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NCT07216430 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of wSp Vaccine in Young Children
A Phase 2 study of Acute Otitis Media (AOM), sponsored by Serum Life Science Europe.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 320
- Enrollment target
- 4
- Study locations
NCT07216430 is a Phase 2 study of Acute Otitis Media (AOM) that is actively recruiting participants, run by Serum Life Science Europe. The registered enrollment target is 320 participants. The trial reports 4 study locations across 1 state.
The verdict
NCT07216430, a Phase 2 study of Acute Otitis Media (AOM), is actively recruiting participants, sponsored by Serum Life Science Europe.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 320 participants
- Enrollment target
- 4
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. 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 2 total studies on file at ClinicalTrials.gov.
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.
NCT07216430 reports 4 study locations spanning 1 distinct geographic area - top geographies include New York.
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).
What interventions are being tested in trial NCT07216430?
The interventions under investigation include: wSp vaccine (BIOLOGICAL), Saline (0.9% NaCl) (BIOLOGICAL).
Who is sponsoring clinical trial NCT07216430?
This trial is sponsored by Serum Life Science Europe, which has 2 total clinical trials registered on ClinicalTrials.gov.
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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