Kawasaki disease and immunisation: A systematic review

Phuong, Linny Kimly; Bonetto, Caterina; Buttery, Jim; Pernus, Yolanda Brauchli; Chandler, Rebecca; Felicetti, Patrizia; Goldenthal, Karen L.; Kuçuku, Merita; Monaco, Giuseppe; Pahud, Barbara; Shulman, Stanford T.; Top, Karina A; Trotta, Francesco; Ulloa‐Gutiérrez, Rolando; Varricchio, Frederick; Ferranti, Sarah D. de; Dahdah, Nagib; Singh, Surjit; Bonhoeffer, Jan; Burgner, David

doi:10.1016/j.vaccine.2016.09.033

Cited by 27 publications

(31 citation statements)

References 72 publications

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“…While the investigator reported this event as "unassessable/unclassifiable" in association with the study vaccine administration (and this infant also received vaccination against rotavirus infection with a pentavalent vaccine), it should be recognized that no clear causal association between vaccination with DTaP-IPV (or any other vaccine) and Kawasaki disease has been found. 21,22 Furthermore Korea has the second highest…”

Section: Discussionmentioning

confidence: 99%

Post-marketing surveillance to assess the safety and tolerability of a combined diphtheria, tetanus, acellular pertussis and inactivated poliovirus vaccine (DTaP-IPV) in Korean children

Lee

Kim²,

Chen³

et al. 2019

Human Vaccines & Immunotherapeutics

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Infanrix-IPV (GSK, Belgium) is a diphtheria, tetanus, acellular pertussis, and inactivated poliovirus combination vaccine (DTaP-IPV) licensed in many countries including Korea. In accordance with Korean regulations, we conducted a post-marketing surveillance (PMS) to evaluate the safety of DTaP-IPV administered to Korean children in routine immunization schedules. Children aged <7 years receiving at least one dose of DTaP-IPV either as part of a primary (3-dose) vaccination series or as a subsequent booster were enrolled. Adverse events (AEs), adverse drug reactions (ADRs) and serious AEs (SAEs) were recorded after each dose during the 30-day post-vaccination follow-up period. Among a total of 639 children, 289 subjects (45.2%) experienced AEs, mostly (79.2%) assessed as being unlikely to be related to the vaccination. ADRs were reported in 13.0% of subjects. Fever was the most commonly reported expected AE (11.9% of subjects) and also the most commonly reported expected ADR (8.5% of subjects). No obvious association between AE incidence and vaccine dose sequence was apparent. An unexpected AE was seen in 32.9% of children, and unexpected ADRs were far less common (1.9%). Thirty-four SAEs were recorded in 26 subjects (4.1%), in two of whom a causal association with the vaccine could not be excluded, although both resolved quickly. Data from this PMS indicate that DTaP-IPV has an acceptable safety profile when given to Korean children in accordance with local prescribing recommendations in routine childhood immunization. ClinicalTrials.gov identifier: NCT01568060 ARTICLE HISTORY

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Section: Discussionmentioning

confidence: 99%

Post-marketing surveillance to assess the safety and tolerability of a combined diphtheria, tetanus, acellular pertussis and inactivated poliovirus vaccine (DTaP-IPV) in Korean children

Lee

Kim²,

Chen³

et al. 2019

Human Vaccines & Immunotherapeutics

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“…KD and MS were defined based on International Classification of Diseases (ICD-10) diagnostic codes in administrative data. We were not able to separate KD cases into definite, probable and possible KD in the manner of the Brighton Collaboration [17]. See S1 Table for ICD-10 codes used for each medical condition.…”

Section: Methodsmentioning

confidence: 99%

“…KD has been consistently reported in passive paediatric AEFI surveillance [1,13,14]. Given the proposed role of an immunologic response in the unknown etiology of this acquired systemic childhood vasculitis, immunization has been questioned as a possible cause [15,16], but a recent systematic review found no association between KD and immunization [17]. Of note, active hospital-based surveillance of KD in Ontario has shown that the incidence of KD in Ontario may be one of the highest outside of Asia [18].…”

Section: Introductionmentioning

confidence: 99%

Demonstration of background rates of three conditions of interest for vaccine safety surveillance

et al. 2019

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IntroductionAdverse events following immunization (AEFIs) are unwanted or unexpected health outcomes following vaccination, which may or may not be causally-linked to vaccines. AEFI reporting is important to post-marketing vaccine safety surveillance and has the potential to identify new or rare AEFIs, show increases in known AEFIs, and help to maintain public confidence in vaccine programs. Knowledge of the expected incidence (i.e. background rate) of a possible AEFI is essential to the investigation of vaccine safety signals. We selected three rarely reported AEFIs representing the spectrum of causal association with vaccines, from proven (immune thrombocytopenia [ITP]) to questioned (Kawasaki disease [KD]) to unsubstantiated (multiple sclerosis [MS]) and determined their background rates.MethodsWe extracted data on hospitalizations (CIHI Discharge Abstract Database) for ITP, KD, and MS among Ontario children for the period 2005 to 2014 from IntelliHEALTH. As ITP can be managed without hospitalization, we also extracted emergency department (ED) visits from the CIHI National Ambulatory Care Reporting System. For all conditions, we only counted the first visit and if the same child had both an ED visit and a hospitalization for ITP, only the hospitalization was included. We calculated rates by year, age group and sex using population estimates from 2005–2014, focusing on age groups within the Ontario immunization schedule around vaccine(s) of interest.ResultsPer 100,000 population, annual age-specific incidence of ITP in children age 1 to 7 years ranged from 8.9 to 12.2 and annual incidence of KD in children less than 5 years ranged from 19.1 to 32.1. Average annualized incidence of adolescent (11–17 years) MS across the study period was 0.8 per 100,000.DiscussionDespite limitations, including lack of clinical validation, this study provides an example of how health administrative data can be used to determine background rates which may assist with interpretation of passive vaccine safety surveillance.

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“…Using the SCCS method, we found no evidence of an increased risk of KD after PCV (7-or 13-valent) or MenB vaccine. This is reassuring, given the potential signals for PCV from earlier studies (7) and anecdotal reports of cases occurring following MenB vaccination (6).…”

Section: Discussionmentioning

confidence: 62%

“…Individual cases of KD have been reported following childhood vaccination (3)(4)(5), including with the pneumococcal conjugate vaccine (PCV) and meningococcal serogroup B vaccine (4CMenB™, also known as Bexsero™) (6).A post-licensure safety study of the 13-valent PCV (PCV13) using the Vaccine Safety Datalink network in the United States (US) suggested a possible elevated risk of KD after PCV13 when compared with the 7-valent PCV (PCV7) (7). However, no elevated risk after PCV13 was found in a subsequent study using an alternative US linked dataset (8).…”

Section: Introductionmentioning

confidence: 99%

The risk of Kawasaki disease after pneumococcal conjugate & meningococcal B vaccine in England: A self-controlled case-series analysis

Stowe

Andrews

Turner

et al. 2020

Vaccine

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Kawasaki disease and immunisation: A systematic review

Cited by 27 publications

References 72 publications

Post-marketing surveillance to assess the safety and tolerability of a combined diphtheria, tetanus, acellular pertussis and inactivated poliovirus vaccine (DTaP-IPV) in Korean children

Post-marketing surveillance to assess the safety and tolerability of a combined diphtheria, tetanus, acellular pertussis and inactivated poliovirus vaccine (DTaP-IPV) in Korean children

Demonstration of background rates of three conditions of interest for vaccine safety surveillance

The risk of Kawasaki disease after pneumococcal conjugate & meningococcal B vaccine in England: A self-controlled case-series analysis

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