V114 and Acute Otitis Media (V114-032/PNEU-ERA)

Merck Sharp & Dohme (MSD)

Status and phase: Active, not recruiting; Phase 3

Conditions: Acute Otitis Media (AOM)

Treatments: Biological: V114; Other: Pediatric vaccines

Study type: Interventional

Funder types: Industry

Identifiers

NCT04193215

2023-001146-11 (EudraCT Number)

V114-032 (Other Identifier)

Details and patient eligibility

About

The primary objective is to evaluate V114 in the prevention of vaccine-type acute otitis media (VT-AOM) and the safety of V114 with respect to the proportion of participants with serious adverse events (SAEs) through completion of the study. The primary hypothesis is that V114 is superior to no V114 in preventing VT-AOM as assessed by the incidence of VT-AOM.

Enrollment: 7,000 estimated patients

Sex: All

Ages: 42 to 90 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Is healthy (based on a review of medical history and physical examination)
• Is male or female, approximately 2 months of age, from 42 days to 90 days of age

Exclusion criteria

• Was born prior to 37 weeks of gestation.
• Has a history of invasive pneumococcal disease (IPD) (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
• Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid-containing vaccine.
• Has any contraindication to the concomitant study vaccines being administered in the study.
• Has external auditory canal atresia/stenosis.
• Has a known or suspected impairment of immunological function.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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7,000 participants in 2 patient groups

V114

Experimental group

Description:

Participants will receive an intramuscular (IM) injection.

Treatment:

Other: Pediatric vaccines

Biological: V114

Control

Other group

Treatment:

Other: Pediatric vaccines