Actively Recruiting
Safety and Efficacy of wSp Vaccine in Young Children
Led by Serum Life Science Europe GmbH · Updated on 2026-04-28
320
Participants Needed
4
Research Sites
191 weeks
Total Duration
On this page
Sponsors
S
Serum Life Science Europe GmbH
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Safety and Efficacy of wSp Vaccine in Young Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female who is 6 months (+/- 30 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 PCV-20
- 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 will not qualify if you...
- History of invasive pneumococcal disease confirmed by positive blood or cerebrospinal fluid culture
- Known or suspected immunological impairment
- History of congenital or acquired immunodeficiency
- Chronic use of immunosuppressants or immune-modifying drugs for more than 14 consecutive days or during the study
- Prior receipt since birth of immunoglobulins or blood products or planned administration during the study
- Expected systemic corticosteroid use within 14 days before any vaccine dose
- External auditory canal atresia or stenosis
- Known or history of functional or anatomic asplenia
- Bleeding disorder contraindicating intramuscular vaccination
- Participation in another investigational trial within 28 days before enrollment or during the study (observational studies allowed)
- Direct descendant of study site personnel
- Fever (temperature ≥38.0°C) or acute illness on vaccination day
- Recent systemic corticosteroid treatment not completed at least 30 days before vaccination (inhaled, topical, and ophthalmic steroids allowed)
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Trial Site Locations
Total: 4 locations
1
Western New York Geneva Pediatrics
Rochester, New York, United States, 14456
Actively Recruiting
2
Bay Creek Pediatrics
Rochester, New York, United States, 14580
Active, Not Recruiting
3
Rochester Medical Group General Pediatric Associates
Rochester, New York, United States, 14621
Active, Not Recruiting
4
Panorama Pediatrics
Rochester, New York, United States, 14625
Actively Recruiting
Research Team
M
Marcus May, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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