Safety and Efficacy of wSp Vaccine in Young Children

Conditions

• Acute Otitis Media (AOM)

Eligibility Criteria

Sex

ALL

Age

5 Months - 7 Months

Healthy Volunteers

Accepted

Interventions

• wSp vaccine — BIOLOGICAL
  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 Details

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.

Key Dates

Start date

Sep 29, 2025

Status verified

May 2026

Primary completion

Jun 30, 2028

Completion

Jun 30, 2029

Study Design

Enrollment

320 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: 2x 1 mg wSp vaccine
  Intramuscular (IM) injections of 0.5 mL containing 1 mg of total protein
• Placebo Comparator: 2x 0.5 mL saline
  Intramuscular (IM) injections of 0.5 mL saline

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 ]

Central Contacts

• Marcus May, MD
  +49 511 16 99 08 0
  [email protected]

Locations (7)

Find similar trials in Pittsford, NY

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