Impact of Rotavirus Vaccination on Acute Gastroenteritis outpatient and emergency department visits using “Real World Data” from the Valencia Region, Spain

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Post-licensure vaccination impact study

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational retrospective study

Study drug and medical condition

• Medical condition to be studied:
  Gastroenteritis rotavirus

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Children (2 to < 12 years)
• Estimated number of subjects:
  600000

Study design details

• Main study objective:
  To estimate the impact of rotavirus vaccination on all-cause acute gastroenteritis outpatient (AGE-O) and Emergency Department (AGE-ED) consultations among children aged less than 5 years from the Valencia Region.
• Outcomes:
  1- AGE-O: all-cause acute gastroenteritis outpatients visits. 2- AGE-ED: all-cause acute gastroenteritis emergency department visits. 3- AGE-O or AGE-ED: all-cause acute gastroenteritis outpatient and emergency department visits.
• Data analysis plan:
  A descriptive analysis will be developed, yearly outpatients and ED rates will be calculated as the number of AGE-O or AGE-ED visits divided by the total population by gender, age, health department and in general.