Safety and Efficacy of wSp Vaccine in Young Children
Start Date
9/29/2025
Completion Date
6/1/2029
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 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.
Eligibility Criteria
Age Range: No minimum to No maximum
Interventions
wSp vaccine
Saline (0.9% NaCl)
Conditions
Locations
Pittsford Pediatrics
Pittsford, New York 14534
United States
Western New York Geneva Pediatrics
Rochester, New York 14456
United States
Bay Creek Pediatrics
Rochester, New York 14580
United States
Long Pond Pediatrics
Rochester, New York 14606
United States
Rochester Medical Group General Pediatric Associates
Rochester, New York 14621
United States
Westside Pediatric Group
Rochester, New York 14624
United States
Panorama Pediatrics
Rochester, New York 14625
United States