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Study identifier: NCT07216430 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Safety and Efficacy of wSp Vaccine in Young Children

Condition: Acute Otitis Media (AOM)  ·  Sponsor: Serum Life Science Europe GmbH

PhasePhase 2
Planned participants320
Who can joinAll sexes, 5 Months to 7 Months
Healthy volunteersYes

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Marcus May, MD  ·  +49 511 16 99 08 0  ·  may@sls-eu.com

Always discuss trial participation with your own doctor first.

Locations (7)

Pittsford PediatricsPittsford, New York, United StatesRecruiting
Western New York Geneva PediatricsRochester, New York, United StatesActive Not Recruiting
Bay Creek PediatricsRochester, New York, United StatesActive Not Recruiting
Long Pond PediatricsRochester, New York, United StatesRecruiting
Rochester Medical Group General Pediatric AssociatesRochester, New York, United StatesActive Not Recruiting
Westside Pediatric GroupRochester, New York, United StatesRecruiting
Panorama PediatricsRochester, New York, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT07216430