Safety and Efficacy of wSp Vaccine in Young Children
Public ClinicalTrials.gov record NCT07216430. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2 Study Evaluating the Safety and Efficacy of Whole-Cell Pneumococcal Vaccine (wSp) in Reducing Nasopharyngeal Colonization by Streptococcus Pneumoniae in Young Children.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07216430
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 320 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 5 Months to 7 Months
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 28, 2025
- Primary completion
- May 31, 2028
- Completion
- May 31, 2029
- Last update posted
- Jun 1, 2026
2025 – 2029
United States locations
- U.S. sites
- 7
- U.S. states
- 1
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pittsford Pediatrics | Pittsford | New York | 14534 | Recruiting |
| Western New York Geneva Pediatrics | Rochester | New York | 14456 | Active, not recruiting |
| Bay Creek Pediatrics | Rochester | New York | 14580 | Active, not recruiting |
| Long Pond Pediatrics | Rochester | New York | 14606 | Recruiting |
| Rochester Medical Group General Pediatric Associates | Rochester | New York | 14621 | Active, not recruiting |
| Westside Pediatric Group | Rochester | New York | 14624 | Recruiting |
| Panorama Pediatrics | Rochester | New York | 14625 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07216430, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 1, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07216430 live on ClinicalTrials.gov.