Safety and Efficacy of wSp Vaccine in Young Children

Recruiting now · Phase 2

Conditions studied: Acute Otitis Media (AOM)

In brief

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? Does wSp vaccine safely stimulate the immune system to produce antibodies and protective immune responses? Researchers will compare children receiving two injections of wSp vaccine to those receiving saline placebo to see if wSp vaccine reduces colonization and boosts immunity. Participants will: Receive two injections of either wSp or saline at approximately 7 and 9 months of age. Have blood samples taken at 6 and/or 12 months to measure immune responses. Have nasal swabs collected at several time points and during infections from 6-24 months. Be monitored for ear infections, respiratory illnesses, and other pneumococcal-related infections.

Key facts

Study ID

NCT07216430

Run by

Serum Life Science Europe GmbH

People needed

320

Starts

2025-09-29

Expected to finish

2029-06-01

Last updated by the study team

2026-06-02

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify 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 may not qualify 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.
• 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, 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 ophthalmic steroids are allowed.

Where it is running

• Long Pond Pediatrics — Rochester, New York, United States (enrolling)
• Pittsford Pediatrics — Pittsford, New York, United States (enrolling)
• Westside Pediatric Group — Rochester, New York, United States (enrolling)
• Panorama Pediatrics — Rochester, New York, United States (enrolling)
• Western New York Geneva Pediatrics — Rochester, New York, United States
• Bay Creek Pediatrics — Rochester, New York, United States
• Rochester Medical Group General Pediatric Associates — Rochester, New York, United States

Full record on ClinicalTrials.gov

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