Data Sources and Study Population
Cross-source consensus on Data Sources and Study Population from 1 sources and 5 claims.
1 sources · 5 claims
Where it comes from
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Highlighted claims
- The study uses administrative claims and electronic health record data from five US research partners in FDA's Sentinel System. — 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
- Eligible individuals are adults aged 50 years and older with evidence of one adjuvanted RSVPreF3 dose between August 1, 2023 and June 30, 2030. — 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 participating partners contribute longitudinal healthcare encounter data for about 17 million privately insured adults aged 50 years and older. — 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
- Vaccination will be identified using National Drug Codes, CPT code 90679, or CVX 303. — 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
- Patient-level data remain behind institutional firewalls while analytic datasets are returned to the coordinating center. — 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