One polio shot enough? new trial tests simpler vaccine schedule
NCT ID NCT07354269
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 4 study compares a single dose of an inactivated polio vaccine (sIPV) in people aged 7 to 50 years with the standard three-dose series given to infants. Researchers want to see if one shot can produce a similar immune response. The trial is recruiting 180 healthy participants and will monitor safety and antibody levels 30 days after vaccination.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Inactivated polio vaccine (sIPV) and DTaP-IPV-Hib pentavalent vaccine
- What this could lead to
- If successful, this could show that a single polio vaccine dose works as well in older children and adults as the three-dose series given to infants, simplifying booster campaigns.
- What could go wrong
- This is a small, early-phase study comparing different age groups, not a direct test of disease prevention. Results may not apply to all populations or settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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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3 months to 50 years
- 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. Healthy adolescents and adults aged 7-50 years, and healthy infants aged 3 months; 2. Participants and/or their guardians are able to understand and voluntarily sign the informed consent form (for participants aged 7-17 years, both the participant and their guardian need to sign); 3. Provide valid proof of identity; 4. Willing and able to comply with all visit schedules, sample collections, vaccinations, and other study procedures, and remain contactable throughout the study period; 5. Fertile participants and their sexual partners voluntarily adopt effective contraceptive measures from the signing of the informed consent form until 3 months after vaccination with the study vaccine, and have no plans to donate sperm or eggs. Exclusion Criteria: 1. Known history of polio/polio infection. 2. Exposure or suspected exposure to pertussis, diphtheria, and tetanus within the past 30 days, such as having a confirmed case of pertussis or diphtheria in the household (applies to infants aged 3 months). 3. History of uncontrolled chronic or severe illnesses, including but not limited to cardiovascular disease, hematological disorders, liver and kidney diseases, digestive system diseases, respiratory diseases, malignant tumors, and history of major organ transplantation. 4. Presence of autoimmune diseases, immunodeficiency disorders (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection). 5. Abnormal coagulation function (such as coagulation factor deficiency, platelet abnormalities). 6. Premature birth (delivery before the 37th week of gestation) or low birth weight (birth weight \<2500g), or history of asphyxiation, or history of neurological damage (applies to infants aged 3 months). 7. Severe congenital malformations, genetic defects, and malnutrition. 8. Current or past history of severe neurological diseases (epilepsy, convulsions or seizures \[excluding a history of febrile seizures\]) or psychiatric disorders, or family history of psychiatric disorders. 9. Acute exacerbations of various acute or chronic diseases within the past 3 days, or known or suspected active infections. 10. History of vaccination with any vaccine containing DTP, IPV, Hib components, or pneumococcal polysaccharide conjugate vaccine (applies to infants aged 3 months). 11. Received immunosuppressive or other immunomodulatory treatment for ≥14 days within the past 6 months (≥20mg/day of prednisone for those ≥18 years old, ≥2mg/kg/day for those \<18 years old, or equivalent doses), cytotoxic treatment, or plans to receive such treatment during the study. 12. Received immunoglobulin or other blood products within the past 6 months, or plans to receive such treatment during the study. 13. Received other investigational drugs or vaccines within the past 30 days, or plans to receive such drugs or vaccines during the study. 14. Received live attenuated vaccines, nucleic acid vaccines within the past 14 days, or subunit or inactivated vaccines within the past 7 days. 15. Known allergy to any component of the study vaccine (inactivated poliovirus, 199 medium, glycine, sodium chloride, potassium chloride, calcium chloride, magnesium phosphate, disodium phosphate, monosodium phosphate \[for adolescents and adults\]; inactivated poliovirus, diphtheria toxoid, tetanus toxoid, pertussis toxoid, pertussis filamentous hemagglutinin, Haemophilus influenzae type b capsular polysaccharide, tetanus protein conjugate \[for infants aged 3 months\]). 16. Breastfeeding, pregnant, or planning to become pregnant within 3 months after vaccination in this study (applies only to adolescents and adults). 17. Axillary temperature \>37.0°C before vaccination on the day of the planned vaccination with the study vaccine. 18. Unqualified physical examination results on the day of the planned vaccination with the study vaccine. 19. Skin injuries, inflammation, ulcers, rashes, scars, or other conditions at the intended injection site that may interfere with vaccination or observation of local reactions. 20. Any other factors deemed unsuitable for participation in the clinical study by the investigator.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chengguan District Center for Disease Prevention and Control, Lanzhou City
RECRUITINGLanzhou, Gansu, China
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Longxi County Center for Disease Prevention and Control, Dingxi City
RECRUITINGDingxi, Gansu, China
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Zhangye Center for Disease Prevention and Control
RECRUITINGZhangye, Gansu, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can virtual walking trick the brain into easing chronic pain?
- Can a Birth-Dose polio vaccine block the virus in Babies' guts?
- One shot, six protections: could a single vaccine replace multiple infant shots?
- Can a new polio vaccine stop the virus at the throat?
- Can one shot replace six? a new vaccine aims to protect infants from six diseases at once
- One shot, six protections: can a new vaccine match current standards?