Acute Otitis Media (AOM)
Conditions
Brief 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.
Interventions
BIOLOGICALwSp vaccine
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.
BIOLOGICALSaline (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.
Sponsors
Serum Life Science Europe GmbH
National Institute of Allergy and Infectious Diseases (NIAID)
Rochester General Hospital
Serum Institute of India Pvt. Ltd.
Alira Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
5 Months to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrences of Streptococcus pneumoniae in the nasopharynx | 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
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of new serotype of Streptococcus pneumoniae in the nasopharynx during viral upper respiratory infection at onset of acute otitis media | 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 |
Countries
United States
Contacts
CONTACTMarcus May, MD
Outcome results
None listed