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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07216430
- Acronym / sponsor ID
- wSp005 / wSp-US-2.03AOM
- Conditions
- Acute Otitis Media (AOM)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Serum Life Science Europe GmbHIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Rochester General Hospital, Serum Institute of India Pvt. Ltd., Alira Health
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 14 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2x 1 mg wSp vaccine | Experimental | Biological: wSp vaccineIntramuscular (IM) injections of 0.5 mL containing 1 mg of total protein |
| 2x 0.5 mL saline | Placebo comparator | Biological: Saline (0.9% NaCl)Intramuscular (IM) injections of 0.5 mL saline |
Who may qualify
- Ages
- 5 to 7 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wSp vaccineAlso: SPWCV, PATH-wSPwSp 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. | Biological | 2x 1 mg wSp vaccine |
| Saline (0.9% NaCl)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. | Biological | 2x 0.5 mL saline |
Primary outcome
Occurrences of Streptococcus pneumoniae in the nasopharynx
Time frame: 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.
1 secondary outcome
Occurrence of new serotype of Streptococcus pneumoniae in the nasopharynx during viral upper respiratory infection at onset of acute otitis media
Time frame: between 14 days after the second dose of vaccine and 24 months of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcus May, MD (+49 511 16 99 08 0, may@sls-eu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrences of Streptococcus pneumoniae in the nasopharynx (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.