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Safety and Efficacy of wSp Vaccine in Young Children
NCT07216430 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- BIOLOGICAL wSp vaccine
- BIOLOGICAL Saline (0.9% NaCl)
Study Locations (4)
New York
- Western New York Geneva Pediatrics — Rochester
- Bay Creek Pediatrics — Rochester
- Rochester Medical Group General Pediatric Associates — Rochester
- Panorama Pediatrics — Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2025-09-29 |
| Est. Completion | 2029-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07216430
The ClinicalTrials.gov registry entry for NCT07216430 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Serum Life Science Europe, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Acute Otitis Media (AOM) appearing as the primary indexed condition, and to 2 interventions — of which wSp vaccine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07216430 reports 4 study locations spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07216430 about?
NCT07216430 is a clinical study titled "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 PCV20 vaccination. The main questions it aims to answer are: Does wSp vaccine reduce pneumococcal colonization...
What is the current status of trial NCT07216430?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 320 participants. The study started on 2025-09-29. Estimated completion is 2029-06.
What conditions does trial NCT07216430 study?
This clinical trial studies the following conditions: Acute Otitis Media (AOM). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07216430?
The interventions under investigation include: wSp vaccine (BIOLOGICAL), Saline (0.9% NaCl) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07216430?
This trial is sponsored by Serum Life Science Europe, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07216430 being conducted?
This trial has 4 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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