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

Overview

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.

Full Title of Study: “A Study of V114 and Acute Otitis Media in Children (PNEU-ERA)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: June 5, 2025

Interventions

  • Biological: V114
    • IM injection
  • Other: Pediatric vaccines
    • Standard of care vaccines administered according to the local recommended schedule.

Arms, Groups and Cohorts

  • Experimental: V114
    • Participants will receive an intramuscular (IM) injection.
  • Other: Control

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants with a First Episode of Vaccine-Type Acute Otitis Media (VT-AOM) Caused by the Pneumococcal Serotypes Contained in V114
    • Time Frame: Up to ~36 months
    • The number of participants with VT-AOM will be presented.
  • Percentage of Participants with Serious Adverse Events
    • Time Frame: Up to ~36 months
    • A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.
  • Percentage of Participants with Vaccine-Related Serious Adverse Events
    • Time Frame: Up to ~36 months
    • A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.
  • Percentage of Participants Who Discontinued the Study due to Serious Adverse Events
    • Time Frame: Up to ~36 months
    • A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.
  • Percentage of Participants Who Died
    • Time Frame: Up to ~36 months
    • The percentage of participants who died from any cause during the study will be assessed.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 42 Days

Maximum Age: 90 Days

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Merck Sharp & Dohme LLC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Director, Study Director, Merck Sharp & Dohme LLC

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