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Nolan T.,Murdoch Childrens Research Institute | Richmond P.,University of Western Australia | Richmond P.,Telethon Institute for Child Health Research | Marshall H.,University of Adelaide | And 9 more authors.
Pediatric Infectious Disease Journal | Year: 2011

BACKGROUND: Neisseria meningitidis serogroups B, C, and Y cause most meningococcal disease in industrialized countries. A Haemophilus influenzae type b-meningococcal serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY-TT) was evaluated. METHODS: A total of 1104 infants (randomized 3:1:1) were vaccinated at 2, 4, and 6 months with HibMenCY-TT, MenC-CRM197 + Hib-TT, or Hib-TT. At 12 to 15 months, HibMenCY-TT and MenC-CRM-primed children received HibMenCY-TT; Hib-TT-primed received N. meningitidis serogroup B Hib-outer membrane protein complex. Antibody concentrations and rabbit/human complement serum bactericidal antibody titers (rSBA/hSBA) were determined. Safety was monitored after each dose (diary cards for first 31 days) until 6 months postdose 4. RESULTS: Postdose 3, rates of antipolyribosylribitol phosphate ≥1 μg/mL and rSBA-MenC ≥1:128 in HibMenCY-TT recipients were noninferior to licensed controls. Percentages reaching 0.15 μg/mL (1.0 μg/mL postdose 3) and antipolyribosylribitol phosphate GMC were significantly higher after HibMenCY-TT than Hib-TT postdose 2 and postdose 3. The GMC remained significantly higher before and after dose 4. Proportions of HibMenCY-TT recipients with rSBA ≥1:8 were 95.6% (MenC), 98.6% (MenY) postdose-2, ≥99% for MenC/Y postdose 3 and 4; hSBA ≥1:4 were 95.5% (MenC), 89.8% (MenY) postdose 2, >97% for MenC/Y postdose 3 and 4. HibMenCY-TT had a similar safety profile to control vaccines. CONCLUSIONS: HibMenCY-TT induced noninferior Hib and MenC responses compared with monovalent Hib and MenC conjugates with a comparable safety profile. Bactericidal antibodies against MenC/Y were induced after 2 doses of HibMenCY-TT. © 2011 Lippincott Williams & Wilkins, Inc. Source


Khandaker G.,National Center for Immunisation Research | Khandaker G.,University of Sydney | Zurynski Y.,University of Sydney | Zurynski Y.,Australian Paediatric Surveillance Unit | And 20 more authors.
Neurology | Year: 2012

Objective: We sought to determine the range and extent of neurologic complications due to pandemic influenza A (H1N1) 2009 infection (pH1N1'09) in children hospitalized with influenza. Methods: Active hospital-based surveillance in 6 Australian tertiary pediatric referral centers between June 1 and September 30, 2009, for children aged <15 years with laboratoryconfirmed pH1N1'09. Results: A total of 506 children with pH1N1'09 were hospitalized, of whom 49 (9.7%) had neurologic complications; median age 4.8 years (range 0.5-12.6 years) compared with 3.7 years (0.01-14.9 years) in those without complications. Approximately one-half (55.1%) of the children with neurologic complications had preexisting medical conditions, and 42.8% had preexisting neurologic conditions. On presentation, only 36.7% had the triad of cough, fever, and coryza/ runny nose, whereas 38.7% had only 1 or no respiratory symptoms. Seizure was the most common neurologic complication (7.5%). Others included encephalitis/encephalopathy (1.4%), confusion/disorientation (1.0%), loss of consciousness (1.0%), and paralysis/Guillain-Barre' syndrome (0.4%). A total of 30.6% needed intensive care unit (ICU) admission, 24.5% required mechanical ventilation, and 2 (4.1%) died. The mean length of stay in hospital was 6.5 days (median 3 days) and mean ICU stay was 4.4 days (median 1.5 days). Conclusions: Neurologic complications are relatively common among children admitted with influenza, and can be life-threatening. The lack of specific treatment for influenza-related neurologic complications underlines the importance of early diagnosis, use of antivirals, and universal influenza vaccination in children. Clinicians should consider influenza in children with neurologic symptoms even with a paucity of respiratory symptoms. © 2012 by AAN Enterprises, Inc. Source


Marshall H.,University of Adelaide | Marshall H.,Vaccinology and Immunology Research Trials Unit | Clarke M.,Vaccinology and Immunology Research Trials Unit | Rasiah K.,Vaccinology and Immunology Research Trials Unit | And 8 more authors.
Pediatric Infectious Disease Journal | Year: 2015

