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New vaccine aims to stop pneumococcal bacteria in Kids' noses

NCT ID NCT07216430

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 320 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

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

5 to 7 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Bay Creek Pediatrics

    ACTIVE_NOT_RECRUITING

    Rochester, New York, 14580, United States

  • Long Pond Pediatrics

    RECRUITING

    Rochester, New York, 14606, United States

  • Panorama Pediatrics

    RECRUITING

    Rochester, New York, 14625, United States

  • Pittsford Pediatrics

    RECRUITING

    Pittsford, New York, 14534, United States

  • Rochester Medical Group General Pediatric Associates

    ACTIVE_NOT_RECRUITING

    Rochester, New York, 14621, United States

  • Western New York Geneva Pediatrics

    ACTIVE_NOT_RECRUITING

    Rochester, New York, 14456, United States

  • Westside Pediatric Group

    RECRUITING

    Rochester, New York, 14624, United States

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Other studies related to the condition(s) this trial covers.