Acute Otitis Media (AOM)Phase 2wSp005NCT07216430
Safety and Efficacy of wSp Vaccine in Young Children
A Phase 2 study testing wSp vaccine and Saline (0.9% NaCl) in people with Acute Otitis Media (AOM), run by Serum Life Science Europe GmbH at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 7 monthsHealthy volunteers can take part
- Conditions the study is for
- Acute Otitis Media (AOM)
- What is being tested?
- wSp vaccine and Saline (0.9% NaCl)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 7 sitesUnited States
- Study dates
- 29 Sep 2025to Jun 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 7 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 4 recruiting
- Recruiting
Pittsford Pediatrics
Pittsford, New York, 14534
Rahul Sengupta, 585-385-1710, rsendr.d@gmail.com
- Active, not recruiting
Western New York Geneva Pediatrics
Rochester, New York, 14456
- Active, not recruiting
Bay Creek Pediatrics
Rochester, New York, 14580
- Recruiting
Long Pond Pediatrics
Rochester, New York, 14606
Tracy Wright, 585-225-0950, tracyarora79@gmail.com
- Active, not recruiting
Rochester Medical Group General Pediatric Associates
Rochester, New York, 14621
- Recruiting
Westside Pediatric Group
Rochester, New York, 14624
David Sayre, 585-247-5400, dsayre59@gmail.com
- Recruiting
Panorama Pediatrics
Rochester, New York, 14625
Kim Vogelsang, 585-381-4848, KVogelsang@panoramapeds.com
About this study
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.
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:
Read more
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.
- Conditions
- Acute Otitis Media (AOM)
- Being tested
- wSp vaccine, Saline (0.9% NaCl)
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wSp vaccineBiological
Also called SPWCV, PATH-wSP
wSp vaccine will be administered as intramuscular (IM) injections of 0.5 mL (thus 1 mg total protein). wSp vaccine is supplied as single-dose glass vials in saline (0.9% sodium chloride) at 2 mg protein/mL, with aluminum hydroxide at 1.2 mg elemental Al/mL. Dose 1 will be given preferably in the left thigh at approximately 7 months of age, and dose 2 will be given preferably in the right thigh at approximately 9 months of age.
Saline (0.9% NaCl)Biological
Saline will be administered as intramuscular (IM) injections of 0.5 mL. Dose 1 will be given preferably in the left thigh at approximately 7 months of age and dose 2 will be given preferably in the right thigh at approximately 9 months of age.
| Study group | Role | What they receive |
|---|---|---|
| 2x 1 mg wSp vaccine | Experimental | Intramuscular (IM) injections of 0.5 mL containing 1 mg of total protein Receives: Biological: wSp vaccine |
| 2x 0.5 mL saline | Placebo comparator | Intramuscular (IM) injections of 0.5 mL saline Receives: Biological: Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrences of Streptococcus pneumoniae in the nasopharynx
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.
Measured: 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
Secondary outcomes (1)
Occurrence of new serotype of Streptococcus pneumoniae in the nasopharynx during viral upper respiratory infection at onset of acute otitis media
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
Measured: between 14 days after the second dose of vaccine and 24 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start29 Sep 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Otitis Media (AOM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Serum Life Science Europe GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Rochester General Hospital, Serum Institute of India Pvt. Ltd., Alira Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216430
- Sponsor's protocol ID
- wSp-US-2.03AOM
- Other IDs
- 1U01AI172733-01A1
- Acronym
- wSp005
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No