (cohort 3)
You will not qualify if you...
- Household members under 10 years old without complete age-appropriate polio vaccination
- Household members who received OPV in the past 3 months
- Children attending daycare or preschool during the study until one month after last vaccination
- Moderate or severe acute illness at enrollment (temporary exclusion)
- Fever above 37.5°C at enrollment (temporary exclusion for cohorts 1 and 2)
- Known allergy or intolerance to vaccine components or certain antibiotics
- Known or suspected immunosuppressive or immunodeficiency conditions in participant or household
- Use of immunosuppressive drugs by participant or household member
- Known or suspected bleeding disorders posing risk to injections or blood draws
- Severe malnutrition (temporary exclusion if marginal and later improves)
- Participation in another investigational trial or receipt of investigational products within 30 days
- Receipt of blood transfusion or immunoglobulins within 12 months
- Any condition increasing health risks or interfering with study participation
- Premature birth under 37 weeks or under 2500 grams (cohorts 2 and 3 only)
- Multiple birth (twins or more) due to risk of virus transmission between siblings (cohorts 2 and 3 only)
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Cevaxin - 24 de Diciembre
Panama City, Panama
Actively Recruiting
2
Cevaxin - Chorrera
Panama City, Panama
Actively Recruiting
3
Cevaxin-- Avenida Mexico
Panama City, Panama
Actively Recruiting
Research Team
X
Xavier Saez-Llorens, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
12
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