Actively Recruiting
A Phase 2, Randomized, Double-Dummy, Observer-Blind Study to Evaluate the Safety and Immunogenicity of Co-administered Novel Live Attenuated Monovalent Oral Poliomyelitis Vaccines in Healthy Young Infants Relative to Monovalent Vaccines Alone in Panama
Led by PATH · Updated on 2026-01-09
675
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 the safety and immune response of co-administering two novel oral poliomyelitis vaccines, nOPV1 and nOPV2, in healthy infants. The study compares infants receiving both vaccines together to those given each vaccine alone, assessing whether two or three doses of the combined vaccines are as effective as the individual vaccines. This is a Phase 2, randomized, double-dummy, observer-blind study involving infants around 16 weeks old. Participants are randomly assigned to one of three groups: nOPV1 with a placebo, nOPV2 with a placebo, or both nOPV1 and nOPV2 together. Vaccinations are given at 16, 20, and 24 weeks of age. Blood samples for immune testing are collected at these ages and again at 28 weeks to measure antibody responses. Stool samples are also gathered to check for virus shedding after vaccination. During the study, infants are observed for immediate reactions for at least 30 minutes after vaccination. Parents record any local or systemic reactions for 7 days following each dose, while unsolicited side effects are tracked for 28 days after each vaccination. Serious adverse events are monitored throughout the study. The study measures include rates of adverse events and the percentage of infants developing protective antibodies against poliovirus types 1 and 2, with participation lasting until about 28 weeks of age.
CONDITIONS
Brief Title
Study of Co-administered (Types 1 & 2) Novel Oral Poliomyelitis Vaccines Evaluation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male or female infant 16 weeks (+ 7 days) old at first study vaccination
- Parent(s) willing and able to provide written informed consent
- Resides in the study area and can adhere to all study visits and procedures
- Has received routine Expanded Program on Immunization (EPI) vaccines and a single dose of IPV at 6 weeks (+7 days) of age
- Has not received any oral poliovirus vaccine (OPV) doses prior to study vaccination
- Parent agrees for participant to receive routine infant and childhood immunizations per protocol
You will not qualify if you...
- Anyone under 10 years old in the household without complete age-appropriate polio vaccination
- Household member received OPV or investigational nOPV3 vaccine within 3 months before study vaccination
- Low birth weight below 2500 g at birth
- Born prematurely before 37 weeks gestation
- From multiple births
- Moderate or severe acute illness at eligibility or first vaccination
- Fever (axillary temperature 65 37.5dac) on day of first vaccination
- Abnormal vital signs for age on day of first vaccination
- Known allergy or intolerance to any vaccine components or certain antibiotics
- Known or suspected immunosuppressive or immunodeficiency condition in participant or household member
- Use of immune-modifying or immunosuppressant drugs prior to or during study (topical/inhaled steroids allowed)
- Known or suspected bleeding disorder posing risk for injections
- Severe malnutrition (weight-for-length/height z-score < -3SD)
- Receipt of any investigational product prior to or during study
- Receipt of rotavirus vaccine within 2 weeks prior to first vaccination
- Receipt of blood transfusion or immunoglobulins prior to first vaccination
- Any condition increasing health risks or interfering with study objectives as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 10 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 8 weeks
Participants receive three doses of study vaccines or placebo at 16, 20, and 24 weeks of age. Blood and stool samples are collected at multiple timepoints to assess immune response and virus shedding. Reactogenicity and adverse events are monitored following each vaccination.
3 vaccination visits at 16, 20, and 24 weeks of age; blood collected at 16, 20, 24, and 28 weeks; stool samples collected at various timepoints
Duration - 4 weeks
Participants are monitored for adverse events and immune response through 28 days after the last vaccination dose.
Visits for safety monitoring up to 28 days after each vaccination dose
Trial Site Locations
Total: 3 locations
1
Cevaxin - 24 de Diciembre
Panama City, Panama
Actively Recruiting
2
Cevaxin - Ave. México
Panama City, Panama
Actively Recruiting
3
Cevaxin - Chorrera
Panama City, Panama
Actively Recruiting
Research Team
X
Xavier Saez-Llorens
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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