A Post-Marketing Safety Study using a Pregnancy Registry to Evaluate the Safety of Respiratory Syncytial Virus Vaccine (ABRYSVO™) Exposure During Pregnancy (C3671041)

ENCePP Code of conduct

Yes

Data sources

• Data source(s), other:
  This study will use data collected as part of the CorEvitas RSV Vaccine Pregnancy Registry (RSV-PR). ; The RSV-PR will collect data from participants and the health care providers involved in their care or the care of their infants via concise data collection forms at pre-defined timepoints during pregnancy, at pregnancy outcome, and up to 1 year of infant age.
• Data sources (types):
  Pregnancy registry

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

• Check conformance:
  Unknown
• Check completeness:
  Unknown
• Check stability:
  Unknown
• Check logical consistency:
  Unknown

Data characterisation

• Data characterisation conducted:
  Unknown

Procedures

No information provided.