Actively Recruiting
Study of Co-administered (Types 1 & 2) Novel Oral Poliomyelitis Vaccines Evaluation
Led by PATH · Updated on 2026-01-09
675
Participants Needed
3
Research Sites
58 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 study is to evaluate the safety and tolerability of co-administration of nOPV1 + nOPV2 in infants, relative to those receiving monovalent nOPV vaccines alone and whether two and/or three doses of co-administered nOPV1 and nOPV2 are non-inferior to corresponding doses of nOPV1 alone and nOPV2 alone.
CONDITIONS
Official 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 vaccination with no significant medical conditions or birth defects
- Parent(s) able and willing to provide written informed consent before study procedures
- Participant resides in study area and parent agrees to follow all study visits and procedures
- Received routine Expanded Program on Immunization (EPI) vaccines and a single dose of IPV at 6 weeks (+7 days) of age before study vaccination
- No prior oral polio vaccine (OPV) doses received before study vaccination
- Parent agrees for participant to receive routine infant and childhood immunizations per study schedule
You will not qualify if you...
- Anyone under 10 years old in the household lacks complete age-appropriate polio vaccination at study vaccination time
- Household member received OPV or investigational nOPV3 vaccine within 3 months before study vaccination
- Low birth weight less than 2500 g at birth
- Born prematurely before 37 weeks gestation
- Multiple birth status due to increased risk of vaccine transmission
- Moderate or severe acute illness (grade 2 or higher) at eligibility or first vaccination; mild illness may be allowed at investigator's discretion
- Fever (axillary temperature 637.5daC) on day of randomization or first vaccination
- Abnormal vital signs (respiratory or heart rate) for age on day of randomization or first vaccination
- Known allergy or intolerance to vaccine components including macrolide and aminoglycoside antibiotics
- Known or suspected immunosuppressive or immunodeficiency conditions in participant or household members
- Use of immune-modifying or immunosuppressant drugs before or planned during study (except topical or inhaled steroids)
- Known or suspected bleeding disorder that increases risk from injections or blood draws
- Severe malnutrition defined by weight-for-length/height z-score below -3 SD; temporary exclusion if marginal and improves
- Prior receipt or planned use of any investigational products during study
- Receipt of rotavirus vaccine within 2 weeks prior to first vaccination
- Prior receipt of investigational poliovirus vaccine
- Receipt or planned use of blood products or immunoglobulins during study
- Any condition that, in investigator's opinion, increases health risks or affects study adherence or outcomes
AI-Screening
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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
CONTACT
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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