Can a new polio vaccine stop the virus at the throat?
NCT ID NCT05677256
First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This trial tests how well two polio vaccines protect the throat against poliovirus type-2. Healthy infants receive either bivalent oral polio vaccine (bOPV) or inactivated polio vaccine (IPV) in the first months of life. At 18 weeks, all infants get a dose of a newer oral polio vaccine (nOPV2) as a challenge. Researchers then measure virus shedding and antibodies in throat samples over four weeks to compare mucosal immunity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- novel oral polio vaccine type 2 (nOPV2) as a challenge dose
- What this could lead to
- If throat immunity differs between vaccine types, this could guide future polio vaccination strategies to better block virus spread.
- What could go wrong
- This is a phase 4 study in healthy infants, and results may not reflect real-world transmission. The challenge vaccine is safe but may cause mild side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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501 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Aug 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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5 to 8 weeks
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Infants aged 6 to 8 weeks with birth weight \>2,500 g. 2. Healthy infants without obvious medical conditions like immunodeficiency diseases, severe congenital malformations, severe neurological diseases or any other disease that require high doses of corticosteroids or immunotherapies that preclude the subject from participating in the study as established by the medical history and physical examination. 3. Written informed consent obtained from both parents or legal guardian(s) as per country regulations. Exclusion Criteria: 1. Infants who have received previous vaccination against poliomyelitis. 2. Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus infection in the potential participant or any member of the subject's household. 3. Family history of congenital or hereditary immunodeficiency. 4. Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine). 5. Known allergy to any component of the study vaccines or to any antibiotics that share molecular composition with a component of the study vaccines. 6. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections (of IPV) 7. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. 8. Acute severe febrile illness on the day of vaccination deemed by the Investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all inclusion criteria are met.). 9. Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject. 10. Infants from multiple births or born prematurely (\< 37 weeks of gestation).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
International Centre for Diarrhoeal Diseases Research
Dhaka, 1212, Bangladesh
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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