NCT07216430

Safety and Efficacy of wSp Vaccine in Young Children

A Phase 2 Study Evaluating the Safety and Efficacy of Whole-Cell Pneumococcal Vaccine (wSp) in Reducing Nasopharyngeal Colonization by Streptococcus Pneumoniae in Young Children.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Serum Life Science Europe GmbH · Industry
• Sex: All
• Age: 5 Months – 7 Months
• Healthy volunteers: Accepted

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 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 7 and 9 months of age. Have blood samples taken at 6 and 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.

Conditions

• Acute Otitis Media (AOM)

Interventions

Type	Name	Description
BIOLOGICAL	wSp vaccine	wSp vaccine will be administered as intramuscular (IM) injections of 0.5 mL (thus 1 mg total protein). wSp vaccine is supplied as single-dose glass vials in saline (0.9% sodium chloride) at 2 mg protein/mL, with aluminum hydroxide at 1.2 mg elemental Al/mL. Dose 1 will be given in the left thigh at 7 months of age, and dose 2 will be given in the right thigh at 9 months of age.
BIOLOGICAL	Saline (0.9% NaCl)	Saline will be administered as intramuscular (IM) injections of 0.5 mL. Dose 1 will be given in the left thigh at 7 months of age and dose 2 will be given in the right thigh at 9 months of age.

Timeline

• Start date: 2025-09-29
• Primary completion: 2028-06-01
• Completion: 2029-06-01
• First posted: 2025-10-14
• Last updated: 2026-03-13

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study