Background: Australia recently experienced its worst pertussis epidemic since introduction of pertussis vaccine into the National Immunisation Program. This study aimed to determine factors associated with severe pertussis in hospitalized children during an epidemic using a novel pertussis severity scoring (PSS) system. Methods: This prospective, observational, multicenter study enrolled children hospitalized with laboratory confirmed pertussis from 8 tertiary pediatric hospitals during a 12 month period (May 2009-April 2010). Variables assessed included demographics, clinical symptoms and relevant medical and immunization history. Cases were scored using objective clinical findings with cases classified as either severe (PSS > 5) or not severe (PSS ≤ 5). Logistic regression models were used to predict variables associated with severe disease. Results: One hundred twenty hospitalized children 0-17 years of age were enrolled with a median PSS of 5 (interquartile range 3-7). Most (61.7%) were classified as not severe with 38.3% (46/120) severe. Most severe cases (54.3%) were <2 months of age. Presence of coinfection [odds ratio (OR): 4.82, CI: 1.66-14.00], <2 months old (OR: 4.76, CI: 1.48-15.32), fever >37.5°C (OR: 5.97, CI: 1.19-29.96) and history of prematurity (OR: 5.00, CI: 1.27-19.71) were independently associated with severe disease. A total of 70 cases in children ≥2 months of age, almost a third (n = 23) had not received pertussis vaccine. Conclusions: Most severe pertussis occurred in young, unimmunized infants, although severe disease was also observed in children >12 months of age and previously vaccinated children. Children admitted with pertussis with evidence of coinfection, history of prematurity or fever on presentation need close monitoring. © 2015 Wolters Kluwer Health, Inc. Source


Hillier S.,University of South Australia | Grimmer-Somers K.,University of South Australia | Merlin T.,University of Adelaide | Middleton P.,University of Adelaide | And 3 more authors.
BMC Medical Research Methodology | Year: 2011

Background: Clinical practice guidelines are an important element of evidence-based practice. Considering an often complicated body of evidence can be problematic for guideline developers, who in the past may have resorted to using levels of evidence of individual studies as a quasi-indicator for the strength of a recommendation. This paper reports on the production and trial of a methodology and associated processes to assist Australian guideline developers in considering a body of evidence and grading the resulting guideline recommendations. Methods. In recognition of the complexities of clinical guidelines and the multiple factors that influence choice in health care, a working group of experienced guideline consultants was formed under the auspices of the Australian National Health and Medical Research Council (NHMRC) to produce and pilot a framework to formulate and grade guideline recommendations. Consultation with national and international experts and extensive piloting informed the process. Results: The FORM framework consists of five components (evidence base, consistency, clinical impact, generalisability and applicability) which are used by guideline developers to structure their decisions on how to convey the strength of a recommendation through wording and grading via a considered judgement form. In parallel (but separate from the grading process) guideline developers are asked to consider implementation implications for each recommendation. Conclusions: The framework has now been widely adopted by Australian guideline developers who find it to be a logical and intuitive way to formulate and grade recommendations in clinical practice guidelines. © 2011 Hillier et al; licensee BioMed Central Ltd. Source


Clarke M.,Vaccinology and Immunology Research Trials Unit | Clarke M.,University of Adelaide | Thomas N.,Previously employed at Vaccinology and Immunology Research Trials Unit | Giles L.,University of Adelaide | And 2 more authors.
Vaccine | Year: 2015

Objective: Pertussis is a highly virulent vaccine preventable disease that remains a global challenge. This study aimed to assess community knowledge of pertussis infection as well as awareness and uptake of adult pertussis booster vaccine. Methods: A cross-sectional survey was conducted of randomly selected households in South Australia by Computer Assisted Telephone Interviews in 2011. Survey data were weighted to the age, gender and geographical area profile of the population. Results: From 3124 randomly sampled contactable households, 1967 interviews were conducted (participation rate 63%) with individuals aged 18-93 years, including 608 parents of children aged <18 years. The majority of respondents (97%) had heard of pertussis (whooping cough) and 18% reported that a household member had previously contracted whooping cough infection. Most respondents considered whooping cough to be highly contagious (73%) and severe for infants (89%). Over half (51%) of those surveyed were aware that family members commonly transmit pertussis to infants. Despite high knowledge, pertussis vaccine uptake was low, with only 10% of respondents reporting pertussis vaccination in the previous five years. Whilst 61% of respondents were aware of the availability of an adult pertussis booster vaccine, only 8% (n= 154) reported their Family Physician had discussed it with them. If provided free, 77% agreed that they would be more likely to accept a booster pertussis vaccination. Independent predictors of recent pertussis vaccination included higher education, larger household size, perception of greater disease severity for infants and discussion with a Family Physician about pertussis vaccination. Conclusions: Whilst knowledge regarding transmission and severity of Bordetella pertussis was high, uptake of pertussis vaccination for adults is remarkably low amongst the South Australian community. Improved awareness regarding the availability of a booster pertussis vaccine through Family Physicians and/or provision of funded pertussis vaccination for adults has the potential to improve pertussis vaccine coverage. © 2015 Elsevier Ltd. Source

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