Safety and Efficacy of wSp Vaccine in Young Children

PHASE2RecruitingINTERVENTIONAL
Enrollment

320

Participants

Timeline

Start Date

September 29, 2025

Primary Completion Date

June 30, 2028

Study Completion Date

June 30, 2029

Conditions
Acute Otitis Media (AOM)
Interventions
BIOLOGICAL

wSp 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 in the left thigh at 7 months of age, and dose 2 will be given in the right thigh at 9 months of age.

BIOLOGICAL

Saline (0.9% NaCl)

Saline will be administered as intramuscular (IM) injections of 0.5 mL. Dose 1 will be given in the left thigh at 7 months of age and dose 2 will be given in the right thigh at 9 months of age.

Trial Locations (4)

14456

RECRUITING

Western New York Geneva Pediatrics, Rochester

14580

RECRUITING

Bay Creek Pediatrics, Rochester

14621

RECRUITING

Rochester Medical Group General Pediatric Associates, Rochester

14625

RECRUITING

Panorama Pediatrics, Rochester

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

Rochester General Hospital

OTHER

collaborator

Serum Institute of India Pvt. Ltd.

INDUSTRY

collaborator

Alira Health

OTHER

lead

Serum Life Science Europe GmbH

INDUSTRY