Acute intussusception in infants and children as an adverse event following immunization: case definition and guidelines of data collection, analysis, and presentation

Bines, Julie E; Kohl, Katrin; Förster, Johannes; Zanardi, L; Davis, Robert L.; Hansen, John; Murphy, Trudy M; Music, Stanley; Niu, Mannette; Varricchio, Frederick; Vermeer, Patricia; Wong, Emily J.

doi:10.1016/j.vaccine.2003.09.016

Cited by 212 publications

(159 citation statements)

References 3 publications

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“…These case questionnaires were sent to the principal investigator of the study (A.N. ), and each case was ascertained according to the diagnostic certainty defined by the Brighton Collaboration Intussusception Working Group (19).…”

Section: Materilas and Methodsmentioning

confidence: 99%

Incidence of Intussusception as Studied from a Hospital-Based Retrospective Survey over a 10-Year Period (2001^|^ndash;2010) in Akita Prefecture, Japan

et al. 2012

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SUMMARY:One concern about rotavirus vaccines is its possible association with intussusception. Thus, it is necessary to determine the baseline incidence for intussusception in the first year of life in places where rotavirus vaccines are introduced. However, few safety data exist for the period at which the first dose of Rotarix and RotaTeq are allowed to administer in Japan. The first dose of Rotarix is scheduled to administer at 6-20 weeks of age and that of RotaTeq is scheduled to administer at 6-24 weeks of age; the upper limits for these vaccines is later than the upper limit recommended by the World Health Organization by 5 and 9 weeks, respectively. We performed a retrospective cross-sectional study by reviewing medical charts of all hospitals that provided pediatric beds in Akita Prefecture, Japan, and identifying the cases of intussusception that met the Brighton criteria level 1 in these hospitals between January 2001 and December 2010. During this 10-year period, 122 children younger than 1 year of age were diagnosed with intussusception. The incidence of intussusception was estimated at 158 per 100,000 person-years among children younger than 1 year (95z confidence interval, 131-188), 10 per 100,000 person-years for children aged 0-2 months, 165 for children aged 3-5 months, and 300 for children aged 6-8 months. This rapid and substantial increase in the incidence of intussusception during the first year of life should be considered when formulating the immunization schedule for administering rotavirus vaccines in Japan.

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Section: Materilas and Methodsmentioning

confidence: 99%

Incidence of Intussusception as Studied from a Hospital-Based Retrospective Survey over a 10-Year Period (2001^|^ndash;2010) in Akita Prefecture, Japan

et al. 2012

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“…The inclusion criteria were defined before the start of the study on the basis of the PICO framework (patient group, intervention, control group, outcome): (24). Only studies with a SCCS design were included in the systematic review; this design was developed for the investigation of rare events (details of the study design are given in eBox 1) (25).…”

Section: Selection Of Studiesmentioning

confidence: 99%

“…The mean observation period was 4.7 years (median: 5.0 years; range: 1.5-7.5 years). In 7 of the 10 studies, the intussusception diagnoses in the cases included met the level 1 Brighton criteria (24). Six studies showed a low and 4 a moderate risk of bias (for details see the eTable).…”

Section: Study Characteristicsmentioning

confidence: 99%

Risk of Intussusception After Rotavirus Vaccination

Koch¹,

Harder²,

Kries³

et al. 2017

Deutsches Ärzteblatt International

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SUMMARYBackground: In 2013, the German Standing Committee on Vaccination (Stän-dige Impfkommission, STIKO) recommended rotavirus (RV) vaccination for all infants while stating that this mildly increased the risk of intussusception, a potentially life-threatening event. Since this recommendation was issued, multiple observational studies on this topic designed as self-controlled case series (SCCS) have been published. The SCCS design is particularly suitable for the study of rare adverse effects of medications.

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“…In this analysis, intussusception events were considered confirmed if they met the Level 1 criteria included in the Brighton Collaboration case definition. 16 Onset date of intussusception was defined as the day of symptom onset. We compared the onset interval of intussusception reports after RV5 dose1 reports with all RV5 dose 1 nonintussusception reports for the same age group, to illustrate the difference in reporting.…”

Section: Data Sourcesmentioning

confidence: 99%

Intussusception After Rotavirus Vaccines Reported to US VAERS, 2006–2012

et al. 2013

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BACKGROUND: In 2006 and 2008, 2 new rotavirus vaccines (RotaTeq [RV5] and Rotarix [RV1]) were introduced in the United States. METHODS: We assessed intussusception events reported to the Vaccine Adverse Event Reporting System from February 2006 through April 2012 for RV5 and from April 2008 through April 2012 for RV1. For RV5, we conducted a self-controlled risk interval analysis using Poisson regression to estimate the daily reporting ratio (DRR) of intussusception comparing average daily reports 3 to 6 versus 0 to 2 days after vaccination. We calculated reporting rate differences based on DRRs and background rates of intussusception. Sensitivity analyses were conducted to assess effects of differential reporting completeness and inaccuracy of baseline rates. Few reports were submitted after RV1, allowing only a descriptive analysis. RESULTS: The Vaccine Adverse Event Reporting System received 584 confirmed intussusception reports after RV5 and 52 after RV1, with clustering 3 to 6 days after both vaccines. The DRR comparing the 3- to 6-day and the 0- to 2-day periods after RV5 dose 1 was 3.75 (95% confidence interval = 1.90 to 7.39). There was no significant increase in reporting after dose 2 or dose 3. Over all 3 doses, the excess risk of intussusception was 0.79 events (95% confidence interval = –0.04 to 1.62) per 100 000 vaccinations. From the sensitivity analyses, we conclude that under a worst-case scenario, the DRR could be 5.00 and excess risk per 100 000 doses could be 1.36. CONCLUSIONS: We observed a persistent clustering of reported intussusception events 3 to 6 days after the first dose of RV5 vaccination. This clustering could translate to a small increased risk of intussusception, which is outweighed by the benefits of rotavirus vaccination.

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Acute intussusception in infants and children as an adverse event following immunization: case definition and guidelines of data collection, analysis, and presentation

Cited by 212 publications

References 3 publications

Incidence of Intussusception as Studied from a Hospital-Based Retrospective Survey over a 10-Year Period (2001^|^ndash;2010) in Akita Prefecture, Japan

Incidence of Intussusception as Studied from a Hospital-Based Retrospective Survey over a 10-Year Period (2001^|^ndash;2010) in Akita Prefecture, Japan

Risk of Intussusception After Rotavirus Vaccination

Intussusception After Rotavirus Vaccines Reported to US VAERS, 2006–2012

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