Status:
RECRUITING
Safety and Efficacy of wSp Vaccine in Young Children
Lead Sponsor:
Serum Life Science Europe GmbH
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Rochester General Hospital
Conditions:
Acute Otitis Media (AOM)
Eligibility:
All Genders
5-7 years
Phase:
PHASE2
Brief Summary
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 PCV20 vaccin...
Eligibility Criteria
Inclusion
- Male or female who is 6 months (+/- 30 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 PCV-20.
- Written informed consent obtained from the subject's parent/legal guardian.
- Parent/legal guardian able and willing to bring subject to all study visits.
Exclusion
- 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, or during the study period.
- 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 interventional 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
- 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.
Key Trial Info
Start Date :
September 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT07216430
Start Date
September 29 2025
End Date
June 1 2029
Last Update
October 14 2025
Active Locations (4)
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1
Western New York Geneva Pediatrics
Rochester, New York, United States, 14456
2
Bay Creek Pediatrics
Rochester, New York, United States, 14580
3
Rochester Medical Group General Pediatric Associates
Rochester, New York, United States, 14621
4
Panorama Pediatrics
Rochester, New York, United States, 14625