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Objective: To provide insights into complexities of seeking access to state and federal cross-jurisdictional data for linkage with the Australian Childhood Immunisation Register (ACIR). We provide recommendations for improving access and receipt of linked datasets involving Australian Government-administered data., Methods: We describe requirements for linking eleven federal and state data sources to establish a national linked dataset for safety evaluation of vaccines. The required data linkage methodology for integrating cross-jurisdictional data sources is also described., Results: Extensive negotiation was required with 18 different agencies for 21 separate authorisations and 12 ethics approvals. Three variations of the 'best practice' linkage model were implemented. Australian Government approval requests spanned nearly four years from initial request for data, with a further year before ACIR data transfer to the linkage agency., Conclusions: Integration of immunisation registers with other data collections is achievable in Australia but infeasible for routine and rapid identification of vaccine safety concerns. Lengthy authorisation requirements, convoluted disparate application processes and inconsistencies in data supplied all contribute to delayed data availability. Implications for public health: Delayed data access for safety surveillance prevents timely epidemiological reviews. Poor responsiveness to safety concerns may erode public confidence, compromising effectiveness of vaccination programs through reduced participation., (© 2019 The Authors.)

Background: A hypotonic hyporesponsive episode (HHE) is a well-described adverse event following immunisation (AEFI) in young children. There is limited data regarding recurrence post re-vaccination., Method: A retrospective analysis of HHEs reported to two tertiary paediatric hospitals in Australia: The Royal Children's Hospital, Melbourne [2006-11] and the Children's Hospital Westmead, Sydney [1997-2014]. HHE definition level of confidence was allocated according to Brighton Collaboration (BC) criteria and defined immediate if within 30 min post vaccination. The Australian Immunisation Register (AIR) was utilised to document current immunisation status., Results: 235 HHE cases (135 Melbourne, 100 Sydney) were identified: 47% were female and 67% (157/235) occurred following the routine dose one vaccines at 6-8 weeks of age. Median time following immunisation was 120 min (range 1 min to 14 days) An immediate HHE occurred in 43% (102/235) and by BC criteria, 74% (173/235) were level 1 (definite). Subsequent vaccines were administered under supervision in hospital in 37% overall (86/235); 43% (58/135) in Melbourne and 28% (28/100) in Sydney. HHE recurrence rate was 3% (7/235) [95% confidence interval 1-6%]. AIR records were available in 94% (221/235). At a median age of 3.1 years, 84% (186/221) were up-to-date with recommended vaccines., Conclusion: This study highlights the importance of specialist immunization clinics in supporting the National Immunisation Program, through follow-up and management of serious adverse events following immunization., (Crown Copyright © 2018. Published by Elsevier Ltd. All rights reserved.)

Background: Kawasaki disease is a complex and potentially serious condition. It has been observed in temporal relation to immunisation., Methods: We conducted a systematic literature review using various reference sources to review the available evidence published in the literature., Results: We identified twenty seven publications reporting a temporal association between immunisation and Kawasaki disease. We present a systematic review of data drawn from randomised controlled trials, observational studies, case series and reports, and reviews. Overall there was a lack of standardised case definitions, making data interpretation and comparability challenging., Conclusions: Although a temporal relationship between immunisation and Kawasaki disease is suggested, evidence for an increased risk or a causal association is lacking. Implementation of a standardised Kawasaki disease case definition would increase confidence in the findings and add value to future studies of pre- or post-licensure vaccine safety studies., (Copyright © 2016. Published by Elsevier Ltd.)

Immunization in pregnancy provides a promising contribution to globally reducing neonatal and under-five childhood mortality and morbidity. Thorough assessment of benefits and risks for the primarily healthy pregnant women and their unborn babies is required. The GAIA project was formed in response to the call of the World Health Organization for a globally concerted approach to actively monitor the safety of vaccines and immunization in pregnancy programs. GAIA aims to improve the quality of outcome data from clinical vaccine trials in pregnant women with a specific focus on the needs and requirements for safety monitoring in LMIC. In the first year of the project, a large and functional network of experts was created. The first outputs include a guidance document for clinical trials of immunization in pregnancy, a basic data collection guide, ten case definitions of key obstetric and neonatal health outcomes, an ontology of key terms and a map of pertinent disease codes. The GAIA Network is designed as an open and growing forum for professionals sharing the GAIA vision and aim. Based on the initial achievements, tools and services are developed to support investigators and strengthen immunization in pregnancy programs with specific focus on LMIC., (Copyright © 2016. Published by Elsevier Ltd.)

