Lack of Association of Kawasaki Disease After Immunization in a Cohort of Infants Followed for Multiple Autoimmune Diagnoses in a Large, Phase-4 Observational Database Safety Study of 7-Valent Pneumococcal Conjugate Vaccine

Center, Kimberly J.; Hansen, John; Lewis, Edwin; Fireman, Bruce; Hilton, Betsy

doi:10.1097/inf.0b013e318196934a

Cited by 20 publications

(9 citation statements)

References 9 publications

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“…For other PCVs, a largescale post-marketing study found that 42 7vCRM recipients and 17 children who received control vaccination were hospitalized for Kawasaki disease, but the difference between groups was not significant after adjusting for potential confounding variables [29]. Post-licensure surveillance following vaccination with the 13-valent CRM-conjugate vaccine (PCV13; Prevenar13/Prevnar13™, Pfizer Inc.) compared to 7vCRM found the relative risk for Kawasaki disease in the period up to 28 days after vaccination was 1.94 (95% CI: 0.79-4.86) [30].…”

Section: Kawasaki Diseasementioning

confidence: 99%

Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV)

Silfverdal

Coremans

François

et al. 2016

Expert Review of Vaccines

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Safety and reactogenicity data were reviewed following 10 years of experience with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in clinical development and from post-licensure settings. Analyses of pooled clinical trial data and post-marketing reports provided an overview of its safety profile and allowed assessment of rare adverse events that might not have been identified previously. The safety of PHiD-CV was also evaluated in children at higher risk for pneumococcal infection (preterm and HIV-infected or HIV-exposed infants), for different vaccination schedules and co-administered pediatric vaccines, and with a focus on special categories of adverse events (febrile convulsions, apnea, Kawasaki disease and sudden deaths). Following the distribution of over 235 million doses, PHiD-CV has been well tolerated when co-administered with other pediatric vaccines to children aged less than 5 years from diverse ethnic and geographic backgrounds. Detailed examination of various aspects has confirmed its favorable benefit: risk profile.

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Section: Kawasaki Diseasementioning

confidence: 99%

Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV)

Silfverdal

Coremans

François

et al. 2016

Expert Review of Vaccines

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“…Earlier studies such as the study by Center et al . did not specify the criteria used to define KD except that it was ‘pre-specified’ in collaboration with the FDA 6 . However, mean duration of fever was reported to be six days which may suggest that Incomplete KD cases were included.…”

Section: Discussionmentioning

confidence: 99%

“…A phase IV database analysis by Center et al . reported an increased risk of KD hospitalizations amongst recipients of PCV7 compared to historical controls (unadjusted RR 2.02 (95% CI, 1.16 to 3.63) 6 . However, after controlling for possible confounders including sex, race, age at first dose, etc., the RR of KD hospitalization was no longer statistically significantly (RR 1.67; 95% CI, 0.93 to 3.00) 6 .…”

Section: Introductionmentioning

confidence: 99%

Kawasaki Disease following administration of 13-valent pneumococcal conjugate vaccine in young children

Yung

Cheung

et al. 2019

Sci Rep

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Kawasaki disease (KD) is a systemic vasculitis mainly affecting young children and the leading cause of acquired heart disease in developed countries. We performed a self-controlled case series analysis to investigate the association between PCV13 and KD. All hospitalized KD cases <2 y old from our hospital in Singapore from 2010 to 2014 were included. Complete KD cases were classified based on the definitions of the American Heart Association. During the study period, 288 KD cases were identified. A total of 21 KD cases (12 were classified as Complete KD) had date of onset within the risk interval of day 1 to day 28 post PCV13. The age-adjusted Relative Incidence (RI) for KD following PCV13 dose 1, dose 2 and dose 3 were 1.40 (95%CI, 0.72 to 2.71), 1.23 (95% CI, 0.62 to 2.44) and 0.34 (95% CI, 0.08 to 1.40) respectively. There were seven Complete KD cases with onset during the risk interval after dose 1 of PCV13 (age-adjusted RI 2.59, 95%confidence interval (CI), 1.16 to 5.81). We did not detect a significant increased risk for overall KD among PCV13 recipients. However, a significant association between PCV13 and Complete KD was noted following receipt of the first dose of PCV13.

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“…The main characteristics of the papers are summarized in Supplemental Digital Content Table E2 . The number of published studies grew rapidly since 1999 with one third of the papers ( n = 23, 32.4%) being published within the last 2 years of the review.…”

Section: Resultsmentioning

confidence: 99%

Pharmacovigilance in children: detecting adverse drug reactions in routine electronic healthcare records. A systematic review

Black

Tagiyeva

Helms

et al. 2015

Brit J Clinical Pharma

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Aims A systematic review of the literature published in English over 10 years was undertaken in order to describe the use of electronic healthcare data in the identification of potential adverse drug reactions (ADRs) in children. Methods MEDLINE and EMBASE were searched using MESH headings and text words. Titles, keywords and abstracts were checked for age <18 years, potential ADRs and electronic healthcare data. Information extracted included age, data source, pharmacovigilance method, medicines and ADRs. Studies were quality assessed. Results From 14 804 titles, 314 had a full text review and 71 were included in the final review. Fifty were published in North America, 10 in Scandinavia. Study size ranged from less than 1000 children to more than 10 million. Sixty per cent of studies used data from one source. Comparative observational studies were most commonly reported (66.2%) with 15% using passive surveillance. Electronic healthcare data set linkage and the quality of the data source were poorly reported. ADRs were classified using the International Classification of Disease (ICD10). Multi‐system reactions were most commonly studied, followed by central nervous system and mental and behavioural disorders. Vaccines were most frequently prescribed followed by corticosteroids, general anaesthetics and antidepressants. Conclusions Routine electronic healthcare records were increasingly reported to be used for pharmacovigilance in children. This growing and important health protection activity could be enhanced by consistent reporting of studies to improve the identification, interpretation and generalizability of the evidence base.

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Lack of Association of Kawasaki Disease After Immunization in a Cohort of Infants Followed for Multiple Autoimmune Diagnoses in a Large, Phase-4 Observational Database Safety Study of 7-Valent Pneumococcal Conjugate Vaccine

Cited by 20 publications

References 9 publications

Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV)

Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV)

Kawasaki Disease following administration of 13-valent pneumococcal conjugate vaccine in young children

Pharmacovigilance in children: detecting adverse drug reactions in routine electronic healthcare records. A systematic review

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