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Tests treatment safety and results for Acute Otitis Media (AOM)
Official title Safety and Efficacy of wSp Vaccine in Young Children
ClinicalTrials.gov ID: NCT07216430
What this study is testing
What is wSp vaccine?
wSp vaccine is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for acute otitis media (aom).
Also referred to as SPWCV, PATH-wSP.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to evaluate whether the wSp vaccine can prevent nasopharyngeal colonization by pneumococcal bacteria in healthy young children who have received routine PCV15 or PCV20 vaccination. The main questions it aims to answer are: Does wSp vaccine reduce pneumococcal colonization in the nose?
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 7. Healthy volunteers may be eligible.
You may be able to join if
- Male or female who is 6 months (- 30 to +75 days) of age at time of enrollment
- Healthy subject as established by medical history and clinical examination before entering into the study.
- Received 3 doses of PCV15 or PCV20.
- Written informed consent obtained from the subject's parent/legal guardian.
- Parent/legal guardian able and willing to bring subject to all study visits.
You likely can't join if
- Has a history of invasive pneumococcal disease (positive blood culture and/or positive cerebrospinal fluid culture).
- Known or suspected impairment of immunological function, based on medical history and physical examination.
- Has a history of congenital or acquired immunodeficiency.
- Chronic administration (defined \> 14 consecutive days) of immunosuppressants or other immune-modifying drugs.
- Prior receipt since birth of immunoglobulins and/or any blood products or planned administration during the study period.
- Expected to receive systemic corticosteroids within 14 days prior to any dose of study vaccine.
See the full eligibility criteria
- Male or female who is 6 months (- 30 to +75 days) of age at time of enrollment
- Healthy subject as established by medical history and clinical examination before entering into the study.
- Received 3 doses of PCV15 or PCV20.
- Written informed consent obtained from the subject's parent/legal guardian.
- Parent/legal guardian able and willing to bring subject to all study visits.
- Has a history of invasive pneumococcal disease (positive blood culture and/or positive cerebrospinal fluid culture).
- Known or suspected impairment of immunological function, based on medical history and physical examination.
- Has a history of congenital or acquired immunodeficiency.
- Chronic administration (defined \> 14 consecutive days) of immunosuppressants or other immune-modifying drugs.
- Prior receipt since birth of immunoglobulins and/or any blood products or planned administration during the study period.
- Expected to receive systemic corticosteroids within 14 days prior to any dose of study vaccine.
- External auditory canal atresia/stenosis.
- Has known or history of functional or anatomic asplenia.
- Has a bleeding disorder in which intramuscular vaccination would be contraindicated.
- Participation in another investigational or treatment trial within the 28-day period before enrollment and during the conduct of the study. Participation in observational studies is permitted.
- Direct descendant (child or grandchild) of study site personnel. Temporary exclusion criteria For day of vaccination:
- Fever (transcutaneous temperature ≥38.0°C) or acute illness, at investigator's discretion
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Pittsford, New York, United States
- Rochester, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 months to 7 months. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsford, New York, United States; Rochester, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.