Maternal vaccination is an important area of research and requires appropriate and internationally comparable definitions and safety standards. The GAIA group, part of the Brighton Collaboration was created with the mandate of proposing standardised definitions applicable to maternal vaccine research. This study proposes international definitions for neonatal infections. The neonatal infections GAIA working group performed a literature review using Medline, EMBASE and the Cochrane collaboration and collected definitions in use in neonatal and public health networks. The common criteria derived from the extensive search formed the basis for a consensus process that resulted in three separate definitions for neonatal blood stream infections (BSI), meningitis and lower respiratory tract infections (LRTI). For each definition three levels of evidence are proposed to ensure the applicability of the definitions to different settings. Recommendations about data collection, analysis and presentation are presented and harmonized with the Brighton Collaboration and GAIA format and other existing international standards for study reporting., (Copyright © 2016. Published by Elsevier Ltd.)

Preterm birth is commonly defined as any birth before 37 weeks completed weeks of gestation. An estimated 15 million infants are born preterm globally, disproportionately affecting low and middle income countries (LMIC). It contributes directly to estimated one million neonatal deaths annually and is a significant contributor to childhood morbidity. However, in many clinical settings, the information available to calculate completed weeks of gestation varies widely. Accurate dating of the last menstrual period (LMP), as well as access to clinical and ultrasonographic evaluation are important components of gestational age assessment antenatally. This case definition assign levels of confidence to categorisation of births as preterm, utilising assessment modalities which may be available across different settings. These are designed to enable systematic safety evaluation of vaccine clinical trials and post-implementation programmes of immunisations in pregnancy., (Copyright © 2016. Published by Elsevier Ltd.)

Background: Meningococcal C conjugate (Men C) vaccines have been routinely used in the UK since November, 1999. Little information exists regarding antibody persistence or immunologic memory after infant vaccination or response to a first dose at 4 years., Methods: Ninety-five children immunized at 2, 3 and 4 months of age with 0 or 3 doses of Men C vaccine, boosted with Men C or meningococcal A/C polysaccharide vaccine at 12 months, received a single dose of Men C vaccine at 4 years; 103 age-matched controls were recruited. Pre- and postvaccination Men C IgG (enzyme-linked immunosorbent assay) antibody titers and serum bactericidal activity (SBA) were measured. Safety data were also collected., Results: Baseline SBA titers of > or =1/4 were observed in 87% of children after at least 3 doses of Men C vaccine in infancy compared with 21% of controls. Reciprocals of postvaccination SBA geometric mean titers in those with four prior doses [3803 (95% confidence interval 3489, 4146)] were significantly higher than controls [33 (95% confidence interval 20, 55)] ( < 0.001). Memory was attenuated by the 12-month meningococcal A/C polysaccharide booster [734 (95% confidence interval 484, 1115)] ( < 0.001). All children had IgG responses to a first dose of Men C vaccine, 80% achieving SBA titers of > or =1/4 (77% > or =1/8). The vaccine was safe and well-tolerated., Conclusion: Infant immunization with Men C produced persistent antibody and immunologic memory at 4 years. All children made IgG antibodies after a first dose at this age, with 80% showing bactericidal activity. Clarification of the best measures of Men C vaccine-induced protection is needed, through correlation of immunogenicity data such as this with UK vaccine efficacy estimates.

Asplenic or hyposplenic patients are at risk of fulminant sepsis. This entity has a mortality of up to 50%. The spectrum of causative organisms is evolving as are recommended preventive strategies, which include education, prophylactic and standby antibiotics, preventive immunizations, optimal antimalarial advice when visiting endemic countries and early management of animal bites. However, there is evidence that adherence to these strategies is poor. Consensus-updated guidelines have been developed to help Australian and New Zealand clinicians and patients in the prevention of sepsis in asplenic and hyposplenic patients. [ABSTRACT FROM AUTHOR]

In addition, we used the Victorian enhanced passive surveillance data as a reference to examine the timeliness of the telephone helpline data. B Methods & Materials: b Using data collected retrospectively from 1 February 2009 to 31 December 2017, weekly telephone helpline calls related to an AEFI were compared against the expected level estimated from historical data. [Extracted from the article]

Objectives: To determine the rate and severity of vesicular reactions following varicella vaccine in children with moderate–severe eczema. Secondary endpoints included the rates and severity of local reactions and eczema severity change within 42 days of vaccination. Methods: Prospective open intervention pilot study of varicella vaccine in children aged 12 months to 13 years with moderate–severe eczema. Children were given varicella vaccine alone and followed for 42 days after vaccination. Results: Fifty children, aged 12 months to 10.5 years were recruited, with complete follow-up for 48. A vesicular rash with a single lesion occurred in one child (2.1% (95% CI: 0, 11.1%)), 10 days following vaccination. Local reactions, including erythema, swelling and tenderness, were reported in eight children (16.7%). A flare-up of moderate–severe generalized eczema was reported in one child (2.1%) during the first week following varicella vaccine. Conclusions: Vesicular rash and local reactions following varicella vaccination were no more common or severe in children with moderate–severe eczema than that reported in the published literature in children without eczema. Eczema in the 42 days following vaccination did not appear to increase in severity. [ABSTRACT FROM AUTHOR]