wSp vaccine to prevent pneumococcal colonization in young children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial gives healthy infants two injections of either the wSp vaccine or a saline placebo at about 7 and 9 months of age. Blood samples are taken at 6 and 12 months to measure antibody and immune responses, and nasal swabs are collected at multiple time points and during respiratory infections through 24 months to track pneumococcal colonization. Investigators will monitor for ear infections, respiratory illnesses, and other pneumococcal-related outcomes to evaluate safety and impact on carriage. Participants were limited to infants who previously received three doses of PCV20 and who meet standard health and immunologic criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female who is 6 months (- 30 to +75 days) of age at time of enrollment
2. Healthy subject as established by medical history and clinical examination before entering into the study.
3. Received 3 doses of PCV15 or PCV20.
4. Written informed consent obtained from the subject's parent/legal guardian.
5. Parent/legal guardian able and willing to bring subject to all study visits.

Exclusion Criteria:

1. Has a history of invasive pneumococcal disease (positive blood culture and/or positive cerebrospinal fluid culture).
2. Known or suspected impairment of immunological function, based on medical history and physical examination.
3. Has a history of congenital or acquired immunodeficiency.
4. Chronic administration (defined \> 14 consecutive days) of immunosuppressants or other immune-modifying drugs.
5. Prior receipt since birth of immunoglobulins and/or any blood products or planned administration during the study period.
6. Expected to receive systemic corticosteroids within 14 days prior to any dose of study vaccine.
7. External auditory canal atresia/stenosis.
8. Has known or history of functional or anatomic asplenia.
9. Has a bleeding disorder in which intramuscular vaccination would be contraindicated.
10. Participation in another investigational or interventional trial within the 28-day period before enrollment and during the conduct of the study. Participation in observational studies is permitted.
11. Direct descendant (child or grandchild) of study site personnel.

    Temporary exclusion criteria

    For day of vaccination:
12. Fever (transcutaneous temperature ≥38.0°C) or acute illness, at investigator's discretion
13. Has received systemic corticosteroids (equivalent of prednisone \> 0.5 mg/kg/day or equivalent) and not completed this course of treatment at least 30 days prior to the study vaccination. Inhaled, topical, and ophthalmic steroids are allowed.

Where it's running

• Pittsford Pediatrics
  Pittsford, New York, United States Recruiting
• Long Pond Pediatrics
  Rochester, New York, United States Recruiting
• Westside Pediatric Group
  Rochester, New York, United States Recruiting
• Panorama Pediatrics
  Rochester, New York, United States Recruiting
• Western New York Geneva Pediatrics
  Rochester, New York, United States Active not recruiting
• Bay Creek Pediatrics
  Rochester, New York, United States Active not recruiting

Study contacts

• Study coordinator: Marcus May, MD
• Email: may@sls-eu.com
• Phone: +49 511 16 99 08 0

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.