Actively Recruiting
Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines
Led by PATH · Updated on 2025-06-03
2400
Participants Needed
2
Research Sites
160 weeks
Total Duration
On this page
Sponsors
P
PATH
Lead Sponsor
B
Bio Farma, Indonesia
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main objectives of this study are to : * evaluate the safety and tolerability of trivalent novel oral poliovirus vaccines (tnOPV) in healthy adults, young children, and neonates, relative to those receiving control vaccines; * evaluate the safety and tolerability of combined novel oral poliovirus vaccine type 1 (nOPV1) + novel oral poliovirus vaccine type 2 (nOPV2) in neonates, relative to those receiving the bivalent (types 1 and 3) oral poliovirus vaccine (bOPV) control. * compare type-specific cumulative seroconversion rates of poliovirus neutralizing antibody (NAb) titers, among all tnOPV dose combinations, following 4 vaccinations in healthy neonates; * evaluate the type-specific cumulative seroconversion rate of poliovirus NAb titers among healthy neonates following 4 doses of combined nOPV1+nOPV2.
CONDITIONS
Official Title
Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy with no significant medical conditions or birth defects
- Willing and able to provide written informed consent
- Resides and plans to remain in study area and can follow study visits and procedures
- Adults 18 to 45 years old (Cohort 1)
- Females of childbearing potential not pregnant or breastfeeding and agree to use contraception (Cohort 1)
- Born and raised in Bangladesh in 1990 or later or documented full polio immunization if born before 1990 (Cohort 1)
- Children 1 to less than 5 years old with documented 3 or 4 dose primary polio immunization series with last dose over 3 months ago (Cohort 2)
- Newborn neonates within 3 days of birth with no prior polio or rotavirus vaccines (Cohort 3)
- Agreement to receive polio vaccines under modified schedule (Cohort 3)
You will not qualify if you...
- Household members under 10 years old not fully vaccinated for polio
- Allergy or intolerance to vaccine components or related antibiotics
- Known or suspected immunosuppressive or immunodeficiency conditions in participant or household
- Use or planned use of immune-modifying or immunosuppressant drugs within 6 months prior or during study
- Bleeding disorders posing risk for injections or blood draws
- Moderate or severe acute illness including vomiting or diarrhea at enrollment
- Fever within 72 hours before enrollment or vaccination or recent antipyretic use
- Major congenital or genetic defects
- History of chronic immunosuppressant medication use (except topical/inhaled steroids)
- Participation in another investigational product trial within 30 days prior or planned during study
- Blood transfusion or immunoglobulin receipt within 12 months prior or planned during study
- Any condition increasing health risks or interfering with study adherence
- Adults vaccinated for polio within past 12 months
- Adults with Crohn's disease, ulcerative colitis, major bowel surgery
- Adults with close contact with pregnant women, young children under 2, or individuals with fecal incontinence
- Adults professionally handling food
- Children attending daycare or preschool during study and one month after last vaccination
- Children with severe malnutrition
- Newborns with low birth weight under 2500 g
- Premature birth under 37 weeks gestation
- Multiple births (twins, triplets, etc.)
AI-Screening
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Trial Site Locations
Total: 2 locations
1
International Centre for Diarrhoeal Disease Research
Dhaka, Bangladesh, 1212
Not Yet Recruiting
2
International Centre for Diarrhoeal Disease Research
Dhaka, Bangladesh
Actively Recruiting
Research Team
N
Nicole Grunenberg, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
14
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