New vaccine aims to stop pneumococcal bacteria in Kids' noses
NCT ID NCT07216430
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new whole-cell pneumococcal vaccine (wSp) in healthy children aged around 7 to 9 months who already received standard pneumonia vaccines. The goal is to see if wSp reduces pneumococcal bacteria in the nose and boosts immune protection. Researchers will compare children who get the vaccine with those who get a placebo, tracking infections and immune responses over 24 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Whole-cell pneumococcal vaccine (wSp)
- What this could lead to
- If it works, this could lead to a vaccine that reduces pneumococcal bacteria in the nose and may help prevent ear infections and other related illnesses in children.
- What could go wrong
- This is an early phase 2 trial with 320 children, so results are not yet proven. The vaccine may not reduce bacteria as hoped, and side effects are possible.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 320 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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Jun 2029
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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5 to 7 months
- 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. Male or female who is 6 months (- 30 to +75 days) of age at time of enrollment 2. Healthy subject as established by medical history and clinical examination before entering into the study. 3. Received 3 doses of PCV15 or PCV20. 4. Written informed consent obtained from the subject's parent/legal guardian. 5. Parent/legal guardian able and willing to bring subject to all study visits. Exclusion Criteria: 1. Has a history of invasive pneumococcal disease (positive blood culture and/or positive cerebrospinal fluid culture). 2. Known or suspected impairment of immunological function, based on medical history and physical examination. 3. Has a history of congenital or acquired immunodeficiency. 4. Chronic administration (defined \> 14 consecutive days) of immunosuppressants or other immune-modifying drugs. 5. Prior receipt since birth of immunoglobulins and/or any blood products or planned administration during the study period. 6. Expected to receive systemic corticosteroids within 14 days prior to any dose of study vaccine. 7. External auditory canal atresia/stenosis. 8. Has known or history of functional or anatomic asplenia. 9. Has a bleeding disorder in which intramuscular vaccination would be contraindicated. 10. Participation in another investigational or interventional trial within the 28-day period before enrollment and during the conduct of the study. Participation in observational studies is permitted. 11. Direct descendant (child or grandchild) of study site personnel. Temporary exclusion criteria For day of vaccination: 12. Fever (transcutaneous temperature ≥38.0°C) or acute illness, at investigator's discretion 13. Has received systemic corticosteroids (equivalent of prednisone \> 0.5 mg/kg/day or equivalent) and not completed this course of treatment at least 30 days prior to the study vaccination. Inhaled, topical, and ophthalmic steroids are allowed.
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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
4 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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Bay Creek Pediatrics
ACTIVE_NOT_RECRUITINGRochester, New York, 14580, United States
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Long Pond Pediatrics
RECRUITINGRochester, New York, 14606, United States
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Panorama Pediatrics
RECRUITINGRochester, New York, 14625, United States
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Pittsford Pediatrics
RECRUITINGPittsford, New York, 14534, United States
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Rochester Medical Group General Pediatric Associates
ACTIVE_NOT_RECRUITINGRochester, New York, 14621, United States
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Western New York Geneva Pediatrics
ACTIVE_NOT_RECRUITINGRochester, New York, 14456, United States
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Westside Pediatric Group
RECRUITINGRochester, New York, 14624, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could an AI device replace the Doctor's visit for kids with ear infections and asthma?
- New study aims to curb antibiotic overuse for coughs and colds
- New program aims to cut unnecessary antibiotics for kids by training doctors and giving feedback
- AI takes on ear infections: could cut unnecessary antibiotics in kids
- New vaccine shows promise against childhood ear infections