Actively Recruiting
Safety and Efficacy of Whole-Cell Pneumococcal Vaccine (wSp) in Preventing Nasopharyngeal Colonization by Streptococcus Pneumoniae in Young Children
Led by Serum Life Science Europe GmbH · Updated on 2026-06-02
320
Participants Needed
7
Research Sites
52 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
Researchers are evaluating the safety and effectiveness of the whole-cell pneumococcal vaccine (wSp) in healthy young children aged approximately 6 months who have already received routine PCV15 or PCV20 vaccinations. The study aims to find out if the wSp vaccine can reduce the presence of pneumococcal bacteria in the nose and safely trigger the immune system to produce protective responses. This Phase 2 clinical trial is sponsored by Serum Life Science Europe GmbH and focuses on preventing infections such as acute otitis media in children. Participants will be randomly assigned to receive two injections given by intramuscular injection: either the wSp vaccine containing 1 mg total protein or a saline placebo. The first dose is preferably given in the left thigh around 7 months of age, and the second dose in the right thigh around 9 months of age. The vaccine is supplied in single-dose glass vials with aluminum hydroxide as an adjuvant. The study uses a quadruple masking design to compare immune responses and bacterial colonization between the two groups. During the study, children will have blood samples collected at 6 and/or 12 months to measure immune responses and nasal swabs taken at various times between 6 and 24 months to detect pneumococcal colonization and infections. Researchers will monitor for ear infections, respiratory illnesses, and other related infections. The primary outcome is the presence of Streptococcus pneumoniae in the nasopharynx at multiple time points after the second vaccine dose. The total participation period extends up to 24 months of age for observation of infections and immune response.
CONDITIONS
Brief 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 to +75 days) of age at time of enrollment
- Healthy as confirmed by medical history and physical examination
- Received 3 doses of PCV15 or PCV20 vaccine
- Written informed consent from parent or legal guardian
- Parent or guardian willing to bring child to all study visits
You will not qualify if you...
- History of invasive pneumococcal disease confirmed by blood or cerebrospinal fluid culture
- Known or suspected immune system impairment
- History of congenital or acquired immunodeficiency
- Chronic use of immunosuppressants or immune-modifying drugs for more than 14 days
- Receipt of immunoglobulins or blood products since birth or planned during study
- Expected use of systemic corticosteroids within 14 days before any vaccine dose
- External ear canal atresia or stenosis
- Known or history of functional or anatomic asplenia
- Bleeding disorders contraindicating intramuscular injections
- Participation in another clinical trial within 28 days before enrollment or during study
- Child or grandchild of study site personnel
- Fever of 38.0C or higher or acute illness on vaccination day
- Systemic corticosteroid treatment not completed at least 30 days before vaccination (inhaled, topical, or eye steroids allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 months
Participants receive two intramuscular injections of either the wSp vaccine or saline placebo at approximately 7 and 9 months of age.
2 vaccination visits
Duration - Up to 15 months after second dosing
Participants are monitored for occurrences of Streptococcus pneumoniae in the nasopharynx and new serotypes during respiratory infection episodes up to 15 months after the second dose.
Visits at 3, 6, 9, and 15 months after second dose plus visits during respiratory infection episodes
Trial Site Locations
Total: 7 locations
1
Pittsford Pediatrics
Pittsford, New York, United States, 14534
Actively Recruiting
2
Western New York Geneva Pediatrics
Rochester, New York, United States, 14456
Active, Not Recruiting
3
Bay Creek Pediatrics
Rochester, New York, United States, 14580
Active, Not Recruiting
4
Long Pond Pediatrics
Rochester, New York, United States, 14606
Actively Recruiting
5
Rochester Medical Group General Pediatric Associates
Rochester, New York, United States, 14621
Active, Not Recruiting
6
Westside Pediatric Group
Rochester, New York, United States, 14624
Actively Recruiting
7
Panorama Pediatrics
Rochester, New York, United States, 14625
Actively Recruiting
Research Team
M
Marcus May, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here