Safety monitoring of mpox vaccines using cohort event monitoring: a WHO protocol

Overview

On the front page also: Protocol identifying number: ERC.0004184. Use of this protocol: As a master protocol to be approved by WHO Ethical Review Committee (‎ERC)‎, study sites will submit this protocol to national ERCs with amendments including the names of the national principal investigators (‎PIs)‎ and research teams and study sites. Only changes that would be made on a country-specific basis would be those to facilitate translation into the local language, address the specific concerns of local ERCs, and adding local study facility sites and study teams. Amended site-specific protocols developed for implementation in countries under this WHO master protocol will be submitted for review and approval to the WHO ERC prior to implementation."