Safety and Efficacy of wSp Vaccine in Young Children

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.

NCT Number	NCT07216430
Lead Sponsor	Serum Life Science Europe GmbH Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), Rochester General Hospital, Serum Institute of India Pvt. Ltd., Alira Health
Conditions	Acute Otitis Media (AOM)
Enrollment	320 participants
Start Date	2025-09-29
Primary Completion	2028-06 (estimated)
Study Completion	2029-06 (estimated)
Updated on ClinicalTrials.gov	2026-06-02