Actively Recruiting
A Phase 2, Randomized, Observer-Blind, Controlled, Age De-escalation, Dosage Escalation Study to Assess the Safety and Immunogenicity of a Novel Live Attenuated Type 3 Oral Poliomyelitis Vaccine in Healthy Young Children, Infants, and Neonates in Panama
Led by PATH · Updated on 2026-05-11
1532
Participants Needed
3
Research Sites
N/A
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
Researchers are evaluating a new oral polio type 3 vaccine called nOPV3 in healthy young children, infants, and newborns. This phase 2, randomized, observer-blind study aims to assess the safety, immune response, virus shedding, and potential neurovirulence of nOPV3 compared to the Sabin monovalent type 3 vaccine (mOPV3). The study will enroll 192 young children aged 1 to under 5 years, 860 infants around 6 weeks old, and 480 neonates at birth plus 3 days. Participants will be grouped by age and receive different doses of nOPV3 or mOPV3 vaccines. Young children will receive two doses 28 days apart. Infants will first get an inactivated poliomyelitis vaccine (IPV) dose, then two doses of nOPV3 or mOPV3, followed by a challenge dose of mOPV3. Neonates will receive two doses of either nOPV3 or mOPV3. Dose levels will be escalated across groups, with progress dependent on safety data from prior adult and pediatric cohorts. Throughout the study, researchers will monitor serious and mild side effects, immune response through blood tests, virus shedding in stool samples, and genetic stability of the vaccine virus using specialized tests. Participants will have multiple visits for vaccinations, assessments, and sample collections over approximately 18 months. Safety and immune responses will be carefully tracked to understand the vaccine's effects in these age groups.
CONDITIONS
Brief 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
- Agrees to receive all routine infant and childhood immunizations per schedule
- For young children (cohort 1): aged 1 to under 5 years
- Completed primary poliomyelitis immunization series more than 28 days prior
- For infants (cohort 2): age around 6 weeks, not previously vaccinated with IPV or OPV
- For neonates (cohort 3): newborns (birth plus 3 days), not previously vaccinated with IPV or OPV
You will not qualify if you...
- Household members under 10 years old without complete polio vaccination
- Household members who received OPV within 3 months before study vaccination
- Attending day care or pre-school during study until 1 month after last vaccination
- Moderate or severe acute illness at enrollment
- Fever above 37.5°C on enrollment day (temporary exclusion if resolved in 48 hours)
- Allergy or intolerance to vaccine components including certain antibiotics
- Known or suspected immunosuppressive or immunodeficiency conditions in participant or household members
- Use of systemic immune-modifying or immunosuppressant drugs by participant or household members
- Known or suspected bleeding disorders posing risk to injections or blood draws
- Severe malnutrition (weight-for-length/height z-score ≤ -3SD)
- Participation in another investigational product trial within 30 days
- Blood transfusions or immunoglobulins within 12 months prior to vaccination
- Any condition increasing health risks or interfering with study objectives
- For infants and neonates: premature birth under 37 weeks or less than 2500 grams
- Multiple births in infants and neonates due to transmission risk between siblings
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 16 weeks
Participants receive doses of the oral poliomyelitis vaccine or control vaccine according to their assigned group, with multiple doses administered over several weeks.
2 to 3 vaccination visits depending on cohort, plus a challenge dose visit for infants
Duration - Up to 18 months
Participants are monitored for safety and immunogenicity after vaccination, including assessments of adverse events and antibody responses.
Multiple visits for safety and immunogenicity assessments across the study period
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
12
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here