> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/safety-and-efficacy-of-wsp-vaccine-in-young-children-32e31d57-dfa4-4d59-8909-0b5cc8bbd248 > Record changed: 2026-11-04 # Safety and Efficacy of wSp Vaccine in Young Children NCT07216430 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) Participants 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) Lead sponsor Serum Life Science Europe GmbH Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) Start date 2025-09-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) Number of sites 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) ## Title and summary **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 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) **Acronym** wSp005 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) **Short title** Safety and Efficacy of wSp Vaccine in Young Children Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) ## Dates **Completion date** 2029-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) **First posted** 2025-10-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) **Registry last updated** 2026-09-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) **Primary completion date** 2028-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) **Start date** 2025-09-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) ## Size and sites **Participants** 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) **Planned participants** 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) **Number of sites** 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) **Lead sponsor** Serum Life Science Europe GmbH Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) ## Identifiers **Registry ID** NCT07216430 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) **ClinicalTrials.gov ID** NCT07216430 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masking description** Only the person administering the investigational product will be unmasked. This person does not perform any other participant-related tasks in the clinical trial. **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) ## Outcomes ### Primary outcomes 1. Occurrences of Streptococcus pneumoniae in the nasopharynx Timeframe: 3, 6, 9 and 15 months after second dosing, if healthy, and 14 days through 15 months after second dosing at the time of AOM, LRTI, and/or URTI episodes Occurrence of a culture-confirmed S. pneumoniae of differing serotypes in the nasopharynx (as defined by isolation of S. pneumoniae from NP samples) \* at four healthy visits, child age 12, 15, 18 and 24 months old and/or \* 14 days after second vaccine dose through 24 months of age, at AOM, LRTI, and URTI visits throughout study participation. ### Secondary outcomes 1. Occurrence of new serotype of Streptococcus pneumoniae in the nasopharynx during viral upper respiratory infection at onset of acute otitis media Timeframe: between 14 days after the second dose of vaccine and 24 months of age Occurrence of a culture-confirmed new serotype of S. pneumoniae in the nasopharynx during viral URI at onset of AOM (as defined by isolation of S. pneumonia of differing serotypes from NP samples) between 14 days after the second dose of vaccine and 24 months of age Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) ## Eligibility **Sex** All **Age groups** Children **Minimum age** 5 Months **Maximum age** 7 Months **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) ## Sites - Pittsford PediatricsPittsford, United StatesRecruiting - Western New York Geneva PediatricsRochester, United StatesActive, not recruiting - Bay Creek PediatricsRochester, United StatesActive, not recruiting - Long Pond PediatricsRochester, United StatesRecruiting - Rochester Medical Group General Pediatric AssociatesRochester, United StatesActive, not recruiting - Westside Pediatric GroupRochester, United StatesRecruiting - Panorama PediatricsRochester, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) ## References ### Other registry identifiers - 1U01AI172733-01A1 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07216430) ## Related records ### Drugs (1) - [Sodium chloride](https://trialight.com/data/asset/sodium-chloride-a67c33bc-45ef-42e4-8022-d121f0a86585.md) ### Collaborators (4) - Alira Health - National Institute of Allergy and Infectious Diseases (NIAID) - Rochester General Hospital - [Serum Institute of India Pvt. Ltd.](https://trialight.com/data/company/serum-institute-of-india-pvt-ltd-83f1638e-64f7-4ee9-9ca0-7ae346be8b28.md) ### Lead sponsors (1) - [Serum Life Science Europe GmbH](https://trialight.com/data/company/serum-life-science-europe-gmbh-16fe2b54-fac4-4d2d-b514-9fdd9bff9a3e.md) ### Conditions (2) - [Infectious otitis media](https://trialight.com/data/condition/infectious-otitis-media-f40bd52c-06fc-5246-993c-86e35f6a6c07.md) Primary condition - [Otitis media](https://trialight.com/data/condition/otitis-media-aa1c6944-b9f6-58dc-8e64-6624ba1f0d76.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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