NCT07216430 · Serum Life Science Europe GmbH
Safety and Efficacy of wSp Vaccine in Young Children
(wSp005)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female who is 6 months (- 30 to +75 days) of age at time of enrollment
- Healthy subject as established by medical history and clinical examination before entering into the study.
- Received 3 doses of PCV15 or PCV20.
- Written informed consent obtained from the subject's parent/legal guardian.
- Parent/legal guardian able and willing to bring subject to all study visits.
Exclusion criteria
- Has a history of invasive pneumococcal disease (positive blood culture and/or positive cerebrospinal fluid culture).
- Known or suspected impairment of immunological function, based on medical history and physical examination.
- Has a history of congenital or acquired immunodeficiency.
- Chronic administration (defined \> 14 consecutive days) of immunosuppressants or other immune-modifying drugs.
- Prior receipt since birth of immunoglobulins and/or any blood products or planned administration during the study period.
- Expected to receive systemic corticosteroids within 14 days prior to any dose of study vaccine.
- External auditory canal atresia/stenosis.
- Has known or history of functional or anatomic asplenia.
- Has a bleeding disorder in which intramuscular vaccination would be contraindicated.
- 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.
- Direct descendant (child or grandchild) of study site personnel. Temporary exclusion criteria For day of vaccination:
- Fever (transcutaneous temperature ≥38.0°C) or acute illness, at investigator's discretion
- 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
- Pittsford, New York
- Rochester, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 2, 2026 · Source of record for eligibility and locations