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

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.

Timeline

Start

2020-09-12

Primary completion

2025-12-22

Completion

2025-12-22

Drugs

Indications