Post-marketing study to assess the risk of intussusception after immunization with GlaxoSmithKline (GSK) Biologicals’ oral live-attenuated human rotavirus vaccine in infants less than 1 year old in Latin America (212329)

ENCePP Code of conduct

No information provided.

Data sources

• Data source(s):
  Other data source
• Data source(s), other:
  Medical records, parent(s)/legally acceptable representative (LAR[s]) interviews, vaccination cards and immunization registries.
• Data sources (types):
  Other

  Spontaneous reports of suspected adverse drug reactions

  Vaccination registry
• Data sources (types), other:
  Medical records

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

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

Data characterisation

• Data characterisation conducted:
  Yes

Procedures

No information provided.