Postmarketing Safety Surveillance
Cross-source consensus on Postmarketing Safety Surveillance from 1 sources and 4 claims.
1 sources · 4 claims
Uses
Other
Other
Other
Highlighted claims
- The protocol describes a non-interventional postauthorisation safety study in the United States for adjuvanted RSVPreF3. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study
- The study evaluates whether vaccination is associated with new-onset GBS, ADEM, and atrial fibrillation. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study
- At original licensure, FDA required active postmarketing surveillance for GBS and ADEM and requested AF monitoring as a postmarketing commitment. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study
- The study will share results with FDA and disseminate findings through scientific conferences and peer-reviewed publications. — Postmarketing safety surveillance for GSK’s AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study