Spatio-temporal impact of Rotavirus vaccine coverage on Rotavirus Hospitalizations in the Valencia Region, Spain

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study

Non-interventional study

• Scope of the study:
  Effectiveness study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Post-licensure vaccine impact study
• Data collection methods:
  Secondary data collection
• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective, population-based study

Study drug and medical condition

• Medical condition to be studied:
  Rotavirus infection

Population studied

• Short description of the study population:
  Valencia Region’s children less than 3 years during the study period.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)
• Estimated number of subjects:
  721741

Study design details

• Main study objective:
  - To estimate spatio-temporal impact of rotavirus vaccine coverage on rotavirus acute gastroenteritis hospitalizations among Valencia Region´s population aged less than 3 years.- To assess space-time variation in hospitalized acute rotavirus gastroenteritis risk.- To assess space-time variation in r
• Outcomes:
  - Rotavirus acute gastroenteritis hospitalization: hospitalization with a discharge diagnosis of enteritis due to rotavirus (ICD-9-CM code 008.61) in any diagnosis position. - Acute gastroenteritis hospitalization: hospitalization with a discharge diagnosis of gastroenteritis-associated episode (ICD-9-CM codes 001-009, 558.9, 787.91) in any diagnosis position.
• Data analysis plan:
  We evaluate the spatio-temporal impact of vaccination on rotavirus hospitalization rates (response variable) by a Bayesian spatio-temporal logistic regression contemplating gender, age, health department, bi-annual periods and health care district.To evaluate the space-time behavior of rotavirus/ hospitalization rates and vaccine coverage, we model by the Besag-York-Mollié model the following smoothed risk estimates: the standardized hospitalization ratio and the standardized vaccination rate, considering bi-annual periods and health care districts.

Documents

Results tables

reportFV