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

NCT04193215 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7119

Last updated 2026-01-22

No results posted yet for this study

Summary

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.

Conditions

  • Acute Otitis Media (AOM)

Interventions

BIOLOGICAL

V114

IM injection

OTHER

Pediatric vaccines

Standard of care vaccines administered according to the local recommended schedule.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
42 Days
Max Age
90 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-12
Primary Completion
2025-12-22
Completion
2025-12-22
FDA Drug
Yes

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04193215 on ClinicalTrials.gov