Abstract
Intussusception is a rare, potentially life-threatening condition in early childhood. It gained attention due to an unexpected association with the first rotavirus vaccine, RotaShield, which was subsequently withdrawn from the market. Across Europe, broad variations in intussusception incidence rates have been reported. This study provides a first estimate of intussusception incidence in young children in the Netherlands from 1 January 2008 to 31 December 2012, which could be used for future rotavirus safety monitoring. Our estimates are based on two different sources: electronic medical records from the primary healthcare database (IPCI), as well as administrative data from the Dutch hospital register (LBZ). The results from our study indicate a low rate of intussusception. Overall incidence rate in children < 36 months of age was 21.2 per 100,000 person-years (95% confidence interval (CI): 12.5–34.3) based on primary healthcare data and 22.6 per 100,000 person-years (95% CI: 20.9–24.4) based on hospital administrative data. The estimates suggest the upper and lower bound of the expected number of cases.
Highlights
Rotavirus infections are a leading cause of severe diarrhoeal illness in infants and young children [1]
In the Landelijke Basisregistratie Ziekenhuiszorg (LBZ) database, 705 potential cases of intussusception were identified during the study period and 166 duplicate cases were excluded
The intussusception incidence rate in children < 12 months of age is 27.9 per 100,000 person-years based on cases from the primary healthcare data that were validated, and 35.0 per 100,000 person-years based on the non-validated hospital data
Summary
Rotavirus infections are a leading cause of severe diarrhoeal illness in infants and young children [1]. As demonstrated by a number of studies, rotavirus vaccines are effective in preventing severe diarrhoeal illness caused by certain rotavirus serotypes [2,3]. In 1999 the first rotavirus vaccine, RotaShield (Wyeth Laboratories, Inc., Pennsylvania, United States), was voluntarily withdrawn from the market due to an unexpected association with intussusception [4]. In 2009, the World Health Organization Strategic Advisory Group of Experts (SAGE) recommended the use of rotavirus vaccines in all national immunisation programs, and by 2016, 11 countries of the European Union had included rotavirus vaccination in their national vaccination programme [5]. Large-scale pre-licensure clinical trials did not identify an increased risk for intussusception, post-licensure data suggested a small increase in risk of intussusception that was closely linked to the age of vaccination after rotavirus vaccination with both licensed vaccines [6,7,8,9,10,11]
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